Caliper Ingredients commissioned Colorado State University (CSU) to conduct a clinical study of commercially available CBD-infused food and supplement product pharmacokinetics.
Pharmacokinetics looks at how bioactives diffuse through the body, highlighting the difference between what is consumed and what is absorbed, as well the rate and efficiency of absorption.
"More than 20 million Americans use CBD daily, and trends show that number continuing to rise," said Christopher Bell, PhD, lead researcher with the CSU team. "But there is so little we understand about CBD, and how everything from product format to individual physiology can affect circulating blood concentrations over time. The industry simply lacks basic scientific research and substantiation. We partnered with Caliper because they share our drive to better understand CBD and its effects on the human body, which was why testing with humans—and publishing the results in a peer-reviewed journal — was essential."
The research, published in a special edition of Pharmaceuticals titled Cannabidiol: Advances in Therapeutic Applications and Future Perspectives, was approved by an Institutional Review Board (IRB) in compliance with the requirements of 45 CFR 46 for human clinical research.
Study details
Researchers compared the pharmacokinetic profiles of three proprietary soluble CBD formats against two control formats.
Conducted by CSU research scientists, this blinded, randomized, crossover study design included 15 healthy men and women, 21-62 years of age, with each participant consuming 30mg of CBD in five product formats. Three of Caliper's proprietary dissolvable CBD formulations were tested against two controls: a standardized, oil-based CBD tincture and a CBD isolate, which together represent the two of the more common CBD product formats available to consumers today. Participants provided intravenous blood samples prior to ingestion, and then at regular intervals over the ensuing four hours.
Findings
Blood analysis revealed that all of Caliper's product formats were absorbed faster than either control:
Caliper 5% CBD Liquid Concentrate (SKU: T-L-A-5), delivered CBD into the bloodstream 424 times faster than isolate, and 64 times faster than tincture, in the 30 minutes following ingestion, based on a comparison of observed circulating blood levels of CBD.
Caliper 20% CBD Liquid Concentrate (SKU: T-L-Q-20), delivered CBD into the bloodstream 218 times faster than isolate, and 33 times faster than tincture, in the 30 minutes following ingestion, based on a comparison of observed circulating blood levels of CBD.
Caliper 5% CBD Powder (SKU: T-P-S-5), delivered CBD into the bloodstream 142 times faster than isolate, and 22 times faster than tincture, in the 30 minutes following ingestion, based on a comparison of observed circulating blood levels of CBD.
The power of research
"Caliper's mission is to make consistent, convenient, and useful CBD products that feature rapid uptake and superior bioavailability — and we back it all up with rigorous clinical research. This study validates that mission," said Nicole Maione, general manager of Caliper Consumer. "The CBD industry has unfortunately invested far more money into the promotion of unfounded marketing claims than into the research required to substantiate those claims. Caliper cares about the process as much as the data, and we want to move this industry forward by developing clinically-substantiated CBD-infused products that meet their label claims."
Jolene Jacobs, General Manager of Caliper Ingredient, said "It is critical to our ingredient customers and to their consumers that the ingredients in their products are not only safe, but true to their claims. Our customers' investment in the products they have developed, and the brand loyalty they have built, is one of many reasons we believe that formulation matters — and why we have invested heavily in a well-designed clinical study from a credible academic source.”
CBD uncertainty
"Caliper has spent considerable time and energy battling charlatanism in the the CBD marketplace, including lobbying the FDA and Congress to place a higher priority on CBD and proactively implement measures that will hold manufacturers to the same standards for labeling accuracy, manufacturing controls, and claims substantiation as non-CBD food & supplement products,” added Jacobs.
According to the company, Caliper will continue to hold itself to the same stringent regulations and standards in product research, development, and manufacturing that the FDA expects of non-CBD food and supplement manufacturers.
Dosing
PK studies are critical to understanding the efficacy of any bioactive compound, and while the authors noted that they couldn’t make definitive recommendations, they do suggest that their findings help highlight the importance of guidelines on dosing — something the FDA may implement in the future.
“The implication is that future dosing guidelines may better serve users of CBD when additional consideration is given to expected rates of CBD absorption based on preparation/formulation characteristics (e.g., presence/absence of ingredients used to promote solubility), requirements of intended use (e.g., acute needs from a single dose vs. chronic repeated dosing), and the body size and composition of the user. Dosing guidelines should be a focus of future research as we are unable to make definitive recommendations based on our current data,” the authors noted in the report.
Source: Pharmaceuticals
2021, 14(1), 35; https://doi.org/10.3390/ph14010035
“Comparison of Five Oral Cannabidiol Preparations in Adult Humans: Pharmacokinetics, Body Composition, and Heart Rate Variability”
Authors: N. Bondareva Williams et al.
