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1. Changing the tone of clinical study design in the cannabis industry

Author

Antony Joseph M, McDonald Alison C., Noorbakhsh Farshid, Guthrie Najla, and Evans Mal

Subjects
cannabinoid, brain activity, circadian rhythms, clinical trials, Neurosciences. Biological psychiatry. Neuropsychiatry, RC321-571
Abstract

Cannabis (also known as marijuana) is the most frequently used psychoactive substance globally. Cannabis exerts therapeutic functions for many indications and has vast potential as a health and wellness product. Advances in our understanding of the composition and pharmacological properties of cannabis have revealed interactions between cannabis, an individuals’ circadian rhythms and their endocannabinoid signaling. Exogenously administered cannabinoids can bidirectionally entrain central and peripheral clocks that comprise circadian rhythms, and malfunctions in the endocannabinoid system are reported to impact neurological processes. Therefore, it is necessary to account for the circadian rhythm when designing clinical trials examining the pharmacological properties of cannabis-based products for health and wellness to limit its potential confounding impact on results. Consideration of the entrainment capabilities of the endocannabinoid system is warranted when designing clinical trials.

Published
2020
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2. The essentials of a global index for cognitive function

Author

Antony Joseph Mathew, Weaver Ian, Rueffer Matthew, Guthrie Najla, and Evans Malkanthi

Subjects
cognition, dietary supplements, neuropsychological tests, global index, Neurosciences. Biological psychiatry. Neuropsychiatry, RC321-571
Abstract

Cognition is comprised of the faculties: perception, creativity, intuition, and ratiocination. Optimal levels of cognition are needed for independent functioning and balanced living. With an aging population that continues to grow, dietary supplements that tilt the balance towards maintenance of cognition are being marketed for vulnerable populations facing these challenges. Randomized clinical trials provide the causal inference necessary to define the efficacy of emerging nutraceuticals. Cognition testing, in particular, requires a battery of tests that encompass all brain regions involved in cognition so as to provide endpoints necessary for product validation. The lack of well controlled studies for comparison analyses, limited sample sizes, ambiguous dosages, and poor cognitive measures result in data that cannot be compared across studies to determine the efficacy of supplements claiming to enhance cognition. Clinical trials for the nutraceutical industry should consider the multifaceted nature of supplements, where clinical endpoints must be comprehensive while remaining feasible. Combining endpoints of cognition with physiological biomarkers of immunity and metabolism to arrive at a global index for cognitive health may be necessary for claim substantiation in order to fully justify and scientifically validate improvements in cognitive health. The issues and needs of a global index will be discussed here.

Published
2017
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7. Contributors

Author

Aggarwal, Manoj, primary, Akingbasote, James, additional, Anadón, Arturo, additional, Anger, Gregory J., additional, Archibong, Anthony E., additional, Ares, Irma, additional, Aschner, Michael, additional, Avila, Daiana S., additional, Bailey, Denise C., additional, Barlow, Norman J., additional, Beedanagari, Sudheer, additional, Beltyukov, P.P., additional, Bischoff, Karyn, additional, Boeck, Carina Rodrigues, additional, Bracken, William M., additional, Brehm, Emily, additional, Breyer, Richard M., additional, Bright-Ponte, Susan, additional, Brockett, Mirjana Milosevic, additional, Campagnolo, Luisa, additional, Carney, Edward W., additional, Charrette, Andrew, additional, Chebekoue, Sandrine Fleur, additional, Chiang, Catheryne, additional, Chou, Wei-Chun, additional, Cleal, Jane K., additional, Cole, Toby B., additional, Cook, Daniel, additional, Coppock, Robert W., additional, Costa, Lucio G., additional, Curras-Collazo, Margarita, additional, Dai, Wanying, additional, Dao, Khoi, additional, Da Silva, Rosane Souza, additional, Davis, T. Zane, additional, Dominguez, Francisco, additional, Doss, Robin B., additional, Dziwenka, Margitta M., additional, Enright, Brian, additional, Estevan, Carmen, additional, Evans, Timothy J., additional, Fan, Anna M., additional, Farina, Marcelo, additional, Fenton, Suzanne E., additional, Filazi, Ayhan, additional, Fitsanakis, Vanessa A., additional, FitzGerald, Rex, additional, Flaskos, John, additional, Flaws, Jodi A., additional, Flora, S.J.S., additional, Ganjam, Vekataseshu K., additional, Gardner, Dale R., additional, Garg, Ramesh C., additional, Garrick, Jacqueline M., additional, Garry, Vincent F., additional, Gelineau-van Waes, Janee, additional, Godfrey, Keith M., additional, Golubentseva, Yu V., additional, González-Martín, Roberto, additional, Green, Benedict T., additional, Guerri, Consuelo, additional, Gulati, Kavita, additional, Gupta, P.K., additional, Gupta, Ramesh C., additional, Gupta, Rekha K., additional, Guthrie, Najla, additional, Hall, Jeffery O., additional, Hargreaves, Alan J., additional, Harris, Kenneth J., additional, Hill, Bridgett N., additional, Hilmas, Corey J., additional, Hoberman, Alan M., additional, Hougaard, Karin S., additional, Ince, Sinan, additional, Iyer, Poorni R., additional, Jacobsen, Nicklas R., additional, Kalpana, Starling, additional, Kandimalla, Ramesh, additional, Kanthasamy, Arthi, additional, Kanthasamy, Anumantha, additional, Khlebnikova, N.S., additional, Klüver, Nils, additional, Kodavanti, Prasada Rao S., additional, Krishnan, Kannan, additional, Kulkarni, Shaila, additional, Kuzukiran, Ozgur, additional, Lall, Rajiv, additional, Legradi, Jessica, additional, Lewis, Rohan M., additional, Lewis, Elise M., additional, Li, Xin, additional, Lin, Pinpin, additional, Loganathan, Bommanna G., additional, Machado, Ivo F., additional, Mahadevan, Brinda, additional, Makris, Susan L., additional, Malik, Jitendra K., additional, Marreilha dos Santos, Ana Paula, additional, Marsillach, Judit, additional, Martínez-Larrañaga, María Rosa, additional, Martínez, María Aránzazu, additional, Matouskova, Klara, additional, McClellan, Roger O., additional, Milatovic, Dejan, additional, Mohammed, Ali Mustafa, additional, Montine, Thomas J., additional, Møller, Peter, additional, Multani, Pushpinder Kaur, additional, Ni, Mingwei, additional, Nikolaidis, Efstathios, additional, Novilla, Meliton N., additional, Padilla, Stephanie, additional, Palmeira, Carlos M., additional, Pamies, David, additional, Panner Selvam, Manesh Kumar, additional, Pascual, María, additional, Patwa, Jayant, additional, Phillips, Ashley, additional, Piquette-Miller, Micheline, additional, Popov, V.B., additional, Pratt, M. Margaret, additional, Protasova, G.A., additional, Rai, Nishant, additional, Ramalho-Santos, João, additional, Ramesh, Aramandla, additional, Ray, Kausik, additional, Ray, Arunabha, additional, Ren, Aiguo, additional, Renaud, Stephen J., additional, Roberts, Drucilla J., additional, Rongzhu, Lu, additional, Sachana, Magdalini, additional, Sahlman, Heidi, additional, Saini, Nitin, additional, Saini, Vandna, additional, Shabasheva, L.V., additional, Sharma, Abha, additional, Sikka, Suresh C., additional, Silva, Marilyn Helen, additional, Simsek, Ilker, additional, Singh Kalra, Rajkumar, additional, Sinha, Anita, additional, Sogorb, Miguel A., additional, Soldin, Offie P., additional, Song, Chunjuan, additional, Srivastava, Ajay, additional, Stice, Szabina A., additional, Stoker, Tammy E., additional, Stonecipher, Clinton A., additional, Szlapinski, Sandra, additional, Tanabe, Shihori, additional, Tatiparthi, Arun, additional, Teixeira da Rocha, João Batista, additional, Thokchom, Suresh Kumar, additional, Tornesi, Belen, additional, Torous, Vanda, additional, Truran, Peter, additional, Valdez, Matthew C., additional, Vandenberg, Laura N., additional, Vargesson, Neil, additional, Vilanova, Eugenio, additional, Vähäkangas, Kirsi H., additional, Vulimiri, Suryanarayana V., additional, Warner, Genoa R., additional, Welch, Kevin D., additional, Williams, Daniel C., additional, Woldemeskel, Moges, additional, Yang, Jae-Ho, additional, Yin, Zhaobao, additional, Ying, Xiaoyou, additional, Yurdakok-Dikmen, Begum, additional, Zaja-Milatovic, Snjezana, additional, and Zhou, Changqing, additional

Published
2022
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13. List of contributors

Author

Ahmad, Abul H., primary, Akingbasote, James, additional, Anadón, Arturo, additional, Anand, Rashmi, additional, Anantharam, Vellareddy, additional, András, Csaba, additional, Ares, Irma, additional, Avdonin, Pavel V., additional, Ay, Muhammet, additional, Banerjee, Aryamitra, additional, Barnett, Reid E., additional, Belinskaia, Daria A., additional, Bertero, Alessia, additional, Bharti, Vijay K., additional, Bian, Wan-Ping, additional, Bischoff, Karyn L., additional, Caloni, Francesca, additional, Castela, Ana Catarina, additional, Chand, Naresh, additional, Chanderbhan, Ronald F., additional, Charli, Adhithiya, additional, Charrette, Andrew, additional, Chen, Si, additional, Chen, Tao, additional, Choudhuri, Supratim, additional, Choudhury, Soumen, additional, Coccini, Teresa, additional, Cope, Rhian B., additional, Coppock, Robert W., additional, Costa, Lucio G., additional, Damodaran, Tirupapuliyur, additional, Darvesh, Altaf S., additional, Dhruw, Leena, additional, Dormán, György, additional, Doss, Robin B., additional, DuBourdieu, Dan, additional, Dziwenka, Margitta, additional, Eades, Joshua, additional, Esch, Harald L., additional, Filazi, Ayhan, additional, Fitsanakis, Vanessa A., additional, Flachner, Beáta, additional, Fossati, Paola, additional, Gambaryan, Stepan P., additional, Garg, Ramesh C., additional, Garg, Satish K., additional, Gil, Fernando, additional, Goncharov, Nikolay V., additional, Gulati, Kavita, additional, Guo, Lei, additional, Guo, Xiaoqing, additional, Gupta, Bhanushree, additional, Gupta, Ramesh C., additional, Guthrie, Najla, additional, Gwaltney-Brant, Sharon M., additional, Hajdú, István, additional, Hartsel, Joshua A., additional, Hazzah, Trina, additional, Hernández, Antonio F., additional, Hickory, Brian, additional, Hilmas, Corey J., additional, Hoeng, Julia, additional, Jain, Amul, additional, Jenkins, Richard O., additional, Jin, Huajun, additional, Joshi, Jagdish Chandra, additional, Kalinovsky, Tatiana, additional, Kalpana, Starling, additional, Kalidindi, Sanyasi R., additional, Kanthasamy, Anumantha G., additional, Kanthasamy, Arthi, additional, Kaore, Navinchandra M., additional, Kaore, Shilpa N., additional, Kapoor, Vijay Kumar, additional, Kaur, Gurjot, additional, Kolanos, Renata, additional, Korf, Ekaterina A., additional, Krishna, Gopala, additional, Krishna, Mayur, additional, Kuča, Kamil, additional, Kudryavtsev, Igor V., additional, Kumar, Amit, additional, Kumar, Dinesh, additional, Kumar, Prafull, additional, Lall, Rajiv, additional, La Mesa, Camillo, additional, Latino, Diogo A.R.S., additional, Lehmann, Leane, additional, Li, Xilin, additional, Machado, Ivo F., additional, Makriyannis, Alexandros, additional, Malik, Jitendra K., additional, Martín-Domingo, M. Concepción, additional, Martínez, María-Aránzazu, additional, Martínez-Larrañaga, María-Rosa, additional, Mei, Nan, additional, Messinis, Dimitris E., additional, Mindukshev, Igor V., additional, Negi, Poonam, additional, Niedzwiecki, Aleksandra, additional, Ning, Baitang, additional, Novozhilov, Artem V., additional, Palmeira, Carlos Marques, additional, Papas, Andreas M., additional, Pei, De-Sheng, additional, Peitsch, Manuel C., additional, Peterson, Jeffrey D., additional, Pistollato, Francesca, additional, Pitt, Jason, additional, Pitt, Yiuka, additional, Pospisil, Pavel, additional, Poussin, Carine, additional, Pradhan, Aanchal, additional, Prakash, Atul, additional, Prasad, Sahdeo, additional, Rahal, Anu, additional, Rai, Nishant, additional, Raina, Rajinder, additional, Rath, Matthias, additional, Ray, Arunabha, additional, Rehman, Sana, additional, Richter, Gary, additional, Risuleo, Gianfranco, additional, Roberts, Ashley, additional, Rolo, Anabela Pinto, additional, Roomi, M. Waheed, additional, Sachana, Magdalini, additional, Satoh, Tetsuo, additional, Serebriakova, Maria K., additional, Sharma, Rahul, additional, Shukla, Amit, additional, Sinha, Anita, additional, Sinha, Priynak, additional, Spicer, Leon J, additional, Srivastava, Ajay, additional, Stice, Szabina A., additional, Sudnitsyna, Julia S., additional, Taku, Ila, additional, Talukder, Jamil, additional, Teodoro, João Soeiro, additional, Thokchom, Suresh Kumar, additional, Trulioff, Andrey S., additional, Ukolov, Anton I., additional, Umegaki, Keizo, additional, Verma, Pankaj, additional, Verma, Pawan K., additional, Wan, Dan, additional, Wilson-Frank, Christina, additional, Woldemeskel, Moges, additional, Wu, Qinghua, additional, Yang, Mildred S., additional, Yurdakok-Dikmen, Begum, additional, Zaja-Milatovic, Snjezana, additional, and Zoltani, Csaba K., additional

Published
2021
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14. Cannabidiol safety

Author

Charrette, Andrew, primary, Akingbasote, James, additional, Guthrie, Najla, additional, and Hilmas, Corey J., additional

Published
2021
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17. Role of Acacia catechu and Scutellaria baicalensis in Enhancing Immune Function Following Influenza Vaccination of Healthy Adults: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial.

Author

Lewis, Erin D., Crowley, David C., Guthrie, Najla, and Evans, Malkanthi

Abstract

The study aimed to examine the role of an Acacia catechu and Scutellaria baicalensis formulation, UP446, on supporting immune function in response to influenza vaccination. A randomized, triple-blind, placebo-controlled, parallel study consisted of a 56-day intervention period with a 28-day pre-vaccination period, an influenza vaccination on Day 28 and 28-day post-vaccination period. Fifty healthy adults 40–80 years of age who had not received their flu vaccine were randomized to either UP446 or Placebo. At baseline, Days 28 and 56, immune and oxidative stress markers were measured in blood and a quality of life questionnaire was administered. Participants completed the Wisconsin Upper Respiratory Symptom Survey (WURSS)-24 daily. In the post-vaccination period, total IgA and IgG levels increased in participants supplemented with UP446 vs. those on Placebo (p ≤ 0.026). As well, influenza B-specific IgG increased 19.4% from Day 28 to 56 and 11.6% from baseline at Day 56 (p ≤ 0.0075). Serum glutathione peroxidase (GSH-Px) was increased in the pre-vaccination period and from baseline at Day 56 with UP446 supplementation (p ≤ 0.0270). These results suggest a 56-day supplementation with UP446 was beneficial in mounting a robust humoral response following vaccination. Increasing GSH-Px in the pre-vaccination period may help improve antioxidant functions and potentially mitigate the oxidative stress induced following vaccination. [ABSTRACT FROM AUTHOR]

Published
2023
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19. A Randomized, Placebo-controlled, Triple-blind Study to Determine the Effect of Farlong Ginseng Plus® NotoGinseng Extract on Cholesterol and Blood Pressure

Author

Zeng Andy, Struve Jing, Guthrie Najla, D. Lewis Erin, C. Crowley David, and Evans Malkanthi

Subjects
Cultural Studies, Linguistics and Language, History, Triple-Blind Study, business.industry, Cholesterol, Pharmacology, Placebo, Language and Linguistics, Ginseng, chemistry.chemical_compound, Blood pressure, chemistry, Anthropology, Medicine, business
Abstract

Objective: This randomized, placebo-controlled, triple-blind study examined the efficacy of 12 weeks of Farlong NotoGinsengTM (FNG) supplementation on LDL-C and blood pressure (BP) in otherwise healthy participants (n=95) with normal to mild hypertension and hypercholesterolemia. Methods: Lipid profile, BP, and endothelial vasodilation parameters were assessed at baseline and weeks 4, 8 and 12. Safety was assessed at screening and at end of the study. The Therapeutic Lifestyle Change (TLC) diet was followed during a 4-week run-in and throughout. Results: Participants on FNG had a 4.33% reduction in LDL-C at week 8 (p=0.045) and a 1.80% improvement in HDL-C at week 12. Those on placebo had a non-significant 1.37% HDL-C reduction at both weeks 8 and 12. The FNG group showed a 0.94% reduction in systolic (SBP) and a 0.16% reduction in diastolic BP (DBP) at week 12. The placebo group had 0.5% and 1.24% increases in SBP and DBP, respectively. A total of 17.5% of participants supplemented with FNG had improvements in all three CVD risk factors (LDL-C, HDL-C, and SBP) compared to 5.0% of those on placebo (p=0.040). A greater proportion of participants with borderline high baseline LDL-C had reductions in their CVD risk factors (p=0.037) with FNG. However, participants in the placebo group with similar LDL-C characteristics did not have improvements in either their BP or lipid profile. Conclusion: FNG was well-tolerated and may have a positive influence on reducing CVD risk by improving BP and lipid profile. Left unaddressed, those with CVD risk factors may progress to a more hypertensive and hypercholesterolemic state.

Published
2021

23. Role of Acacia catechuand Scutellaria baicalensisin Enhancing Immune Function Following Influenza Vaccination of Healthy Adults: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial

Author

Lewis, Erin D., Crowley, David C., Guthrie, Najla, and Evans, Malkanthi

Abstract

AbstractObjectiveThe study aimed to examine the role of an Acacia catechuand Scutellaria baicalensisformulation, UP446, on supporting immune function in response to influenza vaccination.MethodsA randomized, triple-blind, placebo-controlled, parallel study consisted of a 56-day intervention period with a 28-day pre-vaccination period, an influenza vaccination on Day 28 and 28-day post-vaccination period. Fifty healthy adults 40–80 years of age who had not received their flu vaccine were randomized to either UP446 or Placebo. At baseline, Days 28 and 56, immune and oxidative stress markers were measured in blood and a quality of life questionnaire was administered. Participants completed the Wisconsin Upper Respiratory Symptom Survey (WURSS)-24 daily.ResultsIn the post-vaccination period, total IgA and IgG levels increased in participants supplemented with UP446 vs. those on Placebo (p ≤ 0.026). As well, influenza B-specific IgG increased 19.4% from Day 28 to 56 and 11.6% from baseline at Day 56 (p ≤ 0.0075). Serum glutathione peroxidase (GSH-Px) was increased in the pre-vaccination period and from baseline at Day 56 with UP446 supplementation (p ≤ 0.0270).ConclusionThese results suggest a 56-day supplementation with UP446 was beneficial in mounting a robust humoral response following vaccination. Increasing GSH-Px in the pre-vaccination period may help improve antioxidant functions and potentially mitigate the oxidative stress induced following vaccination.

Published
2023
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44. Coenzyme Q10

Author

Guthrie, Najla, primary, Vachon, Darrell, additional, and Chaturvedi, Pratibha, additional

Published
2006
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48. Inhibition of proliferation of estrogen receptor-negative MDA-MB-435 and -positive MCF-7 human breast cancer cells by palm oil tocotrienols and tamoxifen, alone and in combination

Author

Guthrie, Najla, Gapor, Abdul, Chambers, Ann F., and Carroll, Kenneth K.

Subjects
Tamoxifen -- Physiological aspects, Palm oil -- Health aspects, Estrogen -- Antagonists, Breast cancer -- Physiological aspects, Food/cooking/nutrition
Abstract

Tocotrienols are a form of vitamin E, having an unsaturated isoprenoid side-chain rather than the saturated side-chain of tocopherols. The tocotrienol-rich fraction (TRF) from palm oil contains [Alpha]-tocopherol and a mixture of [Alpha]-, [Gamma]- and [Delta]-tocotrienols. Earlier studies have shown that tocotrienols display anticancer activity. We previously reported that TRF, [Alpha]-, [Gamma]- and [Delta]-tocotrienols inhibited proliferation of estrogen receptor-negative MDA-MB-435 human breast cancer cells with 50% inhibitory concentrations ([IC.sub.50]) of 180, 90, 30 and 90 [[micro]gram/mL, respectively, whereas [Alpha]-tocopherol had no effect at concentrations up to 500/[[micro]gram]/mL. Further experiments with estrogen receptor-positive MCF-7 cells showed that tocotrienols also inhibited their proliferation, as measured by [3H] thymidine incorporation. The [IC.sub.50s] for TRF, [Alpha]-tocopherol, [Alpha]-, [Gamma]- and [Delta]-tocotrienols were 4, 125, 6, 2 and 2 [[micro]gram]/mL, respectively. Tamoxifen, a widely used synthetic antiestrogen inhibits the growth of MCF-7 cells with an [IC.sub.50] of 0.04 [[micro]gram]/mL. We tested 1:1 combinations of TRF, [Alpha]-tocopherol and the individual tocotrienols with tamoxifen in both cell lines. In the MDA-MB-435 cells, all of the combinations were found to be synergistic. In the MCF-7 cells, only 1:1 combinations of [Gamma]- or [Delta]-tocotrienol with tamoxifen showed a synergistic inhibitory effect on the proliferative rate and growth of the cells. The inhibition by tocotrienols was not overcome by addition of excess estradiol to the medium. These results suggest that tocotrienols are effective inhibitors of both estrogen receptor-negative and -positive cells and that combinations with tamoxifen should be considered as a possible improvement in breast cancer therapy. KEY WORDS: * tocotrienols * tamoxifen * breast cancer * MCF-7 * MDA-MB-435

Published
1997

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