Radicle Clarity™ RBB: Testing a wellness product for cognitive function and related health outcomes
Radicle Clarity™ RBB: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of Health and Wellness Products on Cognitive Function and Related Health Outcomes
NA · Radicle Science · NCT07245784
This trial tests whether taking the Clarity wellness product improves thinking, memory, and related health measures in adults living in the United States.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 850 (estimated) |
| Ages | 21 Years to 105 Years |
| Sex | All |
| Sponsor | Radicle Science (industry) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Del Mar, California) |
| Trial ID | NCT07245784 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled trial enrolling adults in the United States to compare an active Clarity product with a matching placebo over a 13-week period. All data are collected remotely through electronic self-reported surveys at baseline, during product use, and at a final assessment, with no in-person visits. Participants must be at least 21 years old, willing to take the product without knowing whether it is active or placebo, and meet safety criteria that exclude known cardiac, liver, or kidney disease and certain medication or pregnancy-related risks. The study focuses on patient-reported cognitive outcomes and related health indicators in a real-world, home-based setting.
Who should consider this trial
Good fit: Ideal candidates are U.S. adults aged 21 or older who report cognitive concerns, are willing to take a study product without knowing its identity, and have the potential for at least a 30% improvement in their primary outcome.
Not a fit: People with known cardiac, liver, or kidney disease, heavy drinkers, pregnant or breastfeeding individuals, or those taking contraindicated medications are excluded and therefore may not benefit from participation.
Why it matters
Potential benefit: If successful, the product could provide a convenient, non-prescription option to help some adults improve cognition and related aspects of wellbeing.
How similar studies have performed: Previous trials of dietary supplements and wellness products for cognition have produced mixed results, with some small studies showing modest benefit and others finding no clear effect.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Participants must meet all the following criteria: * Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities * Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed * Resides in the United States * Has the opportunity for at least 30% improvement in their primary health outcome * Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study 3.2 Exclusion Individuals who report any of the following during screening will be excluded from participation: * Report being pregnant, trying to become pregnant, or breastfeeding * Unable to provide a valid US shipping address and mobile phone number * Reports current enrollment in another clinical trial * Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) * Unable to read and understand English * Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk. * Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients. * NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure * Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients. * Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products * Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products * Lack of reliable daily access to the internet
Where this trial is running
Del Mar, California
- Radicle Science Inc. — Del Mar, California, United States (RECRUITING)
Study contacts
- Principal investigator: Susan Hewlings — Radicle Science
- Study coordinator: Study Manager
- Email: studymgmt@radiclescience.com
- Phone: 858-779-0086
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cognitive Function