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

NCT07060898 | Active Not Recruiting

• 1 other identifier: RADX-SP-2506_RAM
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Brain Fog; Cognitive Function; Cognitive Decline

Keywords

mitochondria; brain; cognition; aging

Outcome Measures

Primary Outcomes (1)

• Cognitive function

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

  8 weeks

Secondary Outcomes (9)

• Fatigue

  8 weeks

• Sleep-related impairment

  8 weeks

• Cognitive abilities

  8 weeks

• Cognitive function (brain health) via smartphone application assessments

  8 weeks

• Minimal clinically important difference (MCID) in cognitive function

  8 weeks

Study Arms (2)

Active

ACTIVE COMPARATOR

Novel nutritional product (containing Mitopure Urolithin A) targeting improvements in cognitive health

Dietary Supplement: Active Product

Placebo

PLACEBO COMPARATOR

Identical Placebo product

Dietary Supplement: Placebo Product

Interventions

Active Product DIETARY_SUPPLEMENT

Novel Nutritional Product targeting Cognition

Active

Placebo Product DIETARY_SUPPLEMENT

Identical placebo product

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amazentis SA: lead
• Radicle Science (sponsor): collaborator

Study Sites (1)

Radicle Science, Inc Office

Encinitas, California, 92024, United States

Location

Related Links

• Radicle Science, Inc

MeSH Terms

Conditions

Cognitive Dysfunction; Mental Fatigue

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Susan Hewlings, PhD

  Radicle Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: July 29, 2025
• Primary Completion: November 20, 2025
• Study Completion (Estimated): November 20, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)