Caliper Foods, in conjunction with Colorado State University (CSU), has completed a clinical study of commercially available CBD-infused food and supplement product pharmacokinetics.
This study was approved by an Institutional Review Board (IRB) in compliance with the requirements of 45 CFR 46 for human clinical research.
Pharmacokinetics is the science of how bioactives diffuse through the body, and it reveals the difference between what we consume and what we absorb (vs. what we excrete), as well the rate and efficiency of absorption. Pharmacokinetics studies are critical to understanding the efficacy of any bioactive compound, including CBD, since a bioactive's effect is a function of its presence. Pharmacokinetics studies provide the scientific foundation for claims such as "fast acting," "long lasting," and "superior bioavailability."
To date, when CBD product manufacturers have claimed fast action or superior absorption, they have generally based those claims — to the extent they've predicated them at all — on mouse studies or analogies to non-cannabinoid bioactives (often curcumin). Caliper's study represents the first human clinical substantiation of such claims, as well as the first to do so using commercially available products and an IRB-approved study design.
Moreover, with the CBD industry generally mired in fraud and mistrust enabled by the prominent absence of Food & Drug Administration oversight or enforcement over the past four years, this study is unique in its academic integrity. Although Caliper provided funding for the study, Colorado State University exercised complete and independent authority over the collection, analysis and publication of these results.
Conducted by CSU researchers and published in a special issue of the medical journal Pharmaceuticals titled “Cannabidiol: Advances in Therapeutic Applications and Future Perspectives,” the study compared the pharmacokinetic profiles of three proprietary soluble CBD formats — Caliper Powder, Caliper Quillaia-based Liquid Concentrate, and Caliper Gum Arabic-based Liquid Concentrate — against two control formats: oil-based CBD tincture and unemulsified CBD isolate, which together power the majority of available consumer CBD products in use today.
The blinded, randomized, crossover study design involved 15 healthy men and women, ages 21-62, each consuming 30 mg CBD in each product format. Participants provided venous blood samples prior to ingestion, and then at regular intervals over the ensuing four hours. Blood analysis revealed that all of Caliper's product formats were absorbed significantly faster than either control:
Caliper Powder, which is used in Caliper's flagship consumer offerings, Caliper CBD and Caliper Swiftsticks, 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.
Caliper Gum Arabic-based Liquid Concentrate, which is used by Caliper Ingredients' customers to power a variety of beverage, food and supplement products, 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 Quillaia-based Liquid Concentrate, which is used by Caliper Ingredients' customers to power a variety of beverage, food and supplement products in the natural foods channel, 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'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,” said Nicole Maione, general manager of Caliper Consumer. “This study validates that mission. 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."
Caliper has expended considerable time and energy battling charlatanism in the CBD marketplace, including lobbying the FDA and Congress to demonstrate their concern for consumers by regulating the ongoing, widespread production and sale of consumer products infused with CBD and other hemp-derived cannabinoids. Caliper has taken the lead in pushing FDA to hold cannabinoid manufacturers to the same baseline standards for labeling accuracy, good manufacturing practices and claims substantiation that non-CBD food and supplement manufacturers have operated under for decades.
"It's incumbent upon our company, our industry and, above all, our regulatory agencies to ensure that consumer products meet the promises made on their labels,” said Jolene Jacobs, general manager of Caliper Ingredients. “That's why we invested heavily in a well-designed clinical study with a credible academic partner and supported its publication in an open access, peer-reviewed journal. We didn't conduct this study on mice in a lab. We used real people and real products and the results provide real-world support for our product claims. The fact that different product formats exhibited different absorption profiles demonstrates why brands need to base their claims on empirical data rather than empty buzzwords like 'nano' when talking about fast action or improved absorption."