The study, “Effects of Hemp Extract on Markers of Wellness, Stress Resilience, Recovery and Clinical Biomarkers of Safety in Overweight, But Otherwise Healthy Subjects,” was recently published in the Journal of Dietary Supplements.
Background
The authors note that both endogenous cannabinoids and phytocannabinoids as well as synthetic agents that act on the endocannabinoid system have the potential to impact anxiety and stress disorders, immune function, chronic pain and musculoskeletal conditions, mood regulation or depression, insomnia or sleep quality, and appetite signaling/food intake disorders. Despite the increase in interest and use of CBD products, very limited amounts of research are available that outline the safety of CBD-containing hemp extract supplementation.
The researchers also point out, “There is a dearth of human clinical data on its potential ability to impact various outcomes of interest such as changes in stress response, affect and mood, sleep hygiene, body composition, and clinical markers of health and safety. Searching the biomedical literature database PubMed (www.ncbi.nih. gov/pubmed/) for key words such as ‘cannabidiol, hemp extract, hemp oil, and hemp oil extract’ revealed no human investigations that have examined these outcomes.”
Researchers used PlusCBD products to determine their benefits on stress resilience, perceived recovery, mood, affect, body composition, and clinical safety markers in healthy human subjects.
The study
Using a randomized, placebo-controlled, double-blind design, 65 overweight, but otherwise healthy men and women ingested were matched according to gender and body mass index prior to being randomly assigned to one of two supplementation groups: placebo (olive oil) or hemp oil extract. Both groups were instructed to ingest one soft gel each day for six weeks.
Each soft gel delivered 60 mg/day of CBD-containing CO2 supercritical extract of aerial parts of hemp (PlusCBD Extra Strength Hemp Extract) which delivered 15 mg of hemp-derived CBD. The investigational product has been self-affirmed as a GRAS (Generally Recognized As Safe) CBD-containing hemp oil extract.
During this six-week period, the participants continued to follow their normal diet and physical activity routines. 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 Analysis of variance (ANOVA), t-tests with 95% confidence intervals, and effect sizes.
Findings
Six weeks of supplementing with CV Sciences test material led to improvements in high-density lipoprotein (HDL) cholesterol in overweight, yet healthy men and women. The report also highlighted that the CBD supported psychometric measures of perceived sleep, stress response, and perceived life pleasure and was well tolerated with no clinically relevant safety concerns.
Lead author Hector L. Lopez, M.D., CSCS, FAAPMR, FISSN noted, “In a first of its kind study, participants taking PlusCBD products had significant improvement in HDL cholesterol compared to placebo, while improvements in measures of stress response, life pleasure, wellness and sleep were also observed.” Lopez, a former consultant for CV Sciences, added, “We also found an excellent safety profile, with no adverse signals in liver or other biomarkers of health in the group treated with PlusCBD products.”
Sound science
Another recent study, also published in the Journal of Dietary Supplements, found a low rate of adverse effects in about 5 million consumers taking PlusCBD products over a two-year period. A noteworthy finding was the absence of any reports of liver toxicity, which has been described in studies using high doses of CBD as a prescription drug.
CV Sciences CEO Joseph Dowling said, “We continue to invest in clinical studies and aim to meet or exceed the high standards for safety that FDA and consumers demand. We are excited to be leaders in the CBD revolution and to help the category mature by publishing sound science.”
Source: The Journal of Dietary Supplements
27 May 2020 doi.org/10.1080/19390211.2020.1765941
“Effects of Hemp Extract on Markers of Wellness, Stress Resilience, Recovery and Clinical Biomarkers of Safety in Overweight, But Otherwise Healthy Subjects”
Authors: H. Lopez et al.