Health and wellness product for improving mental clarity
Radicle Clarity DSTTM: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Mental Clarity and Related Health Outcomes
This trial will test a daily health and wellness product against a placebo to see if it improves mental clarity in U.S. adults ages 35 to 60.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 990 (estimated) |
| Ages | 35 Years to 60 Years |
| Sex | All |
| Sponsor | Radicle Science Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Del Mar, California) |
| Trial ID | NCT07342192 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled, direct-to-consumer study enrolls U.S. adults aged 35–60 and assigns participants to either an active product or a placebo. Participants self-report health indicators electronically over a 12-week active product period with no in-person visits. Eligible participants must accept not knowing which product they receive and will be screened for exclusions such as serious cardiac, liver, or kidney disease, pregnancy, heavy alcohol use, or contraindicated medications. All assessments and data collection are conducted remotely via mobile devices and require a valid U.S. shipping address.
Who should consider this trial
Good fit: Ideal candidates are U.S. residents aged 35–60 who can consent electronically, are willing to take an unknown study product, and do not have major cardiac, liver, or kidney disease, pregnancy, heavy alcohol use, or contraindicated medications.
Not a fit: People who are pregnant or breastfeeding, heavy drinkers, have serious heart/liver/kidney disease, or take contraindicated medications may not benefit or may be excluded.
Why it matters
Potential benefit: If effective, the product could offer a convenient, non-prescription way to improve mental clarity for middle-aged adults.
How similar studies have performed: Prior research on consumer wellness products for cognitive function is mixed and generally limited, so similar approaches have shown variable and often modest results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Participants must meet all the following criteria: * Adults, 35-60 years of age (inclusive) 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 Exclusion Individuals who report any of the following during screening may 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 at a 7th grade level * 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 and/or pose a safety risk * Lack of reliable daily access to the internet * Reports current use of prescription medication(s) for cognitive enhancement * Reports current regular cannabis use
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.