Completed

CLARITYStudy of Health and Wellness Products' Impact on Cognitive Function

Study Aim

This study explores how health and wellness products affect cognitive function in adults, using the validated PROMIS™ Cognitive Function 8A assessment scale.

What is being tested

Active Product

+ Placebo Product

Dietary Supplement

Who is being recruted

Behavior+7

+ Mental Disorders

+ Behavioral Symptoms

Over 40 Years

+14 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Placebo-Controlled

Interventional

Study Start: July 2025

See protocol details

Summary

Principal SponsorAmazentis SA

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 29, 2025

Actual date on which the first participant was enrolled.

This clinical study focuses on understanding how a new nutritional product may influence cognitive function and overall health in adults living in the USA. The study aims to determine if this product can improve self-reported mental capabilities, such as memory and problem-solving skills, compared to a placebo. This is important because it could offer a new way for people to enhance their cognitive health and potentially improve daily functioning without relying on pharmaceuticals. Participants are randomly assigned to receive either the actual product or a placebo for a duration of 8 weeks. During this time, they will regularly complete electronic surveys about their cognitive abilities, which are accessed via SMS links or email. These surveys are designed to evaluate any changes in mental function, providing data on the product's effectiveness. The study is conducted in a way that neither the participants nor the researchers know who receives the actual product, minimizing bias and ensuring reliable results.

Official TitleRadicle 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

NCT07060898

Principal SponsorAmazentis SA

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

650 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersBehavioral SymptomsCognition DisordersFatigueMental FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersCognitive Dysfunction

Criteria

4 inclusion criteria required to participate

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

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

Resides in the United States

10 exclusion criteria prevent from participating

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 current enrollment in another clinical trial

Unable to provide a valid US shipping address and mobile phone number

Lack of reliable daily access to the internet

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

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

Group II

Placebo

Identical Placebo product

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Radicle Science, Inc Office

Encinitas, United StatesOpen Radicle Science, Inc Office in Google Maps

CompletedOne Study Center