Wellness brand Prospect Farms and health tech company Radicle Science recently announced the launch of an observational study to scientifically evaluate and research the impact of CBD on sleep.
“To be clear, we aren’t just running some of the first human [sleep] studies on CBD,” said Pelin Thorogood, co-founder & executive chair of Radicle Science. “We are completely re-imagining the approach to clinical research to make it more convenient, diverse, inclusive and valuable to the folks in the study. Essentially, we believe our direct to consumer (D2C) study model will deliver even better insights than traditional research, given the much-improved reach and ability to scale.”
The research aims to investigate the impact of Prospect Farms' Dream Tincture on user reported duration and quality of sleep when taken consistently each night. The tincture is a full-spectrum hemp extract derived from organically-grown hemp, a blend of naturally derived terpenes, including Linalool (a component of lavender) and Myrcene, as well as an antioxidant blend of avocado, olive and grapeseed carrier oils.
The 4-week longitudinal observational study will collect data on CBD dosing, administration frequency, user demographics, behaviors and beliefs, efficacy across multiple conditions, and potential predictors and modifiers of treatment response. About 200 people are expected to participate.
The participant data will be collected by Radicle Science in a virtual, direct to consumer, crowdsourced fashion. Upon collection, Radicle Science biostatisticians and data scientists will analyze the data, looking for hidden correlates and variables that are predictors or modifiers of health outcome.
Some examples of the organizers hope they can learn includes:
- What dose of CBD consumed is correlated with the greatest improvement in sleep outcome?
- Are there specific demographics such as gender, ethnicity, age that are predictive of response to CBD?
- How do concurrent caffeine, alcohol, dietary supplement or cannabis consumption affect measured health outcomes?
- Which specific subtypes of sleep mood, or pain issues see the greatest index change with initiation of CBD consumption?
- How are concurrent changes in sleep, mood and pain correlated or modulated with one another?
“Just as importantly, we saw this as a unique opportunity to bring much needed equity and diversity into medical research. The unprecedented scale and reach of our studies finally enables 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,” said Radicle Science co-founder Dr. Jeffrey Chen, MBA.
According to Thorogood, the company leverages a proprietary data analytics platform and a virtual, direct-to-consumer model to deliver objective health outcome data across diverse populations and conditions.
“Our front end includes a sophisticated, logic-driven, participant questionnaire creation, automation, and distribution technology to collect data directly from large numbers of consumers, and can reach them on their phones and computers, mobile or web browsers, and via email or text SMS. Our backend consists of a cloud-based data lake framework that enables massive quantities of data storage, ad-hoc analysis, and visualization. Over time, we plan to seamlessly enrich our Patient Reported Outcome (PRO) data with streaming data from wearable devices, electronic health records (EHR), genetic data and insurance claim records to offer consumers even greater insights about their health,” Thorogood explained.
Dreaming outside the box
Radicle said they are working to create a world where physicians recommend natural health products as often as current western medicines. “From the dawn of civilization until the 20th century, all our medicines were naturally-occurring and plant-based. ‘Radicle’ is the scientific term for the first root to emerge from a plant, and Radicle Science is looking to bring western medicine back to the roots of mankind's original medicines,” said Chen.
The company hopes to plummet the cost and time of research by avoiding federal funding restrictions, bypassing institutional bureaucracy, eliminating physical infrastructure, and running studies virtually to generate rigorous data on natural health products.
Enrollment for the Sleep Study closes on April 28. For more information about the sleep study or to enroll visit dreamstudy.prospectfarms.com.
Sleep and a healthy immune system go hand-in-hand, so how can consumers improve their sleep and, as a result, support their own immune systems? Join NutraIngredients-USA on May 5 for a webinar that will examine the scientific links between sleep and immune function, and then explore which ingredients are best positioned to deliver a good night’s sleep. To learn more and to register for this event, click here.