Pelin Thorogood, President and Co-founder of Wholistic Research & Education Foundation and Co-founder and Executive Chair of Radicle Science shares the findings of the first-ever study to focus exclusively on CBD’s potential to support women’s health and wellness, alongside Angie Tebbe, Co-founder and CEO of women-led brand Rae Wellness. Pelin Thorogood also serves as Chief Health and Research Contributor for Svn Space.
1. What is unique and exciting about this new study, and why is it important for today's consumer?
Pelin Thorogood: Cannabis in general is likely the most widely used yet least understood plant medicine in the world. While there are thousands of CBD brands being used by tens of millions of Americans, there is virtually no data on which formulations, used in what manner, for which types of individuals, may offer the most benefit. This pioneering study Radicle Science conducted in partnership with Wholistic Research & Education Foundation, OpenNest Labs, and the women-led brand Rae Wellness is the largest randomized, controlled study on the effects of commercially available CBD products and has the potential to inform future research and industry standards for CBD products. Perhaps even more groundbreaking, it’s the first-ever study focused exclusively on cannabidiol’s potential to support women’s health and wellness, an often-underrepresented population in scientific research. We’re hopeful the findings of this 1350 women study can help consumers better understand which products and usage patterns might work best for their individual needs. We see this study serving as a promising starting point for the entire industry to begin generating robust scientific data on over-the-counter CBD products.
Angie Tebbe: At Rae, we're fundamentally dedicated to supporting all consumers – especially underrepresented individuals – to feel their best from the inside out through a holistic universe of supplements that are effective, evidence-based, and attainably-priced. And the philosophy behind the launch of our hemp-derived supplements is no different. While existing studies suggest that cannabidiol has considerable potential to support wellness, there was a glaring gap in research dedicated to guiding effective product development. That's why we collaborated with the renowned medical experts and data scientists at Radicle Science to better understand CBD's potential as an ingredient and, in particular, its effect on women.
2. Tell us more about the study design and specific goals?
Pelin Thorogood: In Q4 2020, 1350 females aged 24-44 from across the US were recruited to participate in a 60-day in-home use test comparing the effects of 8 different CBD formulations from Rae Wellness across well-being, mental health, physical health, digestive health, sleep quality, and sexual satisfaction. 1218 completed the 60-day study. The primary study goals were to assess (1) whether women randomized to any CBD product during the 60 day period experienced improvements across a range of health domains compared to the no-treatment control group, and (2) whether there were any differences in performance between the different CBD products.
Angie Tebbe: When developing all of our supplements, our goal is simple: create effective, consistent and high-quality yet affordable formulations that benefit consumers and shine in a category full of over-priced alternatives of questionable quality As we expanded into hemp-derived supplements, we wanted leveraged rigorous research to develop single-strain formulas that include certified-organic ingredients and are surrounded with robust testing. We aim to set the industry standard for CBD products by bringing high-quality, evidence-based formulations alongside attainable prices to market.
3. What are some of the findings of this groundbreaking study?
Our recently released whitepaper details the results of the Phase 1 analysis of the IRB-reviewed study data, organized into four categories: (1) Effects of CBD, (2) Formulation, (3) Dosage, and (4) Mode of Delivery. The primary takeaway of the study is that individuals who consume as little as 15 mg of CBD daily could realize substantial reductions in anxiety within 30 days of use and these reductions were sustained for up to 60 days with continued consumption.
Mean change in anxiety score throughout time by product group
4. Were there any unexpected results?
Pelin Thorogood: We did not find evidence of the so-called entourage effect (i.e., the theory that compounds such as CBD and THC exhibit synergistic effects when taken together), suggesting some full-spectrum (up to 0.3% THC) hemp-derived CBD products may perform similarly to broad-spectrum (0% THC) CBD products for anxiety reduction. Note that THC is just one component that could theoretically drive the so-called entourage effect, thus the study is just scratching the surface of the combinatorial effects of the hundreds of cannabis compounds. Our results also suggest that, for comparable populations who consume these CBD products, similar reductions in anxiety could be realized regardless of whether the mode of delivery was oil or capsule. There is of course more research needed to further validate these interesting findings.
5. How did Rae Wellness leverage these findings for their product development?
Angie Tebbe: The study findings further supported our commitment to delivering pure and powerful supplements that are always attainably priced. Our new hemp-derived supplements are available at raewellness.co for $39.99.
6. What’s next for this groundbreaking study?
Pelin Thorogood: As a part of our Phase II analysis of the Rae dataset, which will be released in Fall of 2021, we’ll evaluate the impact of CBD consumption on other physical and mental health domains such as well-being, pain, digestive health, sleep quality, and sexual satisfaction. Given my interest in precision medicine, I am also excited to dive deeper into specific factors that may impact or be predictive of the effects of CBD on various health domains. It will be interesting to explore how demographic variations, such as ethnicity, as well as behavioral factors, such as variations in time of day the products were consumed, may impact CBD efficacy.
7. Please tell us more about the healthtech B-corp Radicle Science that’s behind this study and the collaboration with Wholistic Research & Education Foundation, OpenNest Labs and Rae Wellness.
Pelin Thorogood: As we’ve discussed before, I co-founded Wholistic Research and Education Foundation over four years ago to bring private money and resources to fund much-needed cannabis research. While we’ve powered groundbreaking work at some of the top academic research institutes, federal regulations have thus far prevented us from studying non-prescription CBD products. To be honest, I have a very hard time with this given these CBD products are being used by literally tens of millions of Americans! Given my deep background in Big Data & analytics, the other issue for me is the small size of traditional trials. I realize this is a cost issue, as when adding each additional participant in a trial literally comes at a price tag of several tens of thousands, research institutions have to limit recruitment size and have to be very picky about who to allow in. The unfortunate consequence is that we don’t get enough data points from such small trials to power personalized recommendations, limiting their relevance for real-world heterogeneous populations. As a serial entrepreneur, I just knew there had to be a better way…which is why I joined forces with fellow rebel-with-cause Jeff Chen MD/MBA, the founder of the UCLA Cannabis Research Initiative,. We co-founded Radicle Science to drive down the cost and time of research by more than 10x, while still generating rigorous health data. That’s what we call democratizing natural medicine research. We also see our approach as a unique opportunity to bring much needed equity and diversity into clinical trials. The unprecedented scale and reach of our studies finally enable inclusion of diverse ethnicities, genders, age groups, behavioral habits, and pre-existing health conditions to move us closer to personalized medicine for the population at large.
Given our history, Wholistic Research is naturally a founding partner of Radicle and a collaborator in this study. OpenNest Labs is another such key founding partner. As a venture studio that advises the next generation of cannabis brands, they have a deep commitment to furthering industry standards based on data. And of course, we couldn't be more pleased to partner with Rae to guide their product development given their dedication to enter the hemp-derived CBD industry with a desire to bring high-quality, evidence-based formulations to the market.