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Background Recently, clinical research has suggested that red ginseng components play a role in liver protection and combating fatigue. However, fermented ginseng has not been analyzed for liver-protective or anti-fatigue effects. Objective This study evaluates the positive effects of fermented ginseng powder (GBCK25) on liver function. Methods Ninety participants with elevated alanine aminotransferase levels (35 ≤ ALT ≤1 05 IU/L) were randomized to one of three groups. The participants were treated with GBCK25 tablets at a dose of 500 mg/day (high dose), 125 mg/day (low dose), or placebo group daily for 12 weeks. The primary outcomes included changes in ALT and gamma-glutamyl transferase (GGT) levels. The secondary outcomes included changes in aspartate amino-transferase (AST), high-sensitivity C-reactive protein (hs-CRP), multidimensional fatigue scale, lipid profile, and antioxidant markers. Results In male subjects, after 12 weeks of low-dose GBCK25 (125 mg) supplementation, the GGT (P = 0.036) and hs-CRP (P = 0.021) levels decreased significantly more than those in the placebo group. High-dose GBCK25 (500 mg) supplementation significantly decreased the fatigue score compared with the placebo group. There were no clinically significant differences between the groups when studying any safety parameter. Conclusion Our results suggest that GBCK25 supplementation has beneficial effects on liver function. Trial registration This study was registered at Clinical Trials.gov (NCT03260543).

The aim of this study was to re-validate the changes in natural killer (NK) cell cytotoxicity and cytokines related to T cells after Sil-Q1 (SQ, silk peptide) supplementation in a larger pool of Korean adults with minimized daily dose of SQ and controlling seasonal influence compared to the previous study. A total of 130 subjects were randomly assigned (1:1) to consume either 7.5 g of SQ or placebo for 8 weeks. NK cell cytotoxicity and cytokines were measured at T0 (baseline) and T8 (follow-up). Comparing the NK cell cytotoxicity values at T0 and T8 within each group, the cytotoxicity at all effector cell (E) to target cell (T) ratios of 10:1, 5:1, 2.5:1, and 1.25:1 was significantly increased in the SQ group at T8. Additionally, significant differences in the changed value (Δ, subtract baseline values from follow-up values) comparison between the groups at E:T = 10:1, 5:1, and 2.5:1 were found. As a secondary endpoint, the interleukin (IL)-12 level in the SQ group was significantly increased for 8 weeks, and Δ IL-12 in the SQ group was greater than in the placebo group. In conclusion, the present study showed considerable practical implications of SQ supplementation. Thus, SQ is an effective and safe functional food supplement for enhancing immune function.

The goal of treatment for mild cognitive impairment (MCI) is to reduce the existing clinical symptoms, delay the progression of cognitive impairment and prevent the progression to Alzheimer’s disease (AD). At present, there is no effective drug therapy for AD treatment. However, early intake of dietary supplements may be effective in alleviating and delaying the MCI. This study aims to evaluate the effects of sesame oil cake extract (SOCE) supplementation on cognitive function in aged 60 years or older adults with memory impairment. A total of 70 subjects received either SOCE (n = 35) or placebo (n = 35) for 12 weeks based on random 1:1 assignment to these two groups. Cognitive function was evaluated by a computerized neurocognitive function test (CNT), and changes in the concentrations of plasma amyloid β (Aβ) proteins and urine 8-OHdG (8-hydroxy-2′-deoxyguanosine) were investigated before and after the experiment. Verbal learning test index items of the CNT improved markedly in the SOCE group compared to the placebo group (p &lt, 0.05). Furthermore, plasma amyloid-β (1–40) and amyloid-β (1–42) levels in the SOCE group decreased significantly compared to that in the placebo group (p &lt, 0.05). There was no statistically significant difference in urine 8-OHdG between the two groups (p &gt, 0.05). Collectively, intake of SOCE for 12 weeks appears to have a beneficial effect on the verbal memory abilities and plasma β-amyloid levels of older adults with memory impairment.

Steamed ginger ethanolic extract (SGE) is a product with a high 6-shogaol contents and is thought to be more potent than other ginger products. We conducted a 12-week, randomized, double-blind, placebo-controlled clinical trial to determine the effects of SGE on weight and body fat loss. Eighty healthy obese participants were recruited and randomly divided into the SGE and placebo groups. The outcome measures comprised indicators of efficacy (body weight, body mass index, body composition, and blood markers) and safety. Following the supplementation period, mean body weight, body mass index, and body fat level were significantly lower in the SGE group than in the placebo group. No clinically significant changes were observed for any safety parameter. These results suggest that SGE is a potent anti-obesity agent that does not cause significant side effects. Therefore, SGE supplementation combined with lifestyle modification could be effective in the management of body weight and fat mass. Electronic supplementary material The online version of this article (10.1007/s10068-019-00649-x) contains supplementary material, which is available to authorized users.

In this study, we evaluated the immunostimulatory effect of silk peptide in subjects with peripheral blood leukocyte levels of 4–8 × 103/μl by a randomized, double-blind, placebo-controlled clinical trial. The subjects were randomly assigned to one of two groups, the placebo control or silk peptide intervention group, for 8 weeks. As a result, evaluation of efficacy in 97 subjects showed no significant difference between the groups in immunostimulatory parameters. However, after separate analysis of 61 non-season influenza vaccine subjects, the natural killer cell activity (%) with an effector cell: target cell (E: T) ratio of 10:1 was increased significantly from 30.7 ± 2.28% at week 0 to 41.8 ± 2.71% at week 8 (p

Background The ethanol extract of Gynostemma pentaphyllum Makino leaves (EGP) has been reported recently to have anxiolytic effects on chronically stressed mice models. Purpose We aimed to investigate the efficacy and safety of EGP on anxiety level in healthy Korean subjects under chronic stressful conditions. Study design Double-blind, placebo-controlled trial. Methods This study was conducted with 72 healthy adults who had perceived chronic stress and anxiety with a score on the State-Trait Anxiety Inventory (STAI) from 40 to 60. Participants were randomly assigned to receive either EGP (200 mg, twice a day, N = 36) or placebo (N = 36). All participants were exposed to repetitive loads of stress by performing the serial subtraction task for 5 min every second day during the 8-week intervention. Primary outcome of Trait-STAI and secondary outcomes of State-STAI, total score of STAI, Hamilton Anxiety Inventory (HAM-A), Beck Anxiety Inventory (BAI), blood norepinephrine and adrenocorticotropic hormone (ACTH), salivary cortisol and alpha-amylase, cardiovascular autonomic nervous system (ANS) functional test, and heart rate variability (HRV) test were measured before and after intervention. Results After the 8-week intervention, the EGP significantly lowered the score of the Trait Anxiety Scale of the STAI (T-STAI) by 16.8% compared to the placebo (p = 0.041). The total score on the STAI decreased by 17.8% in the EGP group and tended to improve compared with that of the placebo group (p = 0.067). There were no significant differences in the changes in score of S-STAI, HAM-A, BAI, and other parameters from baseline between the two groups. There was no causal relationship between the ingestion of EGP and adverse drug reactions. Conclusion We found that supplementation with EGP reduced “anxiety proneness” in subjects under chronic psychological stress, as shown by a decrease in the score of T-STAI and the tendency for decrease in the total score of STAI. This result suggests that EGP supplementation can be used as a regimen to safely reduce stress and anxiety; however, more studies are needed to establish the long-term safety and effectiveness.

Objective: The purpose of this study was to determine if Porphyra tenera extract (PTE) has immune-enhancing effects and is safe in healthy adults. Methods: Subjects who met the inclusion criteria (3 &times, 103 &le, peripheral blood leukocyte level &ge, 8 &times, 103 cells/&micro, L) were recruited for this study. Enrolled subjects (n = 120) were randomly assigned to either the PTE group (n = 60) and were given 2.5 g/day of PTE (as PTE) in capsule form or the placebo group (n = 60) and were given crystal cellulose capsules with the identical appearance, weight, and flavor as the PTE capsules for 8 weeks. Outcomes were assessed based on measuring natural killer (NK) cell activity, cytokines level, and upper respiratory infection (URI), and safety parameters were assessed at baseline and 8 weeks. Results: Compared with baseline, NK cell activity (%) increased for all effector cell-to-target cell ratios in the PTE group after 8 weeks, however, changes were not observed in the placebo group (p &lt, 0.10). Subgroup analysis of 101 subjects without URI showed that NK cell activity in the PTE group tended to increase for all effector cell/target cell (E:T) ratios (E:T = 12.5:1 p = 0.068, E:T = 25:1 p = 0.036, E:T = 50:1 p = 0.081) compared with the placebo group. A significant difference between the two groups was observed for the E:T = 25:1 ratio, which increased from 20.3 &plusmn, 12.0% at baseline to 23.2 &plusmn, 12.4% after 8 weeks in the PTE group (p = 0.036). A significant difference was not observed in cytokine between the two groups. Conclusion: PTE supplementation appears to enhance immune function by improving NK cell activity without adverse effects in healthy adults.

Objective: The purpose of this study was to determine if Porphyra tenera extract (PTE) has immune-enhancing effects and is safe in healthy adults. Methods: Subjects (3x103 ≤ peripheral blood leukocyte levels < 8x103 cells/μl) who met the inclusion criteria were recruited for this study. Enrolled subjects (n=120) were randomly assigned to either the PTE group (n=60) who were given 2.5 g/day of PTE (as Porphyra tenera extract) in capsule form or the placebo group (n=60) who were given crystal cellulose capsules with the identical appearance, weight, and flavor as the PTE capsules for 8 weeks. Outcomes were assessed by measuring natural killer cell (NK-cell) activity, cytokines, and upper respiratory infection (URI), and safety parameters were assessed at baseline and 8 weeks. Results: Compared to baseline, NK cell activity (%) increased for all effector cell to target cell ratios in the PTE group after 8 weeks, but there were no changes in the placebo group (p

Objective: The purpose of this study was to determine if Porphyra tenera extract (PTE) has immune-enhancing effects and is safe in healthy adults. Methods: Subjects who met the inclusion criteria (3 × 103 ≤ peripheral blood leukocyte level ≥ 8 × 103 cells/µL) were recruited for this study. Enrolled subjects (n = 120) were randomly assigned to either the PTE group (n = 60) and were given 2.5 g/day of PTE (as PTE) in capsule form or the placebo group (n = 60) and were given crystal cellulose capsules with the identical appearance, weight, and flavor as the PTE capsules for 8 weeks. Outcomes were assessed based on measuring natural killer (NK) cell activity, cytokines level, and upper respiratory infection (URI), and safety parameters were assessed at baseline and 8 weeks. Results: Compared with baseline, NK cell activity (%) increased for all effector cell-to-target cell ratios in the PTE group after 8 weeks; however, changes were not observed in the placebo group (p < 0.10). Subgroup analysis of 101 subjects without URI showed that NK cell activity in the PTE group tended to increase for all effector cell/target cell (E:T) ratios (E:T = 12.5:1 p = 0.068; E:T = 25:1 p = 0.036; E:T = 50:1 p = 0.081) compared with the placebo group. A significant difference between the two groups was observed for the E:T = 25:1 ratio, which increased from 20.3 ± 12.0% at baseline to 23.2 ± 12.4% after 8 weeks in the PTE group (p = 0.036). A significant difference was not observed in cytokine between the two groups. Conclusion: PTE supplementation appears to enhance immune function by improving NK cell activity without adverse effects in healthy adults.

Silk peptide, the hydrolysate of silk protein derived from cocoons, has been employed as a biomedical material and is believed to be safe for human use. Silk peptide display various bioactivities, including anti-inflammatory, immune-regulatory, anti-tumor, anti-viral, and anti-bacterial. Although earlier investigations demonstrated that silk peptide stimulates macrophages and the production of pro-inflammatory cytokines, its effect on natural killer (NK) cell function has not yet been explored. In this study, we initially confirmed that silk peptide enhances NK cell activity in vitro and ex vivo. To assess the modulatory activity of silk peptide on NK cells, mice were fed various amounts of a silk peptide-supplemented diet for 2 months and the effects on immune stimulation, including NK cell activation, were evaluated. Oral administration of silk peptide significantly enhanced the proliferation of mitogen- or IL-2-stimulated splenocytes. In addition, oral silk peptide treatment enhanced the frequency and degree of maturation of NK cells in splenocytes. The same treatment also significantly enhanced the target cell cytolytic activity of NK cells, which was determined by cell surface CD107a expression and intracellular interferon-γ expression. Finally, oral administration of silk peptide stimulated T helper 1-type cytokine expression from splenic lymphocytes. Collectively, our results suggest that silk peptide potentiates NK cell activity in vivo and could be used as a compound for immune-modulating anti-tumor treatment.

In our previous study, Hizikia fusiformis extract (HFE) has gastroprotective effects in animal model for gastric ulcer. The purpose of this study was to investigate whether HFE had similar gastro-protective effects in human subjects. A randomized, double-blind, placebo-controlled trial was conducted. To fulfill this purpose, a group of subjects with erosive gastritis were orally supplemented with the HFE or placebo for 4 weeks and efficacy and safety were measured. Primary outcome (number of erosions, endoscopic score and estimated cure rates of erosions) and the secondary outcomes (estimated improvement rates of erosions, subjects’ symptom questionnaires and blood profiles) before and after the 4-week intervention period were compared. The HFE supplementation showed a significant reduction in number of erosions compared with placebo group. In subjects whose endoscopic score were 4 points (erosions more than 6) at baseline, HFE supplementation resulted in a significant decrease of number of erosions compared with placebo group. High sensitive-C reactive protein (hs-CRP) levels showed a tendency to decrease in HFE-supplemented group. Finally, blood parameters and clinical findings for organ toxicity remained within the normal range. These results suggest that HFE may have therapeutic potential in subjects with erosive gastritis.

Background: Studies in animals have demonstrated the antiallergenic properties of Chongkukjang (CKJ), a traditional Korean food made by fermentation of soybean with Bacillus subtilis. CKJ might therefore be used as an ingredient in a functional food designed to suppress allergies. The purpose of this study was to investigate the effect of CKJ on histamine-induced skin wheal response in healthy participants. Methods: A randomized, double-blind, placebo-controlled trial was conducted. Sixty participants (48 women and 12 men) were randomly assigned to one of two groups: One group received 35 g CKJ daily for 12 weeks, and the other received a placebo at the same dosing frequency. A skin prick test with histamine (10 mg/mL) was conducted on the ventral forearm 10 cm from the elbow, and assessed 15 minutes later. Outcomes included measurement of efficacy [skin wheal response, immunoglobulin E (IgE), histamine, interferon-gamma, interleukin-4, eosinophil, and eosinophil cationic protein (ECP)], and safety (adverse events, laboratory test results, electrocardiogram, anthropometric values, and vital signs). Results: Fifty-five participants (28 in the CKJ group and 27 in the placebo group) completed the study. After 12 weeks of supplementation, participants in the CKJ group showed a significant reduction in histamine-induced skin wheal areas compared with placebo group (p

Constipation affects up to 20% of the world's population. The aim of this study was to investigate whether supplementation with Ficus carica paste could be used to treat constipation in Korean subjects with functional constipation.We conducted a randomized, double-blind, placebo-controlled trial. Subjects with functional constipation were orally supplemented with either F. carica paste (n=40) or placebo (n=40) for 8 weeks. We measured the efficacy and safety of F. carica paste. Primary outcomes (colon transit time) and secondary outcomes (questionnaire related to defecation) were compared before and after the 8-week intervention period.F. carica paste supplementation was associated with a significant reduction in colon transit time and a significant improvement in stool type and abdominal discomfort compared with the placebo. Blood parameters and clinical findings for organ toxicity remained within normal ranges.These results suggest that F. carica paste may have beneficial effects in subjects suffering from constipation.背景和目的：便秘影响到世界人口的20%。这项研究目的是探讨无花果酱是 否可以用于韩国功能性便秘患者的治疗。方法与研究设计：我们进行了一项 随机、双盲与安慰剂对照试验。功能性便秘患者摄入无花果酱（n=40）或安 慰剂（n=40）8 周。测定无花果酱的疗效和安全性并且比较8 周前后干预的主 要疗效（结肠转运时间）和次要疗效（涉及到排便的调查问卷）。结果：与 安慰剂组比较，无花果酱能显著减少结肠转运时间，改善粪便类型和腹部不 适。血液和器官毒性的临床参数均保持在正常范围以内。结论：这些结果表 明无花果酱可能对便秘患者产生有益的影响。.

Aims Multiple pathogenic pathways are involved in diabetic neuropathy and diverse treatments have been tried without success. The aim of this study was to assess the effect of α-lipoic acid on skin blood flow in patients with diabetic neuropathy. Methods We measured skin blood flow in 13 control subjects and 19 patients with diabetic neuropathy using the laser Doppler blood flow technique. Skin blood flow and the extent of skin blood flow changes were compared before and after diabetic patients received 600 mg/day α-lipoic acid intravenously for 14 days. Results Although no significant differences in absolute values of skin blood flow or in the extent of changes were noted, symptoms were reduced after α-lipoic acid treatment. Conclusions This study suggests that α-lipoic acid, a potent antioxidant, improves symptoms of diabetic neuropathy. Larger studies are needed to determine whether improvements in skin blood flow also occur in patients with diabetic neuropathy.

Aims The objectives of this study were to evaluate the prevalence of and risk factors for extracranial internal carotid artery stenosis in Type 2 diabetic patients. Methods This study included 406 patients aged 40–79 years with Type 2 diabetes (male 55.4%, female 44.6%). Both carotid arteries of each patient were examined by carotid duplex scanning. The duplex ultrasound criteria based on the North American Symptomatic Carotid Endarterectomy Trial (NASCET) measurement method were used for the identification of carotid stenosis. Results Extracranial internal carotid artery stenosis ≥ 40% by velocity criteria was detected in 5.2% of the patients. The prevalence of carotid stenosis increased with advancing age: 1.0% at 40–49 years of age, 5.0% at 50–59 years, 7.3% at 60–69 years and 9.5% at 70–79 years. The degree of stenosis was > 70% in 42.9% of patients with stenosis, Bilateral stenosis was detected in 14% of patients. Of the patients with ≥ 40% carotid stenosis, 33% had a decreased ankle-brachial index, 38% had a previous history of stroke, and only one patient (5%) had a documented history of coronary artery disease. Multivariate analysis, including variables determined to be significantly different by univariate analysis between patients with or without ≥ 40% stenosis, indicated that age, systolic blood pressure and high-density lipoprotein (HDL)-cholesterol (inverse correlation) were independent risk factors associated with carotid stenosis. Conclusions Carotid duplex scanning is a useful strategy in identifying carotid stenosis in older Type 2 diabetic patients with high systolic blood pressure, or low levels of HDL cholesterol. The early identification and subsequent appropriate management of carotid stenosis, particularly in this group of patients, may facilitate efforts to reduce the incidence of macrovascular complications.

Background Liver transplantation (LT) may induce the occurrence of diabetes mellitus. It can be speculated, however, that the LT may have a beneficial effect on glucose metabolism. We therefore conducted a study to examine the changing trends in blood glucose levels before and after LT in patients with prediabetes or type 2 diabetes. Methods In this observational study, we enrolled 47 patients (38 prediabetes and 9 diabetes) who underwent LT. We compared the blood glucose levels between the pre-transplantation (24 months) and the post-transplantation (36 months) periods and analyzed the diverse factors affecting glucose levels. Results The glucose regulation worsened and insulin dose increased in patients with diabetes, which was notably seen during the steroid maintenance period. Following steroid withdrawal, however, there was a decrease in the insulin dose in 55.6% of the patients, and 33.3% of the patients converted from insulin to oral agents. Of the patients with prediabetes, 55.3% developed new-onset diabetes after transplantation (NODAT). However, 18.4% achieved a recovery of glucose levels to normal range. Of the 21 NODAT patients, 52.4% achieved a recovery of glucose level to the prediabetes range after steroid withdrawal. There was a significant correlation between the old age and the persistence of NODAT ( P Conclusions LT may have a diverse effect on glycemia, which may lead to changes in glucose control methods. Therefore, glucose metabolism after LT may need to be differentiated by the underlying glucose disturbance status and the time after LT with or without steroid maintenance period.

The incidence of diabetes and its complication have rapidly increased. Decreased quality of life and increased mortality are the major problems of people with diabetes. These problems are mainly caused by chronic complications. The incidence of diabetic neuropathy, which is one of these chronic complications, approaches 50% in most diabetic patients. The intensive metabolic management alone cannot completely prevent the development and progression of diabetic complications. Therefore, blocking and management of pathogenic mechanism of complication are required. Pathogenesis of diabetic neuropathy has multifactorial causes. Diabetic neuropathy is thought to occur both from direct hyperglycemia-induced damage to the nerve parenchyma and from neuronal ischemia brought about indirectly by hyperglycemia-induced decreases in neurovascular flow. The effects of hyperglycemia get converted to neuronal dysfunction via at least three secondary biochemical pathways: the polyol pathway, non-enzymatic glycation of proteins, oxidative stress and protein kinase C, and the interactions between them. Because of these interactions, interference with one of these biochemical pathways could either worsen or attenuate the effects of the others. So, the use of therapeutic intervention of these pathways is inevitable and valid to prevent the progression of diabetic neuropathy. As yet, a satisfactory and fundamental, preventive, and therapeutic method is not available with us to prevent progression. So, we will introduce the earlier diagnostic methods of diabetic neuropathy and will discuss the advantages and limitations of each method.

To elucidate the molecular mechanism in relation to vascular supply and osteoporosis, we investigated the effect of hypoxia on Runx2 expression in MG63 cells. Also investigated was expression of type I collagen and osteocalcin, which are regulated by Runx2, alkaline phosphatase (ALPase) to see if they are affected by hypoxia. Quiescent cultures of MG63 cells were exposed to hypoxia (2% O(2)) and normoxia (18% O(2)) for 24, 48, 72 and 96 h. In cells exposed to hypoxia, reverse transcription-polymerase chain reaction (RT-PCR) analysis showed that mRNA expression of Runx2, type I collagen, osteocalcin, and ALPase were decreased in a time dependent manner to 96 h. Activity of ALPase was also reduced in the same manner. Western blotting showed a marked decrease in Runx2 protein at 96 h in cells under hypoxia compared to normoxia. These data indicate that Runx2 expression in osteoblasts is reduced by hypoxia, and may be a mechanism of osteoporosis by decreased vascular supply.

Diabetic muscle infarction is a rare complication of diabetes and has characteristic clinical features including acute onset of pain with painful swelling, most commonly in the thigh or calf muscle, which gradually improves to complete resolution. Recently we experienced a case of diabetic muscular infarction presenting as knee joint pain due to involvement of the proximal portion of the leg muscle, which site has not been reported previously. This case shows that diabetic muscle infarction may involve sites other than the thigh and calf areas and should be considered in the differential diagnosis of knee arthralgia.

Vascular involvement in Behcet's disease is divided into venous and arterial thrombosis and arterial aneurysmal formation. Subclavian arterial aneurysm rarely occurs in Behcet's disease; however, when it does occur, it causes serious aneurysmal rupture and local complications such as nerve compression and arterial ischemia. We describe the case of a 39-year-old male who presented with neurologic symptoms and signs of brachial plexopathy and mediastinal mass caused by Behcet's subclavian arterial aneurysm. This case shows that the occurrence of brachial plexopathy should be considered a manifestation of Behcet's disease, and that Behcet's aneurysm should be considered in the differential diagnosis of upper mediastinal mass.