‘Seminal findings’: First report of safety and efficacy of hemp-derived, CBD-rich extract in healthy humans

By Stephen Daniells contact

- Last updated on GMT

Supplementation with a hemp-derived, CBD-rich extract for six weeks led to significant improvements in sleep and reductions in appetite, according to results of a randomized clinical trial in healthy adults.

Findings from the study, which used CV Sciences’ PlusCBD Oil, were presented for the first time at the 16th Annual Conference of the International Society of Sports Nutrition (ISSN) in Las Vegas, June 13-15.

Led by Hector Lopez, MD, chief medical officer at the Center for Applied Health Sciences, the study found that 60 mg per day of PlusCBD Oil containing 15 mg of hemp-derived CBD for six weeks led to significant decreases in appetite, along with improvements in sleep quality and duration, and enhancements in “quality of life” scores.

“These data represent the first report we are aware of regarding the safety and efficacy of a commercially available finished product (PlusCBD Oil) containing a hemp-derived, CBD-rich extract in healthy humans,” ​wrote the researchers on their poster.

“Collectively, these seminal findings in healthy subjects indicate that six weeks of hemp PlusCBD Oil supplementation can improve measures of sleep homeostasis, reduce appetite, and enhance quality of life.”

Dr Lopez confirmed that he plans to submit a more comprehensive manuscript including some of the areas they pointed out in the conclusion/ future directions part of the poster.  

Duffy MacKay, ND, senior vice president of scientific and regulatory affairs for CV Sciences, told us the company is "excited to make an additional contribution to the body of science underpinning PlusCBD Oil.

"We previously conducted and published the first toxicology studies​ to establish the safety of our hemp extract. In addition to having our products used in published clinical case reports on patients with anxiety, depression, and PTSD. Now, we are proud to be part of the first ever placebo-controlled, double-blind study of a hemp CBD product in healthy people."

“Unprecedented”

Interest in cannabis and hemp-derived cannabidiol (CBD) has never been higher. While the 2018 Farm Act did remove hemp from the definition of marijuana under the Controlled Substances Act​, the FDA has consistently stated that CBD is not a legal ingredient for use in dietary supplements, foods and beverage.

Despite this stance, there are estimated to be 1,500 CBD products in the marketplace. .

“This is an unprecedented industry,” ​Dr Lopez told attendees during his ISSN presentation. “We thought we saw it with omega-3 and probiotics, but this is surpassing everything.

“Scientifically there’s still an enormous amount for us to discover.”

Speaking with NutraIngredients-USA, Dr Lopez said: “In the future were going to start seeing products within the space that are targeting one of the three legs of the stool [that make up the endocannabinoid system]. They’re either going to be targeting endogenous cannabinoids synthesis or breakdown; they’re going to be trying to activate or inhibit or mitigate the activation of the endocannabinoid system, and that could be through going after receptors, the endocannabinoids themselves, or the enzymes responsible for breaking them down.

“You also have these phytocannabinoids, which are going to be natural product derived bioactives that are targeting the endocannabinoid system exogenously.”

In the video above, Dr Lopez gives an extensive overview of the endocannabinoid system (ECS) and how modulation of the ECS could perhaps impact human performance.

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