78 results on '"Balu Maliakel"'
Search Results
2. Two-Stage Supramolecular Self-Assembly-Directed Collagen-Peptide-Decorated Liposomal Complexes of Curcumin Microspheres with Enhanced Solubility and Bioavailability
- Author
-
Maria Jose Louis, Abhilash Balakrishnan, Ashil Joseph, Prasanth Shanmughan, Balu Maliakel, and Krishnakumar Illathu Madhavamenon
- Subjects
Chemistry ,QD1-999 - Published
- 2023
- Full Text
- View/download PDF
3. Enhanced Bioavailability and Pharmacokinetics of a Natural Self-Emulsifying Reversible Hybrid-Hydrogel System of Quercetin: A Randomized Double-Blinded Comparative Crossover Study
- Author
-
Ashil Joseph, Prasanth Shanmughan, Abhilash Balakrishnan, Balu Maliakel, and Krishnakumar I M
- Subjects
Chemistry ,QD1-999 - Published
- 2022
- Full Text
- View/download PDF
4. Micelle/Hydrogel Composite as a 'Natural Self-Emulsifying Reversible Hybrid Hydrogel (N’SERH)' Enhances the Oral Bioavailability of Free (Unconjugated) Resveratrol
- Author
-
Ashil Joseph, Abhilash Balakrishnan, Prasanth Shanmughan, Balu Maliakel, and Krishnakumar Illathu Madhavamenon
- Subjects
Chemistry ,QD1-999 - Published
- 2022
- Full Text
- View/download PDF
5. A phase I clinical trial to evaluate the safety of thymoquinone-rich black cumin oil (BlaQmax®) on healthy subjects: Randomized, double-blinded, placebo-controlled prospective study
- Author
-
Jestin V. Thomas, M.E. Mohan, Prathibha Prabhakaran, Syam Das S, Balu Maliakel, and Krishnakumar I.M.
- Subjects
Black cumin ,Black seed ,Nigella sativa ,Thymoquinone ,Safety ,Toxicology. Poisons ,RA1190-1270 - Abstract
Black cumin or black seed (Nigella sativa L.) is a popular medicinal herb and culinary spice belonging to Ranunculacea family. Thymoquinone (TQ) is the major active phytoconstituent in black cumin and is abundant in the volatile oil fraction. Though black cumin oil containing low TQ content (less than 1%) has been clinically investigated, clinical efficacy and safety data of TQ-rich oil is limited. A recent study with black cumin oil formulation containing 5% TQ (BCO-5) exhibited significant clinical efficacy to alleviate sleep disorders and stress. So, the present phase 1 randomized, double-blinded, placebo-controlled trial evaluated the safety of BCO-5 at a dose of 200 mg/adult/day for 90 days on healthy subjects (n = 70). Both the biochemical and hematological parameters were analysed along with the adverse events or side effects to establish the clinical safety of BCO-5. The study reported neither serious adverse side effects nor any significant alterations in the hematological parameters. The absence of significant changes in the biochemical parameters related to liver function (ALT, AST, ALP), renal function (serum creatinine and urea) were also observed. However, analysis of lipid profile showed a significant (P
- Published
- 2022
- Full Text
- View/download PDF
6. Safety and influence of a novel extract of fenugreek on healthy young women: a randomized, double-blinded, placebo-controlled study
- Author
-
Aman Khanna, Jestin Thomas, Febi John, Balu Maliakel, and I. M. Krishnakumar
- Subjects
Fenugreek ,Irritability ,Menopausal rating scale ,Sexual problems ,Trigonella foenum-graecum ,Women ,Medicine ,Homeopathy ,RX1-681 - Abstract
Abstract Background Fenugreek (Trigonella foenum-graecum) seed is a popular kitchen spice and medicinal herb with wide applications in Indian folklore. Earlier studies have shown that the hydro-ethanolic extracts of fenugreek are efficient in the management of a number of hormone related disorders in women, including post and peri-menopausal discomforts, sexual dysfunctions, lactation and even in amenorrhea. However, systematic informations on their safety and influence on hormonal balance are limited. Results Forty-eight healthy menstruating women aged 20 to 48 were randomized either to FHE (n = 24) or placebo (n = 24) and supplemented with 250 mg × 2/day for 42 days. FHE did not produce any side effects or adverse events. It offered significant (P 1) when monitored by the validated Menopausal Rating Scale (MRS) scale. Further, hormone analysis indicated an enhancement in estradiol (P = 0.040), free testosterone (P = 0.025), and total testosterone (P = 0.012) in FHE group in comparison to placebo. There were no significant changes in progesterone (P = 0.174) and FSH (P = 0.879) upon FHE supplementation. The hematological and biochemical safety parameters were also at par with the safety of the extract. Conclusion Thus, the supplementation of FHE may be considered as a natural alternative for sexual issues in women. Trial registration CTRI/2018/09/015614 dated 05/09/2018.
- Published
- 2021
- Full Text
- View/download PDF
7. Safety assessment of a highly bioavailable curcumin-galactomannoside complex (CurQfen) in healthy volunteers, with a special reference to the recent hepatotoxic reports of curcumin supplements: A 90-days prospective study
- Author
-
Vaibhavi Pancholi, Thozhuthum Parambil Smina, Ajaikumar B. Kunnumakkara, Balu Maliakel, and Illathu Madhavamenon Krishnakumar
- Subjects
Bioavailability ,Curcumin ,Curcumin-galactomannoside complex ,CurQfen ,Hepatotoxicity ,Human study ,Toxicology. Poisons ,RA1190-1270 - Abstract
Recently, there is a growing concern about the use of curcumin supplements owing to a few reported hepatotoxicity related adverse events among some of the long-term consumers. Even though no clear evidence was elucidated for the suspected toxicity, the addition of adjuvants that inhibits body’s essential detoxification pathways, adulteration with synthetic curcumin, and presence of contaminants including heavy metals, chromate, illegal dyes, non-steroidal anti-inflammatory agents, and pyrrole alkaloids were suggested as plausible reasons. Considering these incidences and speculations, there is a need to critically evaluate the safety of curcumin supplements for prolonged intake. The present study is an evaluation of the safety of curcumin-galactomannoside complex (CGM), a highly bioavailable curcumin formulation with demonstrated high free curcuminoids delivery. Twenty healthy human volunteers were evaluated for toxic manifestations of CGM when supplemented with 1000 mg per day (∼380 mg curcuminoids) for 90-days. CGM supplementation did not cause any adverse effects or clinically significant variations in the vital signs, hematological parameters, lipid profile and renal function markers of the volunteers, indicating its safety. Liver function enzymes aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT) and bilirubin were in the normal range after 90-day supplementation of CGM. In summary, no adverse effects were observed under the conditions of the study. CGM can be considered as a safe curcumin supplement for regular consumption and is devoid of any adulterants or contaminants.
- Published
- 2021
- Full Text
- View/download PDF
8. Safety assessment of a fenugreek dietary fiber-based formulation of capsaicinoids-rich red chili (Capsicum annum) extract (Capsifen®): Acute and sub-chronic studies
- Author
-
Ashil Joseph, Johannah NM, Suresh Kumar, Syam Das S, Balu Maliakel, and Krishnakumar IM
- Subjects
Capsifen ,Red chili pepper ,Capsicum annum ,Fenugreek dietary fiber ,Sustained-release ,Safety ,Toxicology. Poisons ,RA1190-1270 - Abstract
Despite the promising health beneficial effects (thermogenic, lipolytic, hypotriglyceridemic, hypocholesterolemic, anti-inflammatory and anticancer) of capsaicinoids-rich red chili pepper, commonly known as cayenne pepper (Capsicum annum or Capsicum frutescence), its consumption at physiologically relevant dosage is always hampered by the pungency and stomach discomforts. The present study examined the safety of a pungency-masked and sustained release food-grade formulation of capsaicinoids-rich red chili pepper extract using fenugreek derived galactomannan soluble dietary fiber (Capsifen®). The safety was assessed by oral acute (300, 2000, 5000 mg/kg b. wt. for 14 days) and subchronic (250, 500 and 1000 mg/kg b. wt.) toxicity studies in Wistar rats. None of the group of animals belonging to both acute and subchronic treatments did produce any adverse events in feeding behavior, urine analysis, and in hematology/biochemical parameters when compared to the control. However, a decrease in body weight was observed among 500 and 1000 mg/kg b. wt. treated groups. The terminal autopsy did not reveal any alterations in relative organ weight except for the high dose treated group, where an increase in liver and kidney weight was observed. Histopathology of all the animals was normal. Thus, the Low-observed-adverse-effect level (LOAEL) of Capsifen was determined for 500 mg/kg b. wt. /day.
- Published
- 2020
- Full Text
- View/download PDF
9. Enhanced bioavailability and pharmacokinetics of a novel hybrid-hydrogel formulation of fisetin orally administered in healthy individuals: a randomised double-blinded comparative crossover study
- Author
-
Illathu Madhavamenon Krishnakumar, Asha Jaja-Chimedza, Ashil Joseph, Abhilash Balakrishnan, Balu Maliakel, and Andrew Swick
- Subjects
Bioavailability ,Fenugreek galactomannans ,Fenumat ,Fisetin ,Flavonoids ,Pharmacokinetics ,Nutrition. Foods and food supply ,TX341-641 ,Medicine - Abstract
Fisetin, a polyphenol found in several fruits and vegetables, has shown potential health benefits in many pre-clinical studies for neuroprotection, cardioprotection, chemoprevention, diabetes, inflammation and oxidative stress. However, the clinical effectiveness of fisetin may be limited by its poor bioavailability when ingested. Using a novel green technology of Hybrid-FENUMAT™, a food-grade fisetin formulation (FF-20) was developed through encapsulation of fisetin micelles into fenugreek galactomannan (FG) hydrogel scaffold to improve its physical characteristics and bioavailability. This is the first human pharmacokinetic study of fisetin following a single-dose, comparative, double-blinded, cross-over protocol, supplementing with FF-20 and unformulated fisetin (UF). Fifteen healthy volunteers were given a single dose of 1000 mg UF or 1000 mg FF-20 (delivering 192 mg fisetin) with a 10-d washout period between each dose. Blood samples were taken at 0⋅5, 1, 2, 3, 5, 8 and 12 h after both days of supplementation to quantify fisetin and geraldol, an active metabolite. The plasma concentration of fisetin when individuals consumed FF-20 was 26⋅9-fold greater than UF as determined by the area under the curve over 12 h [AUC0–12 h (FF-20) = 341⋅4 v. AUC0–12 h (UF) = 12⋅67]. The maximum plasma concentration (Cmax) was also more than twenty-three times higher when supplemented with FF-20 (238⋅2 ng/ml) compared to UF (9⋅97 ng/ml). The encapsulation also reduced the amount of conversion of fisetin to geraldol. No adverse events were reported during the study. Therefore, the encapsulation of fisetin into FG dietary fibre hydrogel scaffold could improve its delivery and bioavailability in human subjects.
- Published
- 2022
- Full Text
- View/download PDF
10. A green approach for the sustained-intestinal delivery of red chili (Capsicum annum L) extracted capsaicinoids with enhanced bioavailability
- Author
-
Ashil Joseph, Abhilash Maliakkal Balakrishnan, Johannah Natinga Mulakal, Syam Das Sivadasan, Ratheesh Mohan, Balu Maliakel, and Krishnakumar Illathu Madhavamenon
- Subjects
Beadlets ,Capsicum annum L ,Capsaicin ,Capsifen ,Fenugreek dietary fiber ,Hydrogel ,Nutrition. Foods and food supply ,TX341-641 - Abstract
Intestinal delivery with enhanced bioavailability is of great significance for stomach irritating and pungent bioactive molecules. The present study reports the development of a pungency-masked food-grade microbeadlets for the sustained-intestinal delivery of red chili extracted capsaicinoids using fenugreek galactomannans. Capsaicinoids encapsulated microbeads (CapF) of about 250 to 400 µm were prepared by a gel-phase homogenization, fluid-bed granulation followed by galactomannan coating, and characterized by NMR, FTIR, DSC, PXRD, and SEM as stable, directly compressible, free flowing amorphous beadlets with a tap density of 0.64 ± 0.2 g/mL. Swelling studies, in vitro release kinetics and particle size analysis indicated the intestinal delivery of soluble capsaicinoids. Pharmacokinetic studies on Wistar rats revealed enhanced bioavailability (19-fold) of CapF when the area under plasma concentration verses time was compared with that of unformulated capsaicinoids. CapF was safe upon gastric mucosa irritation test and demonstrated significant (P
- Published
- 2021
- Full Text
- View/download PDF
11. Enhanced absorption of curcuminoids and 3-Acetyl-11-keto-β-boswellic acid from fenugreek galactomannan hydrogel beadlets: A natural approach to the co-delivery of lipophilic phytonutrients
- Author
-
Maliakkal Balakrishnan Abhilash, Dinesh Kumar, Ayswaria Deepti, Aswathi Nair, Vanheule Greet, Vynckier An-Katrien, Van Den Driessche Mieke, Syam Das Sivadasan, Balu Maliakel, Baby Chakrapani PS, and Krishnakumar Illathu Madhavamenon
- Subjects
Bioavailability ,Boswellic acids ,Curcuminoids ,Co-delivery ,Fenugreek dietary fiber ,Hydrogel, Self-emulsifying beadlets ,Nutrition. Foods and food supply ,TX341-641 - Abstract
Simultaneous oral delivery of bioactive molecules with enhanced bioavailability is of great significance, especially when delivered from single beadlets. Here, we report the formulation, characterization, and pharmacokinetic properties of two poorly bioavailable lipophilic phytonutrients with synergistic effects, curcuminoids and 3-Acetyl-11-keto-β-boswellic acid (AKBA), following their co-delivery using fenugreek dietary fiber (Galactomannans)-based hydrogel beadlets (CGM-BSW). These beadlets are capable of extensive swelling and sustained-release of self-emulsified colloidal particles (150 – 200 nm) containing curcuminoids and AKBA allowing for improved absorption. The results of our double-blinded 4-way crossover, 4-sequence study (n = 14) demonstrated that a single dose of 250 mg of these beadlets enhanced the absorption of unconjugated curcuminoids (24.8-fold) and AKBA (6.9-fold) compared to their unformulated counterparts. The absorption of CGM-BSW formulated curcuminoids was also 5.6-fold higher than that of those formulated with turmerones (UCT). UPLC-ESI-QQQ-MS/MS was used to quantify both the curcuminoids and AKBA concentration in the plasma samples and this data was used to determine their pharmacokinetic characteristics.
- Published
- 2021
- Full Text
- View/download PDF
12. Dietary addition of a standardized extract of turmeric (TurmaFEEDTM) improves growth performance and carcass quality of broilers
- Author
-
Johannah NM, Ashil Joseph, Balu Maliakel, and Krishnakumar IM
- Subjects
Turmeric ,Antioxidant activity ,Phytogenics ,Growth promoter ,Carcass traits ,Broiler ,Animal culture ,SF1-1100 - Abstract
Abstract Background Indiscriminate use of antibiotics in livestock and poultry farming has caused emergence of new pathogenic strains. The situation has warrented the development of safe and alternative growth promoters and immunity enhancers in livestock. Herbal additives in animal and bird feed is a centuries-old practice. Thus, the present study investigated the efficacy of a standardized formulation of lipophilic turmeric extract containing curcumin and turmerones, (TF-36), as a natural growth promoter poultry feed additive. Methods The study was designed on 180 one-day old chicks, assigned into three groups. Control group (T0) kept on basal diet and supplemented groups T0.5 and T1 fed with 0.5% and 1% TF-36 fortified basal diet for 42 days. Each dietary group consisted of six replicates of ten birds. Body weight, food intake, food conversion ratio, skin colour, blood biochemical analysis and antioxidant status of serum were investigated. Results Body weight improved significantly in T1 with a 10% decrease in FCR as compared to the control. TF-36 supplementation in T1 enhanced the antioxidant enzyme activity significantly (p
- Published
- 2018
- Full Text
- View/download PDF
13. Toxicological evaluation of a saponin-rich standardized extract of fenugreek seeds (FenuSMART®): Acute, sub-chronic and genotoxicity studies
- Author
-
D. Sureshkumar, Shamshad Begum, N.M. Johannah, Balu Maliakel, and I.M. Krishnakumar
- Subjects
Toxicology. Poisons ,RA1190-1270 - Abstract
The present study investigated the safety of a saponin-rich standardized extract of fenugreek seeds (FenuSMART®; FHE), that has been clinically shown to be effective in ameliorating the postmenopausal discomforts and establishing hormonal balance. The safety was assessed by oral acute (2500 mg/kg b. wt. for 14 days) and subchronic (250, 500 and 1000 mg/kg b. wt. for 90 days) toxicity studies on Wistar rats and mutagenicity studies employing Salmonella typhimurium strains. Administration of FHE did not produce any toxicologically significant changes in clinical/behavioral observations, ophthalmic examinations, body weight, organ weight, feed consumption, urinalysis, hematology and clinical biochemistry parameters when compared to the untreated control group of animals. Highest dose recovery group (1000 mg/kg b. wt.) of animals also showed no mortality or adverse events; with hematological and biochemical parameters at par with those of controls. Terminal autopsy revealed no alterations in relative organ weight or any treatment-related histopathology changes. FHE also showed no mutagenicity upon Ames test employing TA-98, TA-100 and TA-102 Salmonella typhimurium strains with or without metabolic activation. Based on the results of the study, the no observed-adverse-effect level (NOAEL) of FHE was determined as 1000 mg/kg b. wt./day, the highest dose tested. Keywords: Fenugreek extract, Trigonella foenum graecum, Phytoestrogen, Menopause, Subchronic toxicity, Genotoxicity
- Published
- 2018
- Full Text
- View/download PDF
14. Beyond the flavor: A green formulation of Ferula asafoetida oleo-gum-resin with fenugreek dietary fibre and its gut health potential
- Author
-
Liju Vijayasteltar, I.J. Jismy, Ashil Joseph, Balu Maliakel, Ramadasan Kuttan, and Krishnakumar I.M.
- Subjects
Toxicology. Poisons ,RA1190-1270 - Abstract
Albeit the fact that asafotida is a popular kitchen spice and Indian folklore medicine for gut disorders, its consumption at physiologically relevant dosage is greatly challenged by the unpleasant flavor characteristics. Herein we report a green approach to derive stable powder formulations of asafoetida gum with minimized taste and odor suitable for dietary applications and gut health-related disorders. Employing a water based ultrasound mediated gel-phase dispersion of asafoetida gum on fenugreek derived soluble galactomannan fibre matrix. Microencapsulated particles (1 ± 0.3 μm) of asafoetida was prepared as water dispersible free flowing powder (Asafin). Fourier-transform infrared spectroscopy (FTIR), scanning electron microscopy (SEM), accelerated stability and in vitro dissolution studies confirmed the stability, sustained release and microencapsulated structure of Asafin. Further investigations revealed significant (pÂ
- Published
- 2017
- Full Text
- View/download PDF
15. Enhanced bioavailability and relative distribution of free (unconjugated) curcuminoids following the oral administration of a food-grade formulation with fenugreek dietary fibre: A randomised double-blind crossover study
- Author
-
Dinesh Kumar, Della Jacob, Subash PS, Abhilash Maliakkal, Johannah NM, Ramadassan Kuttan, Balu Maliakel, Veera Konda, and Krishnakumar IM
- Subjects
Curcumin ,Curcuminglucuronide ,Conjugated curcumin metabolites ,Bioavailability ,Pharmacokinetics ,Oral administration ,Nutrition. Foods and food supply ,TX341-641 - Abstract
Despite the various reports on enhanced bioavailable formulations of curcumin, systemic oral bioavailability of unconjugated curcuminoids remains a challenge. Considering the differences in plasma bioactivity and membrane permeability of free curcuminoids over conjugated metabolites, herein we report a randomised double-blinded crossover study (n = 50) to investigate the relative bioavailability and pharmacokinetics of free curcuminoids following the oral administration of high (1000 mg) and low (250 mg) doses of a food-grade formulation of curcumin with fenugreek dietary fibre as curcumagalactomannosides (CGM), which was reported to exhibit improved blood-brain – barrier permeability in rats. CGM administration provided over 45.5-fold enhancement in free curcuminoids bioavailability with improved pharmacokinetics when compared to unformulated standard curcumin. Further investigations with and without enzymatic hydrolysis of plasma collected over 5 h post-administration of CGM at 1000 mg dose revealed higher free curcuminoids in plasma (74 ± 8%) as compared to conjugated curcuminoids (26 ± 12%) indicating a significant distribution of free curcuminoids over conjugated curcumin metabolites.
- Published
- 2016
- Full Text
- View/download PDF
16. Safety assessment of a standardized polyphenolic extract of clove buds: Subchronic toxicity and mutagenicity studies
- Author
-
Liju Vijayasteltar, Gopakumar Gopinathan Nair, Balu Maliakel, Ramadasan Kuttan, and Krishnakumar I.M.
- Subjects
Toxicology. Poisons ,RA1190-1270 - Abstract
Despite the various reports on the toxicity of clove oil and its major component eugenol, systematic evaluations on the safety of polyphenolic extracts of clove buds have not been reported. Considering the health beneficial pharmacological effects and recent use of clove polyphenols as dietary supplements, the present study investigated the safety of a standardized polyphenolic extract of clove buds (Clovinol), as assessed by oral acute (5 g/kg b.wt. for 14 days) and subchronic (0.25, 0.5 and 1 g/kg b.wt. for 90 days) toxicity studies on Wistar rats and mutagenicity studies employing Salmonella typhimurium strains. Administration of Clovinol did not result in any toxicologically significant changes in clinical/behavioural observations, ophthalmic examinations, body weights, organ weights, feed consumption, urinalysis, hematology and clinical biochemistry parameters when compared to the untreated control group of animals, indicating the no observed-adverse-effect level (NOAEL) as 1000 mg/kg b.wt./day; the highest dose tested. Terminal necropsy did not reveal any treatment-related histopathology changes. Clovinol did not show genotoxicity when tested on TA-98, TA-100 and TA-102 with or without metabolic activation; rather exhibited significant antimutagenic potential against the known mutagens, sodium azide, NPD and tobacco as well as against 2-acetamidoflourene, which needed metabolic activation for mutagenicity. Keywords: Syzygium aromaticum, Clove bud extract, Polyphenol, Subchronic toxicity, Mutagenicity, Genotoxicity
- Published
- 2016
- Full Text
- View/download PDF
17. Enhanced absorption and pharmacokinetics of fresh turmeric (Curcuma Longa L) derived curcuminoids in comparison with the standard curcumin from dried rhizomes
- Author
-
IM Krishnakumar, Dinesh Kumar, Eapen Ninan, Ramadassan Kuttan, and Balu Maliakel
- Subjects
Bioavailability ,Pharmacokinetics ,Curcuma longa L ,Curcumin ,Fresh rhizomes ,Turmeric ,Nutrition. Foods and food supply ,TX341-641 - Abstract
Despite the various attempts to overcome the poor oral bioavailability of curcuminoids isolated from dried turmeric, no attempt has so far been reported on fresh turmeric derived curcuminoids. Herein, we report a novel preparation of curcuminoids from fresh turmeric rhizomes (FTC) as amorphous water soluble stable powder and its enhanced absorption and pharmacokinetics in comparison with 95% pure curcuminoids isolated from dried turmeric (DTC). While the oral administration of FTC at 250 mg/kg body weight was found to offer significant levels of plasma curcumin in Wistar rats for longer duration, an equivalent dose of curcuminoids as DTC failed to produce detectable plasma levels. Dose dependent human studies (100, 250 and 1000 mg doses of FTC) also showed significant (p
- Published
- 2015
- Full Text
- View/download PDF
18. Improved blood–brain-barrier permeability and tissue distribution following the oral administration of a food-grade formulation of curcumin with fenugreek fibre
- Author
-
Krishnakumar IM, Abhilash Maliakel, Gopakumar G, Dinesh Kumar, Balu Maliakel, and Ramadasan Kuttan
- Subjects
Curcumin ,Oral bioavailability ,Functional food ,Blood–brain-barrier ,Tissue distribution ,Pharmacokinetics ,Nutrition. Foods and food supply ,TX341-641 - Abstract
The delivery of significant concentrations of biologically active free curcuminoids (curcumin, demethoxycurcumin and bisdemethoxycurcumin) at the target tissues has always been regarded as a major limitation for the efficacy of curcumin. Herein we report the blood–brain-barrier permeability, tissue distribution and enhanced bioavailability of free curcuminoids following the oral administration of a food grade curcumin formulation in comparison with the standardized native curcumin, for the first time. UPLC-ESI-MS/MS analyses of post-administration tissue samples of Wistar rats (200 mg/kg body weight) demonstrated significant (p
- Published
- 2015
- Full Text
- View/download PDF
19. Enhanced anti-diabetic activity of polyphenol-rich de-coumarinated extracts of Cinnamomum cassia
- Author
-
Krishna Kumar, IM, Abin Issac, Eapen Ninan, Ramadassan Kuttan, and Balu Maliakel
- Subjects
Cinnamomum cassia ,Polyphenols ,Oligomeric procyanidins ,Coumarin ,Diabetes mellitus ,Nutrition. Foods and food supply ,TX341-641 - Abstract
Although the insulin potentiating activity of Cinnamomum cassia extracts has been studied in detail, no systematic investigations have so far been reported to standardize those extracts with respect to their bioactive polyphenol and toxic coumarin contents. Moreover, no process has been reported for the preparation of de-coumarinated water-soluble polyphenol-rich extracts of cinnamomum species. In the present contribution, we describe the preparation of de-coumarinated polyphenol-rich extracts of Cinnamomum cassia containing 45 and 70% gallic acid equivalents of polyphenol content and their characterization by tandem mass spectrometry. These extracts were investigated for their relative anti-hyperglycaemic effects in comparison with a standard aqueous extract containing 18% polyphenol content and 0.8% coumarin. De-coumarinated extracts were found to be safe and showed 3.4 fold enhancements in relative lowering of blood sugar levels as compared to the standard cinnamon extract, when administered to streptozotocin-induced diabetic rats at 200 mg/kg body weight for 30 days.
- Published
- 2014
- Full Text
- View/download PDF
20. An enhanced bioavailable formulation of curcumin using fenugreek-derived soluble dietary fibre
- Author
-
Krishnakumar IM, Abhilash Ravi, Dinesh Kumar, Ramadasan Kuttan, and Balu Maliakel
- Subjects
Bioavailability ,Curcumin ,Controlled-release ,Fenugreek ,Soluble fibre ,Ultrasound ,Nutrition. Foods and food supply ,TX341-641 - Abstract
Poor intestinal absorption has been regarded as a major limiting factor for the therapeutic use of curcumin, the primary active constituent of turmeric. Herein, we investigated the bioavailability of a novel formulation of curcumin-impregnated soluble dietary fibre dispersions (BR213 curcumagalactomannosides) comprising an extensive gel forming and non-digestible soluble galactomannan fibre derived from the spice fenugreek. The dispersions were prepared as microgranulates of mean particle size 150 ± 20 μm by an ultrasound mediated gel-phase dispersion technique. In vitro release studies at pH 1.2 and 6.8 showed slow and prolonged release of colloidal curcumin from the amorphous microgranulates of curcumin-impregnated soluble fibre. Enhanced bioavailability of the new formulation was further demonstrated in animals (Wistar rats) and human volunteers in comparison with unformulated curcumin. It was observed that the relative absorption of curcumin from the novel fibre formulation, as evident from the area under curve calculations, was 20 times higher in animals and 15.8 times higher in humans when supplemented orally. Maximum absorption was also found to be prolonged as compared to the unformulated curcumin.
- Published
- 2012
- Full Text
- View/download PDF
21. Safety and influence of a novel extract of fenugreek on healthy young women: a randomized, double-blinded, placebo-controlled study
- Author
-
Jestin V Thomas, Febi John, Krishnakumar Im, Balu Maliakel, and Aman Khanna
- Subjects
0301 basic medicine ,Trigonella ,Fenugreek ,Placebo-controlled study ,Physiology ,Placebo ,Menopausal rating scale ,03 medical and health sciences ,0302 clinical medicine ,Diabetes mellitus ,medicine ,Women ,Trigonella foenum-graecum ,Adverse effect ,Testosterone ,General Environmental Science ,biology ,business.industry ,RX1-681 ,Homeopathy ,biology.organism_classification ,medicine.disease ,Irritability ,030104 developmental biology ,030220 oncology & carcinogenesis ,General Earth and Planetary Sciences ,Medicine ,Amenorrhea ,medicine.symptom ,business ,Sexual problems ,Hormone - Abstract
BackgroundFenugreek (Trigonella foenum-graecum) seed is a popular kitchen spice and medicinal herb with wide applications in Indian folklore. Earlier studies have shown that the hydro-ethanolic extracts of fenugreek are efficient in the management of a number of hormone related disorders in women, including post and peri-menopausal discomforts, sexual dysfunctions, lactation and even in amenorrhea. However, systematic informations on their safety and influence on hormonal balance are limited.ResultsForty-eight healthy menstruating women aged 20 to 48 were randomized either to FHE (n = 24) or placebo (n = 24) and supplemented with 250 mg × 2/day for 42 days. FHE did not produce any side effects or adverse events. It offered significant (P 1) when monitored by the validated Menopausal Rating Scale (MRS) scale. Further, hormone analysis indicated an enhancement in estradiol (P = 0.040), free testosterone (P = 0.025), and total testosterone (P = 0.012) in FHE group in comparison to placebo. There were no significant changes in progesterone (P = 0.174) and FSH (P = 0.879) upon FHE supplementation. The hematological and biochemical safety parameters were also at par with the safety of the extract.ConclusionThus, the supplementation of FHE may be considered as a natural alternative for sexual issues in women.Trial registrationCTRI/2018/09/015614dated 05/09/2018.
- Published
- 2021
22. Surface-engineered liposomal particles of calcium ascorbate with fenugreek galactomannan enhanced the oral bioavailability of ascorbic acid: a randomized, double-blinded, 3-sequence, crossover study
- Author
-
Ashil Joseph, Balu Maliakel, Abhilash Maliakkal Balakrishnan, Krishnakumar Im, Prasanth Shanmughan, and Dinesh Kumar
- Subjects
Liposome ,Antioxidant ,General Chemical Engineering ,medicine.medical_treatment ,Cmax ,General Chemistry ,Pharmacology ,Ascorbic acid ,Crossover study ,Bioavailability ,chemistry.chemical_compound ,Calcium ascorbate ,Pharmacokinetics ,chemistry ,medicine - Abstract
The antioxidant, anti-inflammatory, immunomodulating, anti-thrombotic, and antiviral effects along with its protective effects against respiratory infections have generated a great interest in vitamin C (vitC) as an attractive functional/nutraceutical ingredient for the management of COVID-19. However, the oral bioavailability and pharmacokinetics of vitC have been shown to be complex and exhibit dose-dependent non-linear kinetics. Though sustained-release forms and liquid liposomal formulations have been developed, only marginal enhancement was observed in bioavailability. Here we report a novel surface-engineered liposomal formulation of calcium ascorbate (CAAS), using fenugreek galactomannan hydrogel in powder form, and its pharmacokinetics following a randomized, double-blinded, single-dose, 3-way crossover study on healthy human volunteers (n = 14). The physicochemical characterization and in vitro release studies revealed the uniform impregnation of CAAS liposomes within the pockets created by the sterically hindered galactomannan network as multilaminar liposomal vesicles with good encapsulation efficiency (>90%) and their stability and sustained-release under gastrointestinal pH conditions. Further human studies demonstrated >7-fold enhancement in the oral bioavailability of ascorbate with a significant improvement in pharmacokinetic properties (Cmax, Tmax, T1/2, and AUC), compared to the unformulated counterpart (UF-CAAS) when supplemented at an equivalent dose of 400 mg of CAAS as tablets and capsules.
- Published
- 2021
23. Influence of a low‐dose supplementation of curcumagalactomannoside complex ( <scp>CurQfen</scp> ) in knee osteoarthritis: A randomized, open‐labeled, active‐controlled clinical trial
- Author
-
Aman Khanna, Balu Maliakel, Jestin V Thomas, Ratheesh Mohanan, Thozhuthum Parambil Smina, Krishnakumar Im, and Ajaikumar B. Kunnumakkara
- Subjects
Male ,Curcumin ,WOMAC ,Population ,Osteoarthritis ,Physical function ,Single oral dose ,03 medical and health sciences ,0302 clinical medicine ,Inflammatory marker ,Humans ,Medicine ,education ,Pharmacology ,Glucosamine ,0303 health sciences ,education.field_of_study ,business.industry ,030302 biochemistry & molecular biology ,Low dose ,Middle Aged ,Osteoarthritis, Knee ,medicine.disease ,Clinical trial ,Treatment Outcome ,030220 oncology & carcinogenesis ,Anesthesia ,Dietary Supplements ,Female ,business - Abstract
A 6-week, randomized, open-label, active-controlled clinical trial was conducted to evaluate the influence of a low-dose curcumagalactomannosides (CGM) (400 mg once daily) in OA subjects. The treatment was compared with a standard combination of 500 mg glucosamine hydrochloride (GLN) and 415 mg chondroitin sulphate (CHN), supplied as a single oral dose twice a day. Out of 84 subjects randomized, 72 subjects who have completed the study were evaluated for the safety and efficacy of the treatments at baseline and subsequent visits (day 28 and 42), by measuring walking performance, VAS, KPS, and WOMAC scores. CGM exhibited 47.02, 21.43, and 206% improvement in VAS, KPS, and walking performance, respectively, compared to the baseline. Similarly, there was 31.17, 32.93, 36.44, and 35% improvement in the pain, stiffness, physical function, and total WOMAC scores. CGM also caused a substantial reduction in the serum inflammatory marker levels. The results indicate that a short-term supplementation of a low dosage CGM exerted superior beneficial effects than a high-dosage CHN-GLN combination in alleviating the pain and symptoms of OA subjects. Further clinical trials of extended duration in a larger population is required to substantiate the efficacy of CGM in the long-term management of OA.
- Published
- 2020
24. Curcumagalactomannoside/Glucosamine Combination Improved Joint Health Among Osteoarthritic Subjects as Compared to Chondroitin Sulfate/Glucosamine: Double-Blinded, Randomized Controlled Study
- Author
-
Ratheesh Mohanan, Thozhuthum Parambil Smina, Aman Khanna, Balu Maliakel, Ajaikumar B. Kunnumakkara, Jestin V Thomas, Sivadasan Syam Das, and Krishnakumar Im
- Subjects
Male ,endocrine system diseases ,Double blinded ,Glucosamine Sulfate ,India ,Osteoarthritis ,Pharmacology ,Severity of Illness Index ,law.invention ,chemistry.chemical_compound ,Curcuma ,Double-Blind Method ,Randomized controlled trial ,law ,Glucosamine ,Humans ,Medicine ,Chondroitin sulfate ,Range of Motion, Articular ,Plant Extracts ,business.industry ,Chondroitin Sulfates ,nutritional and metabolic diseases ,Middle Aged ,medicine.disease ,Treatment Outcome ,Complementary and alternative medicine ,chemistry ,Dietary Supplements ,Curcumin ,Drug Therapy, Combination ,Female ,Phytotherapy ,business - Abstract
Objective: A combination of curcumagalactomannosides (CGM) (400 mg) with glucosamine hydrochloride (GLN) (500 mg) was evaluated against a standard dietary supplement combination chondroitin sulfate...
- Published
- 2020
25. Influence of a Novel Food-Grade Formulation of Red Chili Extract (Capsicum annum) on Overweight Subjects: Randomized, Double-Blinded, Placebo-Controlled Study
- Author
-
Balu Maliakel, Jestin V Thomas, Ratheesh Mohan, Febi John, Krishnakumar I M, Ashil Joseph, and Syam Das Sivadasan
- Subjects
0301 basic medicine ,Pungency ,030109 nutrition & dietetics ,Nutrition and Dietetics ,business.industry ,media_common.quotation_subject ,Placebo-controlled study ,Appetite ,030229 sport sciences ,Overweight ,Placebo ,medicine.disease ,Obesity ,03 medical and health sciences ,0302 clinical medicine ,Animal science ,Tolerability ,Medicine ,Pharmacology (medical) ,medicine.symptom ,business ,Body mass index ,Food Science ,media_common - Abstract
Capsaicinoids from pungent red chilies (Capsicum annum and Capsicum frutescens) have received significant attention as a natural supplement for the management of obesity. However, the consumption of chili extract at physiologically relevant dosage of capsaicinoids is a challenge owing to its pungency and gastrointestinal discomforts. The present study reports the systemic absorption, safety and influence of a novel, food-grade, and sustained-release formulation of capsaicinoids-rich red chili extract using fenugreek dietary fiber (Capsifen®). Twenty-four healthy overweight subjects were randomized into placebo (n = 12) and Capsifen (n = 12) groups and supplemented with 200 mg × 1/day of Capsifen (4 mg capsaicinoids/day) for 28 days. Influence of Capsifen on eating behavior and appetite was followed by Three-Factor Eating Questionnaire (TFEQ) and Council of Nutrition Appetite Questionnaire (CNAQ), respectively. Consumption of Capsifen did not reveal any adverse events or deviations in hematology and biochemical parameters related to safety. However, a significant decrease in body weight (2.1%), w/h ratio (4%) and body mass index (BMI) (2.2%) were observed among Capsifen group when compared to placebo. The TFEQ and appetite analysis revealed a significant improvement in uncontrolled eating and reduction in appetite among Capsifen subjects. The UPLC-ESI-MS/MS analysis confirmed the absorption of capsaicinoids from CAP supplementation. The study further demonstrated the safety and tolerability of Capsifen at the investigational dosage. Thus, the significant reduction in anthropometric parameters such as body weight, w/h ratio, and BMI along with the improvement in eating behaviour as well as appetite, indicated the potential body weight management effect of Capsifen.
- Published
- 2020
26. Amelioration of Radiation-Induced Damages in Mice by Curcuminoids: The Role of Bioavailability
- Author
-
Ramadasan Kuttan, Balu Maliakel, Krishnakumar Im, Angel Thomas, Syam Das Sivadasan, and Vijayasteltar B Liju
- Subjects
Chromosome Aberrations ,0301 basic medicine ,Cancer Research ,Curcumin ,030109 nutrition & dietetics ,Nutrition and Dietetics ,Chemistry ,Biological Availability ,Medicine (miscellaneous) ,Radiation-Protective Agents ,Radiation induced ,Pharmacology ,Bioavailability ,Mice ,03 medical and health sciences ,0302 clinical medicine ,Oncology ,Diarylheptanoids ,030220 oncology & carcinogenesis ,parasitic diseases ,Animals ,DNA Damage - Abstract
The present study investigated the role of free curcuminoids bioavailability on the relative radioprotective efficacy of natural unformulated curcuminoids.A food-grade bioavailable formulation of curcuminoids as curcumagalactomannosides (CGM) and unformulated curcuminoids (UC) were employed for the study. Swiss albino mice were randomized into Normal control, Radiation control, Radiation + UC, and Radiation + CGM groups and irradiated with γ-radiation of 6, 8, 10 and 12 Gy. Survival rate, hematological and biochemical parameters, bone marrow cellularity, chromosomal aberrations and histopathology of intestine were followed as a measure of the relative efficacy.The present study demonstrated the positive role of the bioavailability of curcuminoids in the amelioration of radiation-induced damages in mice since CGM treatment exerted better survival rate and radioprotective effect as compared with UC, despite the relatively low concentrations of curcuminoids in CGM (39% w/w).
- Published
- 2020
27. Safety assessment of a fenugreek dietary fiber-based formulation of capsaicinoids-rich red chili (Capsicum annum) extract (Capsifen®): Acute and sub-chronic studies
- Author
-
Suresh Kumar, Balu Maliakel, Johannah Nm, Krishnakumar Im, Ashil Joseph, and Syam Das S
- Subjects
medicine.medical_specialty ,Health, Toxicology and Mutagenesis ,Urine ,010501 environmental sciences ,Biology ,Toxicology ,01 natural sciences ,Capsifen ,03 medical and health sciences ,Galactomannan ,chemistry.chemical_compound ,0302 clinical medicine ,food ,lcsh:RA1190-1270 ,medicine ,Red chili pepper ,Adverse effect ,0105 earth and related environmental sciences ,lcsh:Toxicology. Poisons ,Pungency ,Traditional medicine ,Stomach ,food and beverages ,Regular Article ,food.food ,Cayenne pepper ,Capsicum annum ,medicine.anatomical_structure ,chemistry ,Toxicity ,Histopathology ,Fenugreek dietary fiber ,Safety ,Sustained-release ,030217 neurology & neurosurgery - Abstract
Despite the promising health beneficial effects (thermogenic, lipolytic, hypotriglyceridemic, hypocholesterolemic, anti-inflammatory and anticancer) of capsaicinoids-rich red chili pepper, commonly known as cayenne pepper (Capsicum annum or Capsicum frutescence), its consumption at physiologically relevant dosage is always hampered by the pungency and stomach discomforts. The present study examined the safety of a pungency-masked and sustained release food-grade formulation of capsaicinoids-rich red chili pepper extract using fenugreek derived galactomannan soluble dietary fiber (Capsifen®). The safety was assessed by oral acute (300, 2000, 5000 mg/kg b. wt. for 14 days) and subchronic (250, 500 and 1000 mg/kg b. wt.) toxicity studies in Wistar rats. None of the group of animals belonging to both acute and subchronic treatments did produce any adverse events in feeding behavior, urine analysis, and in hematology/biochemical parameters when compared to the control. However, a decrease in body weight was observed among 500 and 1000 mg/kg b. wt. treated groups. The terminal autopsy did not reveal any alterations in relative organ weight except for the high dose treated group, where an increase in liver and kidney weight was observed. Histopathology of all the animals was normal. Thus, the Low-observed-adverse-effect level (LOAEL) of Capsifen was determined for 500 mg/kg b. wt. /day.
- Published
- 2020
28. Enhanced bioavailability and pharmacokinetics of a novel hybrid-hydrogel formulation of fisetin orally administered in healthy individuals: a randomised double-blinded comparative crossover study
- Author
-
Illathu Madhavamenon Krishnakumar, Asha Jaja-Chimedza, Ashil Joseph, Abhilash Balakrishnan, Balu Maliakel, and Andrew Swick
- Subjects
Nutrition and Dietetics ,Cross-Over Studies ,Flavonols ,Endocrinology, Diabetes and Metabolism ,Biological Availability ,Hydrogels ,Food Science - Abstract
Fisetin, a polyphenol found in several fruits and vegetables, has shown potential health benefits in many pre-clinical studies for neuroprotection, cardioprotection, chemoprevention, diabetes, inflammation and oxidative stress. However, the clinical effectiveness of fisetin may be limited by its poor bioavailability when ingested. Using a novel green technology of Hybrid-FENUMAT™, a food-grade fisetin formulation (FF-20) was developed through encapsulation of fisetin micelles into fenugreek galactomannan (FG) hydrogel scaffold to improve its physical characteristics and bioavailability. This is the first human pharmacokinetic study of fisetin following a single-dose, comparative, double-blinded, cross-over protocol, supplementing with FF-20 and unformulated fisetin (UF). Fifteen healthy volunteers were given a single dose of 1000 mg UF or 1000 mg FF-20 (delivering 192 mg fisetin) with a 10-d washout period between each dose. Blood samples were taken at 0⋅5, 1, 2, 3, 5, 8 and 12 h after both days of supplementation to quantify fisetin and geraldol, an active metabolite. The plasma concentration of fisetin when individuals consumed FF-20 was 26⋅9-fold greater than UF as determined by the area under the curve over 12 h [AUC0–12 h (FF-20) = 341⋅4 v. AUC0–12 h (UF) = 12⋅67]. The maximum plasma concentration (Cmax) was also more than twenty-three times higher when supplemented with FF-20 (238⋅2 ng/ml) compared to UF (9⋅97 ng/ml). The encapsulation also reduced the amount of conversion of fisetin to geraldol. No adverse events were reported during the study. Therefore, the encapsulation of fisetin into FG dietary fibre hydrogel scaffold could improve its delivery and bioavailability in human subjects.
- Published
- 2021
29. Enhanced absorption of curcuminoids and 3-Acetyl-11-keto-β-boswellic acid from fenugreek galactomannan hydrogel beadlets: A natural approach to the co-delivery of lipophilic phytonutrients
- Author
-
Vynckier An-Katrien, Van Den Driessche Mieke, Baby Chakrapani Ps, Dinesh Kumar, Krishnakumar Illathu Madhavamenon, Balu Maliakel, Syam Das Sivadasan, Vanheule Greet, Ayswaria Deepti, Aswathi Nair, and Maliakkal Balakrishnan Abhilash
- Subjects
0301 basic medicine ,Bioavailability ,Medicine (miscellaneous) ,Absorption (skin) ,03 medical and health sciences ,Galactomannan ,chemistry.chemical_compound ,0404 agricultural biotechnology ,Pharmacokinetics ,Curcuminoids ,TX341-641 ,Co delivery ,030109 nutrition & dietetics ,Nutrition and Dietetics ,Chromatography ,Chemistry ,Nutrition. Foods and food supply ,Co-delivery ,04 agricultural and veterinary sciences ,040401 food science ,Boswellic acids ,Colloidal particle ,Hydrogel, Self-emulsifying beadlets ,Boswellic acid ,Fenugreek dietary fiber ,Enhanced absorption ,Food Science - Abstract
Simultaneous oral delivery of bioactive molecules with enhanced bioavailability is of great significance, especially when delivered from single beadlets. Here, we report the formulation, characterization, and pharmacokinetic properties of two poorly bioavailable lipophilic phytonutrients with synergistic effects, curcuminoids and 3-Acetyl-11-keto-β-boswellic acid (AKBA), following their co-delivery using fenugreek dietary fiber (Galactomannans)-based hydrogel beadlets (CGM-BSW). These beadlets are capable of extensive swelling and sustained-release of self-emulsified colloidal particles (150 – 200 nm) containing curcuminoids and AKBA allowing for improved absorption. The results of our double-blinded 4-way crossover, 4-sequence study (n = 14) demonstrated that a single dose of 250 mg of these beadlets enhanced the absorption of unconjugated curcuminoids (24.8-fold) and AKBA (6.9-fold) compared to their unformulated counterparts. The absorption of CGM-BSW formulated curcuminoids was also 5.6-fold higher than that of those formulated with turmerones (UCT). UPLC-ESI-QQQ-MS/MS was used to quantify both the curcuminoids and AKBA concentration in the plasma samples and this data was used to determine their pharmacokinetic characteristics.
- Published
- 2021
30. Brain regional pharmacokinetics following the oral administration of curcumagalactomannosides and its relation to cognitive function.
- Author
-
Kannan, Ramalingam G., Abhilash, Maliakal B., Dinesh, Kumar, Syam, Das S., Balu, Maliakel, Sibi, Ittiyavirah, and Krishnakumar, I. M.
- Subjects
ORAL drug administration ,COGNITIVE ability ,PHARMACOKINETICS ,MASS spectrometry ,CEREBRAL cortex ,HIPPOCAMPUS (Brain) ,BRAIN stem - Abstract
Though a number of bioavailable formulations of curcuminoids have been reported and available commercially as nutraceuticals for brain health, systematic informations on their blood–brain-barrier permeability and brain tissue distribution have not been reported. The present study was aimed to investigate the brain regional pharmacokinetics of curcuminoids following both single dose and repeated dose oral administration of a self-emulsifying food-grade formulation of curcuminoids using fenugreek galactomannan hydrogel scaffold as 'curcumagalactomannosides' (CGM), and its influence on cognitive functions in comparison with unformulated natural curcuminoids (NC) in Wistar rats. CGM was given to animals in single dose (100 mg curcuminoids/kg b. wt.) and repeated dose (100 mg curcuminoids/kg b. wt. for 28 days) and the concentration of total curcuminoids at various parts of brain was evaluated at different time points using Ultra-performance liquid chromatography/electrospray ionization triple quadruple tandem mass spectroscopy (UPLC-ESI-MS/MS) system. Another set of animals were also fed with CGM at single dose (100 mg curcuminoids/kg b. wt.) and repeated dose (100 mg curcuminoids/kg b. wt. for 28 days) and the behavioural studies were conducted using open field test and radial arm maze. UPLC-ESI-MS/MS analyses of plasma revealed significant absorption of unconjugated (free) curcuminoids upon both single and repeated dose administration of CGM with maximum concentrations of 173.34 ± 27.12 ng/mL and 223.22 ± 32.73 ng/mL, respectively. Further analysis of brain tissues demonstrated significant blood–brain-barrier permeability. Brain regional pharmacokinetics (AUC, C
max and t1/2 ) indicated a relative distribution order of hippocampus > striatum > cerebellum > cerebral cortex > brain stem. Supplementation of CGM for 28 days also offered significant (p < 0.05) improvement in locomotor activity and reduction in spatial memory errors as compared to NC. The NC treatment also improved the behaviour better than the vehicle-treated group. CGM could distribute significant amount of free curcuminoids, in brain especially in the hippocampus at both single and repeated dose administration with an elimination half-life of 2.6 h. CGM also showed a positive impact in behaviour of animals in comparison with normal unformulated curcuminoids. [ABSTRACT FROM AUTHOR]- Published
- 2022
- Full Text
- View/download PDF
31. The effects of oral administration of curcumin-galactomannan complex on brain waves are consistent with brain penetration: a randomized, double-blinded, placebo-controlled pilot study
- Author
-
Andrew G Swick, Kannan R, Balu Maliakel, Aman Khanna, Cristina Matthewman, Krishnakumar Im, Sibi P Ittiyavirah, and Syam Das S
- Subjects
0301 basic medicine ,Curcumin ,endocrine system diseases ,Double blinded ,Medicine (miscellaneous) ,Administration, Oral ,Pilot Projects ,Pharmacology ,Brain waves ,Placebo ,Mannans ,03 medical and health sciences ,chemistry.chemical_compound ,Galactomannan ,0302 clinical medicine ,Double-Blind Method ,Oral administration ,Medicine ,Animals ,Humans ,030109 nutrition & dietetics ,Nutrition and Dietetics ,business.industry ,General Neuroscience ,Brain ,Galactose ,General Medicine ,Penetration (firestop) ,Brain Waves ,Bioavailability ,chemistry ,business ,030217 neurology & neurosurgery - Abstract
A novel highly bioavailable curcumin-galactomannan (CGM) formulation was shown to have improved blood-brain-barrier (BBB) permeability of free curcuminoids in animal models; however, this has not been established in humans. The present study was conducted to determine the functional effects of CGM on brain waves in healthy individuals, owing to its BBB permeability.A total of 18 healthy volunteers aged 35-65 were randomly assigned to consume 500 mg CGM, Unformulated curcumin (UC) or Placebo capsules twice daily for 30 days. Electroencephalogram (EEG) measurements, audio-visual reaction time tests and a working memory test were conducted at baseline and after 30 days.Supplementation of CGM resulted in a significant increase in α- and β-waves (The observed increase in α and β waves and reduction in
- Published
- 2020
32. Thymoquinone-rich black cumin oil improves sleep quality, alleviates anxiety/stress on healthy subjects with sleep disturbances– A pilot polysomnography study
- Author
-
Baby Chakrapany Ps, Balu Maliakel, Kannan R, Krishnakumar Im, Syam Das S, Sibi P Ittiyavirah, and Sanju George
- Subjects
medicine.medical_specialty ,medicine.diagnostic_test ,business.industry ,Rapid eye movement sleep ,Polysomnography ,Sleep in non-human animals ,Non-rapid eye movement sleep ,Clinical trial ,Complementary and alternative medicine ,medicine ,Insomnia ,Physical therapy ,Anxiety ,medicine.symptom ,business ,Depression (differential diagnoses) - Abstract
Introduction Insomnia, the inability to get sleep or sleep well at night, is a universal health problem. In the present single-arm, open-label, pilot study, the safety and efficacy of a thymoquinone-rich (5% w/w) black cumin oil (Nigella sativa) (BCO) was investigated for the first time, among healthy subjects characterized with significant sleep problems. Methods Fifteen subjects were selected for the study and were provided with softgel capsules of BCO (200 mg × 1/day, after dinner) for 28 days. Polysomnographic analysis was performed to assess sleep quality, sleep efficiency and sleep latency (primary outcomes) at the beginning (visit 2) and after 7 days of supplementation (visit 3). Sleep quality index, anxiety and stress (secondary outcomes) were also measured at the beginning and at the end of the study period using the validated questionnaires PSQI, Depression Anxiety Stress Scale -21 (DASS-21) and Hamilton Anxiety Rating Scale-A (HAM-A), along with cortisol and safety parameters. Results The results suggested a significant improvement in primary outcomes such as total sleep time, sleep latency and sleep efficiency with an increase of 82.49 % in Non-Rapid Eye Movement (NREM 3) and 29.38 % increase in rapid eye movement sleep (REM sleep). The secondary outcome measurements also showed a significant reduction (P Conclusion Supplementation of BCO was safe and found to significantly improve the sleep quality and ameliorate stress and anxiety. [Clinical Trial Reg No: CTRI/2018/03/012,391 dated 07/03/2018]
- Published
- 2022
33. Brain regional pharmacokinetics following the oral administration of curcumagalactomannosides and its relation to cognitive function
- Author
-
Kannan, Ramalingam G., primary, Abhilash, Maliakal B., additional, Dinesh, Kumar, additional, Syam, Das S., additional, Balu, Maliakel, additional, Sibi, Ittiyavirah, additional, and Krishnakumar, I. M., additional
- Published
- 2021
- Full Text
- View/download PDF
34. Influence of a Novel Food-Grade Formulation of Red Chili Extract (
- Author
-
Ashil, Joseph MSc, Febi, John PhD, Jestin V, Thomas MSc, Syam Das PhD, Sivadasan, Balu, Maliakel PhD, Ratheesh, Mohan PhD, and Krishnakumar, I M
- Subjects
Plant Extracts ,Tandem Mass Spectrometry ,Delayed-Action Preparations ,Fruit ,Dietary Supplements ,Appetite ,Humans ,Feeding Behavior ,Overweight ,Capsicum - Abstract
Capsaicinoids from pungent red chilies (
- Published
- 2020
35. Efficacy of a novel extract of fenugreek seeds in alleviating vasomotor symptoms and depression in perimenopausal women: A randomized, double-blinded, placebo-controlled study
- Author
-
Jyoti Rao, Krishnakumar Im, Balu Maliakel, Aman Khanna, S. Syam Das, Febi John, and Jestin V Thomas
- Subjects
030309 nutrition & dietetics ,Osteoporosis ,Biophysics ,Placebo-controlled study ,Physiology ,Placebo ,03 medical and health sciences ,0404 agricultural biotechnology ,Sex hormone-binding globulin ,Double-Blind Method ,Diabetes mellitus ,medicine ,Humans ,Adverse effect ,Pharmacology ,0303 health sciences ,biology ,Vasomotor ,business.industry ,Depression ,Plant Extracts ,04 agricultural and veterinary sciences ,Cell Biology ,medicine.disease ,040401 food science ,Perimenopause ,Trigonella ,Hot Flashes ,biology.protein ,Female ,Sexual function ,business ,Food Science - Abstract
The present randomized, double-blinded, placebo-controlled study investigated the effect of a standardized fenugreek extract (FHE) on perimenopausal discomforts and its influence on hormonal balance and safety. Healthy women characterized with perimenopausal symptoms (n = 48), as assessed by MRS questionnaire, were randomized either to FHE (n = 24) or placebo (n = 24) and supplemented with 250 mg × 2/day for 42 days. Both inter and intra-group comparison revealed a significant improvement in somatic, psychological, and urogenital scores in FHE group, especially for hot flashes (25.9%), night sweats (26.5%), depression (31.8%), and insomnia (21.6%). Further hormone analysis revealed an enhancement in serum estradiol (18.9%), free testosterone (38.2%), and progesterone (19.9%) concentrations and a significant decrease in FSH (38.2%) and SHBG (21.1%) concentrations toward establishing a hormonal balance among FHE-group; without significant changes in other clinical safety parameters. Thus, FHE supplementation offered a significant reduction in vasomotor effects and depression in perimenopausal women, without any adverse effects PRACTICAL APPLICATIONS: Fenugreek is a popular kitchen spice and Ayurvedic medicine for a variety of health conditions including diabetes, hypercholesterolemia, hepatotoxicity, gastritis, and also for a variety of hormone-related health conditions such as sexual functions, lactation, osteoporosis, PCOS, and post/perimenopausal discomforts. Fenugreek is rich in alkaloids, steroidal saponins, flavonoids and 4-hydroxyisoleucine. The present randomized-controlled study investigated the plausible application of a standardized hydro-ethanolic extract of fenugreek seeds (FHE) having a unique 3:1 ratio for protodioscin to trigonelline in the management of perimenopausal discomforts. It was observed that FHE at a dosage of 250 mg × 2/day for 42 days significantly reduced the discomforts, especially vasomotor symptoms and depression, and helped to attain a hormonal balance without any adverse effects or deviations in clinical safety parameters. Thus, FHE could be a potential natural agent for the management of post and perimenopausal discomforts and has to be explored in future studies.
- Published
- 2020
36. Clove Bud Polyphenols Alleviate Alterations in Inflammation and Oxidative Stress Markers Associated with Binge Drinking: A Randomized Double-Blinded Placebo-Controlled Crossover Study
- Author
-
Renny R. Mammen, Krishnakumar Illathu Madhavamenon, Balu Maliakel, Johannah Natinga Mulakal, and Ratheesh Mohanan
- Subjects
Adult ,Male ,0301 basic medicine ,Syzygium ,education ,Medicine (miscellaneous) ,Binge drinking ,Alcohol ,Inflammation ,Acetaldehyde ,Flowers ,Pharmacology ,Placebo ,medicine.disease_cause ,Binge Drinking ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Double-Blind Method ,mental disorders ,medicine ,Humans ,Liver injury ,Cross-Over Studies ,Nutrition and Dietetics ,Interleukin-6 ,Plant Extracts ,Superoxide Dismutase ,business.industry ,Polyphenols ,Middle Aged ,medicine.disease ,Glutathione ,Crossover study ,Oxidative Stress ,030104 developmental biology ,chemistry ,Female ,030211 gastroenterology & hepatology ,Lipid Peroxidation ,medicine.symptom ,business ,Biomarkers ,Oxidative stress - Abstract
Acetaldehyde, the major cytotoxin formed by the metabolism of alcohol, is responsible for liver injury, extracellular matrix alterations, inflammation, and hangover in heavy drinkers. This study aimed to demonstrate the efficacy of a standardized polyphenolic extract of clove buds (Clovinol) in ameliorating the oxidative stress and inflammation caused by the accumulation of acetaldehyde after binge drinking. We used a randomized, double-blinded crossover study with 16 male social drinkers. The subjects were randomized into two groups of eight subjects and received either placebo or Clovinol in a single hard shell gelatin capsule (250 mg × 1) per day. The dosage of alcohol was 1 g/kg body weight/day. After 2 weeks of washout period, the treatment regime was reversed. Blood samples were drawn at 0, 0.5, 2, 4, and 12 h after treatment with either placebo or Clovinol, and biochemical parameters were analyzed. Hangover severity score was determined by using a validated questionnaire as reported earlier. Results showed faster elimination of blood acetaldehyde with significant decreases in oxidative stress, lipid peroxidation, C-reactive protein, interleukin-6, and significant enhancement in glutathione and superoxide dismutase as compared with placebo along with an overall reduction of 55.34% in hangover severity in Clovinol-treated subjects. This study demonstrated the efficacy of clove bud polyphenols for alleviating alcohol-related side effects among social drinkers at the studied dose.
- Published
- 2018
37. A green approach for the sustained-intestinal delivery of red chili (Capsicum annum L) extracted capsaicinoids with enhanced bioavailability
- Author
-
Krishnakumar Illathu Madhavamenon, Johannah Natinga Mulakal, Syam Das Sivadasan, Ashil Joseph, Ratheesh Mohan, Balu Maliakel, and Abhilash Maliakkal Balakrishnan
- Subjects
Medicine (miscellaneous) ,Beadlets ,medicine.disease_cause ,Capsifen ,Galactomannan ,chemistry.chemical_compound ,Granulation ,Gastric mucosa ,medicine ,TX341-641 ,Food science ,Nutrition and Dietetics ,Nutrition. Foods and food supply ,Chemistry ,Capsicum annum L ,Enhanced bioavailability ,Hydrogel ,medicine.anatomical_structure ,Plasma concentration ,Fenugreek dietary fiber ,Capsaicin ,Swelling ,medicine.symptom ,Irritation ,Food Science ,Homogenization (biology) - Abstract
Intestinal delivery with enhanced bioavailability is of great significance for stomach irritating and pungent bioactive molecules. The present study reports the development of a pungency-masked food-grade microbeadlets for the sustained-intestinal delivery of red chili extracted capsaicinoids using fenugreek galactomannans. Capsaicinoids encapsulated microbeads (CapF) of about 250 to 400 µm were prepared by a gel-phase homogenization, fluid-bed granulation followed by galactomannan coating, and characterized by NMR, FTIR, DSC, PXRD, and SEM as stable, directly compressible, free flowing amorphous beadlets with a tap density of 0.64 ± 0.2 g/mL. Swelling studies, in vitro release kinetics and particle size analysis indicated the intestinal delivery of soluble capsaicinoids. Pharmacokinetic studies on Wistar rats revealed enhanced bioavailability (19-fold) of CapF when the area under plasma concentration verses time was compared with that of unformulated capsaicinoids. CapF was safe upon gastric mucosa irritation test and demonstrated significant (P
- Published
- 2021
38. Beyond the flavor: A green formulation of Ferula asafoetida oleo-gum-resin with fenugreek dietary fibre and its gut health potential
- Author
-
I.J. Jismy, Ashil Joseph, Ramadasan Kuttan, Liju Vijayasteltar, Krishnakumar Im, and Balu Maliakel
- Subjects
0301 basic medicine ,Taste ,Chemistry ,Health, Toxicology and Mutagenesis ,Dietary fibre ,Toxicology ,Acute toxicity ,03 medical and health sciences ,Galactomannan ,chemistry.chemical_compound ,030104 developmental biology ,Biochemistry ,Odor ,lcsh:RA1190-1270 ,Toxicity ,Food science ,Flavor ,Paw edema ,lcsh:Toxicology. Poisons - Abstract
Albeit the fact that asafotida is a popular kitchen spice and Indian folklore medicine for gut disorders, its consumption at physiologically relevant dosage is greatly challenged by the unpleasant flavor characteristics. Herein we report a green approach to derive stable powder formulations of asafoetida gum with minimized taste and odor suitable for dietary applications and gut health-related disorders. Employing a water based ultrasound mediated gel-phase dispersion of asafoetida gum on fenugreek derived soluble galactomannan fibre matrix. Microencapsulated particles (1 ± 0.3 μm) of asafoetida was prepared as water dispersible free flowing powder (Asafin). Fourier-transform infrared spectroscopy (FTIR), scanning electron microscopy (SEM), accelerated stability and in vitro dissolution studies confirmed the stability, sustained release and microencapsulated structure of Asafin. Further investigations revealed significant (pÂ
- Published
- 2017
39. Comparative neuroprotective effects of native curcumin and its galactomannoside formulation in carbofuran-induced neurotoxicity model
- Author
-
Ramadasan Kuttan, Saritha S. Nair, Krishnakumar I. M., Balu Maliakel, Binitha P. P, and Sindhu E. R.
- Subjects
Male ,medicine.medical_specialty ,Curcumin ,endocrine system diseases ,Biological Availability ,Plant Science ,Pharmacology ,medicine.disease_cause ,01 natural sciences ,Biochemistry ,Neuroprotection ,Analytical Chemistry ,Mannans ,Rats, Sprague-Dawley ,chemistry.chemical_compound ,Carbofuran ,Medicine ,Animals ,Pesticides ,Behavior, Animal ,010405 organic chemistry ,business.industry ,Organic Chemistry ,Neurotoxicity ,nutritional and metabolic diseases ,Brain ,Galactose ,medicine.disease ,0104 chemical sciences ,Bioavailability ,Mitochondria ,010404 medicinal & biomolecular chemistry ,Oxidative Stress ,Neuroprotective Agents ,chemistry ,Liver ,Toxicity ,Acetylcholinesterase ,Histopathology ,Neurotoxicity Syndromes ,business ,Oxidative stress - Abstract
Toxicity of the pesticide carbofuran (CF) can be alleviated by curcumin, if not for its poor bioavailability. Hence, we investigated the effect of a bioavailable curcumin-galactomannan complex (CGM) on CF-induced neurotoxicity in rats in comparison to that of unformulated standard curcumin (CS). The CF (5 mg/kg b.wt/day) treatment for 90 days produced chronicity model which were treated with either CS or CGM (100 mg/kg b.wt and 250 mg/kg b.wt/day) for another 30 days. Improvement in CF-induced behaviour was evident in endurance, motor co-ordination and pain response on both CS (p
- Published
- 2018
40. Phytoestrogenic effect of fenugreek seed extract helps in ameliorating the leg pain and vasomotor symptoms in postmenopausal women: A randomized, double-blinded, placebo-controlled study
- Author
-
Aman Khanna, Jyoti Rao, Jestin V Thomas, Shamshad Begum, Febi John, Krishnakumar Im, and Balu Maliakel
- Subjects
0301 basic medicine ,Pharmacology ,030109 nutrition & dietetics ,Vasomotor ,biology ,Genitourinary system ,business.industry ,Placebo-controlled study ,Physiology ,Irritability ,Placebo ,03 medical and health sciences ,0302 clinical medicine ,Sex hormone-binding globulin ,medicine ,biology.protein ,Pharmacology (medical) ,medicine.symptom ,business ,030217 neurology & neurosurgery ,Food Science ,Hormone ,Balance (ability) - Abstract
Background Fenugreek is a popular spice which has been evaluated for hormone related disorders. Methods The present randomized, double-blinded, placebo-controlled study investigated the effect of a unique extract of fenugreek (FHE), at a dose of 250 mg × 2/day for 42 days on hormone balance and postmenopausal discomforts. Postmenopausal women (n = 48) having characteristic postmenopausal symptoms, as assessed by MRS questionnaire, were randomized either to FHE (n = 24) or placebo (n = 24) groups. Results The FHE-treated participants reported the feel of well-being within two weeks of supplementation and further improvement was observed in somatic, psychological and urogenital scores towards the end of the study period. There were 2.9, 4.2 and 7.2 times reduction respectively in hot flashes, night sweats and pain on leg muscles and joints with significant improvement in irritability and vaginal dryness when compared to placebo. Hormone analysis revealed significant increase in estradiol, free testosterone, progesterone and decrease in FSH, SHBG and CTX-1 concentrations, though within the safe range, indicating the trend towards attaining a hormonal balance. Conclusion Supplementation of FHE regulated various hormones in postmenopausal women and offered a significant reduction in vasomotor effects and leg pain without showing any significant variations in hematological and biochemical parameters.
- Published
- 2020
41. Enhanced bioavailability and relative distribution of free (unconjugated) curcuminoids following the oral administration of a food-grade formulation with fenugreek dietary fibre: A randomised double-blind crossover study
- Author
-
Krishnakumar Im, Subash Ps, Della Jacob, Balu Maliakel, Abhilash Maliakkal, Veera Konda, Ramadassan Kuttan, Dinesh Kumar, and Johannah Nm
- Subjects
Curcumin ,Membrane permeability ,Bioavailability ,Medicine (miscellaneous) ,Pharmacology ,030226 pharmacology & pharmacy ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Pharmacokinetics ,Oral administration ,Curcuminglucuronide ,Enzymatic hydrolysis ,Distribution (pharmacology) ,TX341-641 ,Nutrition and Dietetics ,Nutrition. Foods and food supply ,Crossover study ,Conjugated curcumin metabolites ,chemistry ,030220 oncology & carcinogenesis ,Food Science - Abstract
Despite the various reports on enhanced bioavailable formulations of curcumin, systemic oral bioavailability of unconjugated curcuminoids remains a challenge. Considering the differences in plasma bioactivity and membrane permeability of free curcuminoids over conjugated metabolites, herein we report a randomised double-blinded crossover study (n = 50) to investigate the relative bioavailability and pharmacokinetics of free curcuminoids following the oral administration of high (1000 mg) and low (250 mg) doses of a food-grade formulation of curcumin with fenugreek dietary fibre as curcumagalactomannosides (CGM), which was reported to exhibit improved blood-brain – barrier permeability in rats. CGM administration provided over 45.5-fold enhancement in free curcuminoids bioavailability with improved pharmacokinetics when compared to unformulated standard curcumin. Further investigations with and without enzymatic hydrolysis of plasma collected over 5 h post-administration of CGM at 1000 mg dose revealed higher free curcuminoids in plasma (74 ± 8%) as compared to conjugated curcuminoids (26 ± 12%) indicating a significant distribution of free curcuminoids over conjugated curcumin metabolites.
- Published
- 2016
42. Safety and influence of a novel powder form of coconut inflorescence sap on glycemic index and lipid profile
- Author
-
Febi John, Ratheesh Mohanan, Krishnakumar Im, Balu Maliakel, Renny R. Mammen, and Bradley S. Fleenor
- Subjects
0303 health sciences ,medicine.diagnostic_test ,Glycogen ,030309 nutrition & dietetics ,business.industry ,Organic Chemistry ,Blood sugar ,04 agricultural and veterinary sciences ,Micronutrient ,040401 food science ,Biochemistry ,03 medical and health sciences ,chemistry.chemical_compound ,0404 agricultural biotechnology ,Blood pressure ,Glycemic index ,Postprandial ,chemistry ,parasitic diseases ,medicine ,Food science ,Lipid profile ,business ,Food Science ,Glycemic - Abstract
Carbohydrates are the primary source of energy for human body. Carbohydrates increase resting muscle glycogen levels and help in delaying muscle fatigue. But, higher intake of high glycemic carbohydrates may lead to complications, if not balanced by physical activities. Our earlier studies have indicated that a proprietary powder preparation of coconut inflorescence sap (COCOZEN™, abbreviated as ‘CSP’ meaning ‘coconut sap powder’) contains relatively higher levels of micronutrients and possess antioxidant, anti-inflammatory, nephroprotective, hepatoprotective, gastroprotective and ergogenic activities. Thus, the present study was aimed to investigate the safety and efficacy of CSP (15 g/day for 90 days) on healthy and nonathletic subjects (n = 20). The study was performed in two phases. In the first phase, glycemic index (GI) was measured using glucose as a reference standard. In the second phase, CSP was supplemented at (15g × 1)/day dosage for 90 days and monitored the anthropometric parameters, adverse events, blood sugar levels (fasting and postprandial), blood pressure, and other routine hematological and biochemical parameters. It was observed that CSP possess a GI of 52.47 and is safe with an acceptable sensory attribute. It did not contribute any side effects or deviations in blood sugar or other hematological and biochemical parameters, except in Hb and lipid profile which showed significant (p
- Published
- 2020
43. Safety and Efficacy of
- Author
-
K N, Mala, Jestin, Thomas, Das S, Syam, Balu, Maliakel, and I M, Krishnakumar
- Abstract
Despite the availability of various synthetic drugs for the treatment of functional dyspepsia (FD), the side effects and their cost have always created a great interest in the search for novel natural alternatives for the management of gut disorders. The present contribution reports the safety and efficacy of the kitchen spice asafoetida (
- Published
- 2018
44. Safety and Efficacy of Ferula asafoetida in Functional Dyspepsia: A Randomized, Double-Blinded, Placebo-Controlled Study
- Author
-
Krishnakumar Im, Balu Maliakel, Das S. Syam, Jestin V Thomas, and K. N. Mala
- Subjects
medicine.medical_specialty ,biology ,Article Subject ,business.industry ,Placebo-controlled study ,lcsh:Other systems of medicine ,lcsh:RZ201-999 ,biology.organism_classification ,Placebo ,medicine.disease ,Gastroenterology ,03 medical and health sciences ,0302 clinical medicine ,Bloating ,Postprandial ,Motion sickness ,Complementary and alternative medicine ,Quality of life ,030220 oncology & carcinogenesis ,Internal medicine ,Medicine ,030211 gastroenterology & hepatology ,business ,Adverse effect ,Ferula - Abstract
Despite the availability of various synthetic drugs for the treatment of functional dyspepsia (FD), the side effects and their cost have always created a great interest in the search for novel natural alternatives for the management of gut disorders. The present contribution reports the safety and efficacy of the kitchen spice asafoetida (Ferula asafoetida) in FD for the first time. In the double-blinded, placebo-controlled study, 43 subjects diagnosed to have moderate to severe discomforts of nonulcer FD were randomized to receive hard-shell capsules (250 mg × 2/day) of either placebo (n=22) or a food-grade formulation of asafoetida (Asafin) (n=21) for 30 days. When evaluated by a set of validated indexing tools (GSRS, GDSS, and NDI), almost 81% in the Asafin group showed significant (p < 0.01) improvement in the overall score and quality of life as compared to the placebo. At the end of the study, 66% of subjects in the Asafin group remained symptoms-free. Although the symptoms score improved significantly in both the groups (from -5.67 to -25.29 in Asafin group versus -1.55 to -6.0 in the placebo; p ≤ 0.001), the relative percentage of subjects in the Asafin group with more than 80% reduction in various symptoms were: bloating (58%), appetite (69%), postprandial fullness (74%) motion sickness (75%), and digestion (77%) as compared to less than 10% nonspecific improvement in the placebo group. All the subjects remained safe with no adverse events or variations in haematological and biochemical parameters. The study was registered at http://ctri.nic.in/ (CTRI/2018/ 01/011149).
- Published
- 2018
- Full Text
- View/download PDF
45. A Novel Curcumin-Galactomannoside Complex Delivery System Improves Hepatic Function Markers in Chronic Alcoholics: A Double-Blinded, randomized, Placebo-Controlled Study
- Author
-
Jestin V Thomas, Naveen T. Krishnareddy, Krishnakumar Im, Balu Maliakel, Johannah Natinga Mulakal, and Saritha S. Nair
- Subjects
0301 basic medicine ,Adult ,Male ,medicine.medical_specialty ,Curcumin ,Article Subject ,Placebo-controlled study ,lcsh:Medicine ,Inflammation ,medicine.disease_cause ,Placebo ,Gastroenterology ,General Biochemistry, Genetics and Molecular Biology ,law.invention ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Drug Delivery Systems ,Randomized controlled trial ,Double-Blind Method ,law ,Internal medicine ,medicine ,Humans ,Transaminases ,General Immunology and Microbiology ,business.industry ,lcsh:R ,General Medicine ,gamma-Glutamyltransferase ,Middle Aged ,Alcoholism ,030104 developmental biology ,chemistry ,Liver ,030220 oncology & carcinogenesis ,Chronic Disease ,Clinical Study ,Delivery system ,Liver function ,medicine.symptom ,business ,Corrigendum ,Oxidative stress ,Biomarkers - Abstract
Considering the recent interest in free (unconjugated) curcuminoids delivery, the present study investigated the efficacy of a novel food-grade free-curcuminoids delivery system (curcumin-galactomannoside complex; CGM) in improving the hepatic function markers (inflammation and oxidative stress) in chronic alcoholics. The double-blinded, placebo-controlled study randomized 48 subjects with elevated serum transaminases and gamma-glutamyl transferase (GGT) levels, who were allocated to two groups (n=24) and to receive either placebo or CGM at (250 mg × 2)/day for 8 weeks. While liver function markers (transaminases and GGT) in the placebo group showed an increase (~ 9.5%), CGM group indicated a significant decrease in transaminases (31%) and GGT (29%) from the baseline levels. The beneficial effect of CGM was also clear from the significant increase (p CTRI/2018/03/012385.
- Published
- 2018
46. Dietary addition of a standardized extract of turmeric (TurmaFEED
- Author
-
Johannah, Nm, Ashil, Joseph, Balu, Maliakel, and Krishnakumar, Im
- Subjects
Phytogenics ,Antioxidant activity ,Research ,Broiler ,Turmeric ,Carcass traits ,Growth promoter - Abstract
Background Indiscriminate use of antibiotics in livestock and poultry farming has caused emergence of new pathogenic strains. The situation has warrented the development of safe and alternative growth promoters and immunity enhancers in livestock. Herbal additives in animal and bird feed is a centuries-old practice. Thus, the present study investigated the efficacy of a standardized formulation of lipophilic turmeric extract containing curcumin and turmerones, (TF-36), as a natural growth promoter poultry feed additive. Methods The study was designed on 180 one-day old chicks, assigned into three groups. Control group (T0) kept on basal diet and supplemented groups T0.5 and T1 fed with 0.5% and 1% TF-36 fortified basal diet for 42 days. Each dietary group consisted of six replicates of ten birds. Body weight, food intake, food conversion ratio, skin colour, blood biochemical analysis and antioxidant status of serum were investigated. Results Body weight improved significantly in T1 with a 10% decrease in FCR as compared to the control. TF-36 supplementation in T1 enhanced the antioxidant enzyme activity significantly (p
- Published
- 2017
47. Enhanced absorption and pharmacokinetics of fresh turmeric (Curcuma Longa L) derived curcuminoids in comparison with the standard curcumin from dried rhizomes
- Author
-
Dinesh Kumar, Balu Maliakel, Ramadassan Kuttan, Krishnakumar Im, and Eapen Ninan
- Subjects
Curcumin ,Fresh rhizomes ,Nutrition and Dietetics ,Bioavailability ,Curcuma longa L ,Traditional medicine ,biology ,Nutrition. Foods and food supply ,Chemistry ,Medicine (miscellaneous) ,Turmeric ,Absorption (skin) ,biology.organism_classification ,Rhizome ,chemistry.chemical_compound ,Pharmacokinetics ,Oral administration ,TX341-641 ,Curcuma ,Enhanced absorption ,Food Science - Abstract
Despite the various attempts to overcome the poor oral bioavailability of curcuminoids isolated from dried turmeric, no attempt has so far been reported on fresh turmeric derived curcuminoids. Herein, we report a novel preparation of curcuminoids from fresh turmeric rhizomes (FTC) as amorphous water soluble stable powder and its enhanced absorption and pharmacokinetics in comparison with 95% pure curcuminoids isolated from dried turmeric (DTC). While the oral administration of FTC at 250 mg/kg body weight was found to offer significant levels of plasma curcumin in Wistar rats for longer duration, an equivalent dose of curcuminoids as DTC failed to produce detectable plasma levels. Dose dependent human studies (100, 250 and 1000 mg doses of FTC) also showed significant (p
- Published
- 2015
48. Beyond the flavour: a de-flavoured polyphenol rich extract of clove buds (Syzygium aromaticum L) as a novel dietary antioxidant ingredient
- Author
-
D. Sureshkumar, Krishnakumar Im, G. Gopakumar, Renny Rm, Johannah Nm, and Balu Maliakel
- Subjects
Adult ,Male ,Taste ,Antioxidant ,Syzygium ,medicine.medical_treatment ,Phytochemicals ,Flavour ,Antioxidants ,Lipid peroxidation ,Ingredient ,chemistry.chemical_compound ,Botany ,medicine ,Animals ,Humans ,Food science ,Rats, Wistar ,Spices ,Pungency ,biology ,Plant Extracts ,Polyphenols ,General Medicine ,biology.organism_classification ,Rats ,chemistry ,Polyphenol ,Female ,Lipid Peroxidation ,Food Science - Abstract
Though kitchen spices constitute an important source of dietary antioxidants, their consumption at a physiologically relevant dose is very often hampered by their unpleasant flavour characteristics. The present paper describes a novel approach to derive stable de-flavoured spice extracts with minimised taste and odour profiles which are suitable for impregnation into a variety of food and beverage matrices at physiologically relevant doses. A popular kitchen spice, clove bud (Syzygium aromaticum L), having strong flavour and pungency characteristics was selected in the present study to derive a de-flavoured extract with a standardised polyphenolic profile (Clovinol) and was incorporated into various foods. The antioxidant efficacy of Clovinol on healthy human volunteers who check and answer official emails involving responsibility was investigated by analysing their endogenous antioxidant enzymes and the extent of lipid peroxidation upon consumption of Clovinol either as capsules or in a different food/beverage at 250 mg per serving per day for 30 days. It was observed that Clovinol can be conveniently incorporated in various food matrices without flavour issues and the consumption of such food/beverage items may support an effective detoxification process with an average elevation of 33 ± 3% in catalase, 66 ± 8% in SOD, 56 ± 5% in GPx and 167 ± 21% in GSH levels, and 81 ± 11% attenuation in membrane lipid peroxidation level.
- Published
- 2015
49. Toxicological evaluation of a saponin-rich standardized extract of fenugreek seeds (FenuSMART
- Author
-
D, Sureshkumar, Shamshad, Begum, N M, Johannah, Balu, Maliakel, and I M, Krishnakumar
- Subjects
Trigonella foenum graecum ,Phytoestrogen ,Subchronic toxicity ,Menopause ,Genotoxicity ,Article ,ComputingMethodologies_COMPUTERGRAPHICS ,Fenugreek extract - Abstract
Graphical abstract, Highlights • Safety evaluation of a standardized extract of fenugreek seeds (FenuSMART). • Acute and subchronic oral toxicity studies of FenuSMART on Wistar rats. • Mutagenicity study of FenuSMART., The present study investigated the safety of a saponin-rich standardized extract of fenugreek seeds (FenuSMART®; FHE), that has been clinically shown to be effective in ameliorating the postmenopausal discomforts and establishing hormonal balance. The safety was assessed by oral acute (2500 mg/kg b. wt. for 14 days) and subchronic (250, 500 and 1000 mg/kg b. wt. for 90 days) toxicity studies on Wistar rats and mutagenicity studies employing Salmonella typhimurium strains. Administration of FHE did not produce any toxicologically significant changes in clinical/behavioral observations, ophthalmic examinations, body weight, organ weight, feed consumption, urinalysis, hematology and clinical biochemistry parameters when compared to the untreated control group of animals. Highest dose recovery group (1000 mg/kg b. wt.) of animals also showed no mortality or adverse events; with hematological and biochemical parameters at par with those of controls. Terminal autopsy revealed no alterations in relative organ weight or any treatment-related histopathology changes. FHE also showed no mutagenicity upon Ames test employing TA-98, TA-100 and TA-102 Salmonella typhimurium strains with or without metabolic activation. Based on the results of the study, the no observed-adverse-effect level (NOAEL) of FHE was determined as 1000 mg/kg b. wt./day, the highest dose tested.
- Published
- 2017
50. Optimization of antioxidant efficacy of a deflavored and decolorized rosemary extract: effect of carnosol content on the oxidative stability of paprika colored beef patties
- Author
-
G. Gopakumar, P. S. Rajeev, Krishnakumar Im, Balu Maliakel, and Johannah Nm
- Subjects
Paprika oleoresin ,Antioxidant ,Autoxidation ,medicine.medical_treatment ,Carnosic acid ,04 agricultural and veterinary sciences ,Oxidative phosphorylation ,040401 food science ,Carnosol ,chemistry.chemical_compound ,0404 agricultural biotechnology ,Colored ,chemistry ,medicine ,Original Article ,Food science ,Butylated hydroxyanisole ,Food Science - Abstract
Considering the significance of natural antioxidants to preserve meat, the present study was undertaken to evaluate the efficacy of a deflavored and decolorised extract of rosemary (StabilRose™) for the production and preservation of naturally colored fresh meat. Oxidative rancidity of meat and color degradation of paprika oleoresin were exploited as model systems and compared with butylated hydroxyanisole (BHA). The results showed similar efficacy for 3% carnosic acid extract and BHA, with further enhancement in efficacy with respect to the carnosic acid content. A synergetic antioxidant effect of carnosol on carnosic acid content was also noticed to an extent of 1:1 (w/w) ratio, and further increase in carnosol content showed no improvement in the antioxidant efficacy. Finally, stabilized paprika and optimized rosemary extract containing carnosic acid and carnosol in 1:1 (w/w) ratio was successfully applied to produce naturally colored meat suitable for storage at 4 ± 1 °C.
- Published
- 2017
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.