Impact of a Novel Brain Longevity Supplement Containing the Postbiotic Urolithin A (Mitopure) on Cognitive Function and Related Health Outcomes
NCT ID: NCT07060898
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
650 participants
INTERVENTIONAL
2025-07-29
2025-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Active
Novel nutritional product (containing Mitopure Urolithin A) targeting improvements in cognitive health
Active Product
Novel Nutritional Product targeting Cognition
Placebo
Identical Placebo product
Placebo Product
Identical placebo product
Interventions
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Active Product
Novel Nutritional Product targeting Cognition
Placebo Product
Identical placebo product
Eligibility Criteria
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Inclusion Criteria
* Adults, at least 40 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
o 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 Criteria
* 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.
o 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.
o 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
40 Years
ALL
Yes
Sponsors
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Radicle Science (sponsor)
UNKNOWN
Amazentis SA
INDUSTRY
Responsible Party
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Principal Investigators
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Susan Hewlings, PhD
Role: PRINCIPAL_INVESTIGATOR
Radicle Science Inc.
Locations
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Radicle Science, Inc Office
Encinitas, California, United States
Countries
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Related Links
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Radicle Science, Inc
Other Identifiers
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RADX-SP-2506_RAM
Identifier Type: -
Identifier Source: org_study_id