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Abstract
We determined the effects of a commercially available, GRAS (Generally Recognized As Safe) by independent conclusion, CBD-containing hemp oil extract on stress resilience, perceived recovery, mood, affect, body composition, and clinical safety markers in healthy human subjects.
Methods: Using a randomized, placebo-controlled, double-blind design, 65 overweight, but otherwise healthy men and women (35.2 ± 11.4 years, 28.5 ± 3.3 kg/m2) ingested either Hemp Oil Extract [Hemp, 60 mg/d PlusCBDTM Extra Strength Hemp Extract Oil (15 mg hemp-derived CBD)] or a placebo (PLA) every day for six weeks while continuing to follow their normal diet and physical activity patterns. Outcome variables included changes in stress resilience, a 14-item panel of various psychometric parameters, heart-rate variability, plasma chromogranin A, body composition, and general markers of health. Data were analyzed using mixed factorial ANOVA, t-tests with 95% confidence intervals, and effect sizes (ES).
Results: HDL cholesterol significantly improved in the Hemp group (p = 0.004; ES = 0.75). No other statistically significant group x time interaction effects were observed. Statistical tendencies for between-group differences were found for ‘I Get Pleasure From Life’ (p = 0.06, ES = 0.48) and ‘Ability to Cope with Stress’ (p = 0.07, ES = 0.46). Sleep quality (Hemp, p = 0.005, ES = 0.54) and sleep quantity (Hemp, p = 0.01, ES = 0.58) exhibited significant within-group changes. All values for hepato-renal function, cardiovascular health, fasting blood lipids, and whole blood cell counts remained within normal clinical limits with no between-group differences over time being identified.
Conclusions: Hemp supplementation improved HDL cholesterol, tended to support psychometric measures of perceived sleep, stress response, and perceived life pleasure and was well tolerated with no clinically relevant safety concerns. Registered at clinicaltrials.gov: NCT04294706.
Acknowledgements
The supplement (PlusCBD Extra Strength Hemp Extract Oil™), placebo, and funding for this project was received through a restricted external grant from CV Sciences, Inc. The authors would like to thank the study participants who completed the study protocol. Publication of these results should not be considered as an endorsement of any product used in this study by the Center for Applied Health Sciences or any of the organizations where the authors are affiliated.
Declaration of interests
Lopez was previously remunerated with stock options as a consultant for CV Sciences, serving on the scientific advisory board from 2014 through 2018. Lopez is an officer and member of The Center for Applied Health Sciences, a privately held contract research organization that has received external funding from companies that do business in the dietary supplement, natural products, medical foods and functional foods and beverages industries. He is the co-founder and member of Supplement Safety Solutions, LLC., serving as an independent consultant for regulatory compliance, safety surveillance and Nutravigilance to companies in the dietary supplement and functional foods industry, but not the sponsor of the current research. Lopez is also co-inventor on multiple patent applications within the field of dietary supplements, applied nutrition and bioactive compounds. Raub, Cesareo, Kedia, and Sandrock all report no conflicts of interest. Kerksick has no conflict in terms of financial or business interests related to this product. Kerksick has received external grant funding from companies that do business in the nutrition and sports nutrition sectors. He has received compensation to speak and prepare scientific manuscripts including white papers and marketing copy on topics related to sports nutrition. He has and continues to serve in advisory roles to various sport nutrition and nutrition companies. Ziegenfuss is an officer and member of The Center for Applied Health Sciences, a privately held contract research organization that has received external funding from companies that do business in the dietary supplement, natural products, medical foods and functional foods and beverages industries. Ziegenfuss was previously remunerated with stock options as a consultant for CV Sciences, serving on the scientific advisory board from 2014 through 2018. Ziegenfuss has received grants and contracts to conduct research on dietary supplements; has served as a paid consultant for industry; has received honoraria for speaking at conferences and writing articles about functional foods and dietary supplements; receives royalties from the sale of several sports nutrition products (none related to the product examined in the present study); and has served as an expert witness on behalf of the plaintiff and defense in cases involving dietary supplements. Ziegenfuss is also co-inventor on multiple patent applications within the field of dietary supplements, applied nutrition and bioactive compounds.
Authors’ contributions
HLL and TNZ designed the study, secured funding for the project, and assisted with manuscript preparation. BR, KC, and JS carried out subject recruitment, data collection, coordination of the study and compliance. AWK provided medical oversight and screened subjects. CMK performed the data analyses/interpretation and prepared the manuscript. All authors read and approved the final manuscript.
Additional information
Funding
Notes on contributors
Hector L. Lopez
Hector L. Lopez, MD, MS is CMO and Founding Partner of The Center for Applied Health Sciences and Supplement Safety Solutions, USA. Sports Medicine, Regenerative Medicine, Endocrinology & Metabolism. Interested in nutritional biosciences, and the effects of naturally occurring bioactives on health, human performance and longevity.
Kyle R. Cesareo
Kyle R. Cesareo, MS, CCRC is a Clinical Research Assistant, The Center for Applied Health Sciences. He is also a Certified Strength & Conditioning Specialist with interests in sports performance, dietary supplements and nutrition. Ohio, USA.
Betsy Raub
Betsy Raub, RN, BSN is a clinical research nurse and lab coordinator at The Center for Applied Health Sciences. Additionally, with 20 years of critical care experience, she continues to remain relevant at the bedside at Aultman Alliance Community Hospital, Ohio, USA.
A. William Kedia
A. William Kedia, MD is a Medical Advisor to The Center for Applied Health Sciences, Ohio, USA.
Jennifer E. Sandrock
Jennifer E. Sandrock, MS, RD, CCRC is the COO of The Center for Applied Health Sciences. She is also the Registered Dietitian and Clinical Research Coordinator for all studies conducted at CAHS.
Chad M. Kerksick
Chad M. Kerksick, PhD is an Associate Professor of Exercise Science in the Exercise Science department in the School of Health Sciences at Lindenwood University and Director of the Exercise and Performance Nutrition Laboratory. His primary research interests include sport nutrition as well as the biochemical, cellular and molecular adaptations relative to various forms of exercise and nutrition interventions.
Tim N. Ziegenfuss
Tim N. Ziegenfuss, PhD is the CEO of The Center for Applied Health Sciences and past President (2009-2011) and Fellow of the International Society of Sports Nutrition. His primary research interests are applied physiology, dietary supplements, nutrition, and sports medicine.