Sean Moloughney, Editor02.09.21
In collaboration with Colorado State University (CSU), Caliper Foods, a manufacturer and supplier of soluble hemp-derived cannabinoids, has completed a human clinical study on 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 (PK) 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. PK studies are critical to understanding the efficacy of any bioactive compound, including CBD, since a bioactive’s effect is a function of its presence. In other words, you can’t feel what you don’t absorb. PK 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 on mouse studies or analogies to non-cannabinoid bioactives (often curcumin). Caliper said its 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, this study is unique in its academic integrity, the company said. 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.
The blinded, randomized, crossover study design involved 15 healthy men and women, ages 21-62, each consuming 30 mg of 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, according to the company:
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 (SKU: T-L-A-5), which is used in 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 (SKU: T-L-Q-20), which is used in a range 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. 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.”
"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. 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,” said Jolene Jacobs, general manager of Caliper Ingredients. “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.”
Caliper has been lobbying the FDA and Congress to regulate CBD and other hemp-derived cannabinoids. For example, Caliper has been urging FDA to hold cannabinoid manufacturers to the same baseline standards for labeling accuracy, good manufacturing practices, and claims substantiation that non-CBD food & supplement manufacturers have operated under for decades.
“In their well-meaning search for better data and real world evidence, the FDA has unfortunately opted for delaying the regulatory process time and again in the alleged pursuit of enacting perfect regulation in the future over the necessity of enacting basic regulation today. The regulatory delay has, and will continue to, endanger consumers,” said Justin Singer, CEO of Caliper Foods. “We agree that real world evidence is important, which is why we’ve long urged the FDA to impose the same labeling and manufacturing requirements on hemp product manufacturers as they do on other foods and supplements. You can’t trust consumer reports of CBD usage unless you can trust the veracity of the labels on the products.”
Dr. Christopher Bell from Colorado State University noted than some estimates indicate more than 20 million Americans use CBD daily. "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."
This study was approved by an Institutional Review Board (IRB) in compliance with the requirements of 45 CFR 46 for human clinical research.
Pharmacokinetics (PK) 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. PK studies are critical to understanding the efficacy of any bioactive compound, including CBD, since a bioactive’s effect is a function of its presence. In other words, you can’t feel what you don’t absorb. PK 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 on mouse studies or analogies to non-cannabinoid bioactives (often curcumin). Caliper said its 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, this study is unique in its academic integrity, the company said. 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.
The blinded, randomized, crossover study design involved 15 healthy men and women, ages 21-62, each consuming 30 mg of 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, according to the company:
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 (SKU: T-L-A-5), which is used in 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 (SKU: T-L-Q-20), which is used in a range 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. 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.”
"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. 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,” said Jolene Jacobs, general manager of Caliper Ingredients. “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.”
Caliper has been lobbying the FDA and Congress to regulate CBD and other hemp-derived cannabinoids. For example, Caliper has been urging FDA to hold cannabinoid manufacturers to the same baseline standards for labeling accuracy, good manufacturing practices, and claims substantiation that non-CBD food & supplement manufacturers have operated under for decades.
“In their well-meaning search for better data and real world evidence, the FDA has unfortunately opted for delaying the regulatory process time and again in the alleged pursuit of enacting perfect regulation in the future over the necessity of enacting basic regulation today. The regulatory delay has, and will continue to, endanger consumers,” said Justin Singer, CEO of Caliper Foods. “We agree that real world evidence is important, which is why we’ve long urged the FDA to impose the same labeling and manufacturing requirements on hemp product manufacturers as they do on other foods and supplements. You can’t trust consumer reports of CBD usage unless you can trust the veracity of the labels on the products.”
Dr. Christopher Bell from Colorado State University noted than some estimates indicate more than 20 million Americans use CBD daily. "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."
