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

Not Applicable

Active, not recruiting

• Conditions: Aging; Cognitive Decline; Brain Fog; Cognitive Function

• Registration Number: NCT07060898
• Lead Sponsor: Amazentis SA

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-02
• Study First Submitted QC: 2025-07-02
• Study First Posted: 2025-07-11
• Study Start: 2025-07-29
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-02
• Last Update Posted: 2025-09-08
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 650

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cognitive function	8 weeks	Change in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; where higher scores correspond to better cognitive function)

Secondary Outcome Measures

Name	Time	Method
Fatigue	8 weeks	Change in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 4A (scale 4-20; where higher scores correspond to worse fatigue)
Sleep-related impairment	8 weeks	Change in sleep score as assessed by PROMIS Sleep-Related Impairment 4a (scale 4-20; where the higher scores correspond to worse sleep)
Cognitive abilities	8 weeks	Change in Cognitive Abilities score as assessed by PROMIS Cognitive Function - Abilities 8a (scale 8-40; where the higher scores correspond to better cognitive abilities)
Cognitive function (brain health) via smartphone application assessments	8 weeks	Change in cognitive function evaluated with DANA Brain Vital app
Minimal clinically important difference (MCID) in cognitive function	8 weeks	Likelihood of achieving minimal clinically important difference in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; where higher scores correspond to better cognitive function)
Minimal clinically important difference (MCID) in fatigue	8 weeks	Likelihood of achieving minimal clinically important difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; where higher scores correspond to worse fatigue)
Minimal clinically important difference (MCID) in sleep	8 weeks	Likelihood of achieving minimal clinically important difference in sleep score, as measured by PROMIS Sleep-Related Impairment 4a (scale 4-20; where the higher scores correspond to worse sleep)
Minimal clinically important difference (MCID) in cognitive abilities	8 weeks	Likelihood of achieving minimal clinically important difference in cognitive abilities score as assessed by PROMIS Cognitive Function - Abilities 8a (scale 8-40; where the higher scores correspond to better cognitive abilities)
Adverse Events	8 weeks

Trial Locations

Locations (1)

Radicle Science, Inc Office; 🇺🇸 Encinitas, California, United States