Hector L Lopez1, Tim N Ziegenfuss1, Kyle R Cesareo1, Betsy J Raub1, Jennifer E Sandrock1, Chad M Kerksick2
1The Center for Applied Health Sciences, Canfield, OH 44406, USA; 2Exercise and Performance Nutrition Laboratory, School of Health Sciences, Lindenwood University, St. Charles, MO, USA
Correspondence: Hector L Lopez (firstname.lastname@example.org)
The endocannabinoid system (ECS) is a master endogenous homeostatic system consisting of 1) lipid based signaling compounds (endocannabinoid ligands), 2) specialized cannabinoid receptors found throughout most tissues in the body and 3) biosynthetic and catabolic enzymes that regulate the endogenous ligands. Through both direct and indirect actions, endocannabinoids modulate and influence a variety of physiological systems, including pain, inflammation, thermoregulation, appetite, energy balance, muscle control/ coordination, sleep health, stress responses, motivation, mood, and memory. There is a wide variety of Cannabis sativa L. cultivars with a complex phytochemical profile containing terpenophenolic cannabinoids and 400+ constituents that are distinguished by their chemical and genetic profile. Hemp is generally characterized as a cultivar of C. sativa whose predominant cannabinoid is cannabidiol (CBD), with a relatively low level of delta-9 tetrahydrocannabinol (THC) when assayed on a dry weight basis. Herein, we report on the psychometric indices of sleep, appetite, quality of life, and biomarkers of safety from supplementation with a CBD containing supercritical CO2 extract of the aerial parts of hemp.
Materials and Methods
Using a randomized, placebo-controlled, double-blind design, 65 overweight, but otherwise healthy men (n = 32) and women (n = 33) (mean ± SD age, BMI: 35.2 ± 11.4 yr, 28.5 ± 3.3 kg/m2) ingested either Hemp Oil Extract [HEMP, 60 mg/d PlusCBD OilTM (15 mg hemp-derived CBD)] or a placebo (PLA) every day for six weeks before their evening meal. Subjects followed their normal diet and a routine of low intensity physical activity (30 min of walking exercise 5 days per week). Outcome variables included changes in stress resilience, a 14-item panel of various psychometric parameters, heart-rate variability (LF, HF, LF/HF ratio, rMSSD), plasma chromogranin A, body composition (lean mass, fat mass, bone mineral content, VAT fat via DEXA) as well as general markers of health (heart rate, blood pressure, and comprehensive clinical chemistry panels of serum and plasma) before and after six weeks of supplementation. Data were analyzed via ANOVA, t-tests (p<0.05) and effect sizes (ES).
Preliminary analyses revealed significant decreases in appetite (-6.2%, p=0.04, ES=0.22) and improvements in sleep quality (+22.0%, p=0.009, ES=0.54), sleep quantity (+21.3%, p=0.02, ES=0.58) and pleasure from life (+12.5%, p=0.006, ES=0.46) in HEMP only. All values for hepato-renal function (AST, ALT, BUN, creatinine, total bilirubin, alkaline phosphatase), cardiovascular health (heart rate, blood pressure), fasting blood lipids (cholesterol, triglycerides, HDL, LDL) whole blood cell counts (hemoglobin, hematocrit, RBC, MCV, MCH, MCHC, RDW, differential white cell counts) remained within normal clinical limits, and no between-group differences over time were noted.
Collectively, these seminal findings in healthy subjects indicate that six weeks of HEMP PlusCBD OilTM supplementation can improve measures of sleep homeostasis, reduce appetite, and enhance quality of life. Ongoing and future analyses will examine changes in stress resilience, autonomic nervous system function, body composition, inflammatory cytokines, adipokines, as well as targeted gene expression/transcriptome (NFkB, NLRP3, UCP, PGC1a), etc.
This study was funded in part by a research grant from CV Sciences Inc (Las Vegas, NV). HLL and TNZ are members of the Advisory Board of CV Sciences. The researchers in this study independently collected, analyzed, and interpreted the results without input from CV Sciences, Inc. All other authors declare no conflict of interest.