COMPLETED

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

Conditions

Aging Cognitive Decline Brain Fog Cognitive Function mitochondria brain cognition

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Radicle Clarity™ 25_RAM: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Cognitive Function and Related Health Outcomes

Quick Facts

Study Start:2025-07-29

Study Completion:2025-11-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT07060898

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Adults, at least 40 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities * 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	* 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. * Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients. * 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

Inclusion Criteria

Exclusion Criteria

* Adults, at least 40 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
* 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

* 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.
* Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.
* 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

Contacts and Locations

Principal Investigator

Susan Hewlings, PhD

PRINCIPAL_INVESTIGATOR

Radicle Science Inc.

Study Locations (Sites)

Radicle Science, Inc Office

Encinitas, California, 92024

United States

Collaborators and Investigators

Sponsor: Amazentis SA

Susan Hewlings, PhD, PRINCIPAL_INVESTIGATOR, Radicle Science Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-29

Study Completion Date2025-11-20

Study Record Updates

Study Start Date2025-07-29

Study Completion Date2025-11-20

Terms related to this study

Keywords Provided by Researchers

mitochondria
brain
cognition
aging

Additional Relevant MeSH Terms

Aging
Cognitive Decline
Brain Fog
Cognitive Function