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Clinical Trials in the USA / NCT07060898
Active, not recruiting Not applicable

Impact of a Novel Brain Longevity Supplement Containing the Postbiotic Urolithin A (Mitopure) on Cognitive Function and Related Health Outcomes

NCT07060898 · tracked via the Priya Life Science USA tracker
Sponsor
Amazentis SA
Phase
Not applicable
Started
2025-07-29
Last updated
2026-03-06

Condition(s) studied

AgingCognitive DeclineBrain FogCognitive Function

Investigational drug(s) / intervention(s)

Active ProductPlacebo Product

Active Product: Novel Nutritional Product targeting Cognition

Placebo Product: Identical placebo product

Study summary

This is a parallel group, randomized, double-blind, placebo-controlled clinical study assessing the safety and effects of a novel nutritional product on self-reported cognitive function and health in adults that reside in the USA. Participants will take their assigned study product (active or placebo) for 8 weeks and answer validated electronic surveys assessing cognitive function delivered to them through a text message (SMS) link or through email.

Eligibility

Sex
ALL
Min age
40 Years
Max age
Healthy volunteers
Accepted
Inclusion Criteria: Participants must meet all the following 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: 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. 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Radicle Science, Inc Office Encinitas California

More Amazentis SA trials in the USA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07060898 on ClinicalTrials.gov ↗ ← All trials in the USA