Completed

Health and Wellness Products on Cognitive Function in Adults

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What is being tested

Clarity Placebo Control

+ Clarity Active Product
Dietary Supplement
Who is being recruted

Cognitive Function

From 21 to 105 Years
+17 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Other Study

Placebo-Controlled
Interventional
Study Start: June 2025

See protocol details

Summary

Principal SponsorRadicle Science
Last updated: November 3, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: June 26, 2025Actual date on which the first participant was enrolled.

This study looks at how health and wellness products might improve brain function and overall health in adults living in the United States. It aims to see if these products can lead to a meaningful improvement in certain health outcomes, specifically aiming for at least a 30% improvement. The study is important because it could offer new insights into how these products can be used to enhance cognitive health and address some unmet needs in this area. People with certain medical conditions, like heart, liver, or kidney issues, or those who are pregnant or heavy drinkers, are not eligible to participate. Participants in this study will take the product without knowing its exact ingredients until the study finishes, ensuring unbiased results. They will provide data about their health electronically over seven weeks, with assessments taken before starting, during, and at the end of the study. There are no in-person visits required, making it convenient for participants. The study will measure the changes in health indicators reported by participants to determine the effectiveness of the products. This design helps researchers gather real-world evidence on the potential benefits of these wellness products.

Official TitleRadicle ClarityTM 25_SR.1: 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 
Principal SponsorRadicle Science
Last updated: November 3, 2025
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
500 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Other Study
Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 21 to 105 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Cognitive Function
Criteria
5 inclusion criteria required to participate
Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
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

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12 exclusion criteria prevent from participating
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)

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
Placebo
Clarity product control
Group II
Experimental
Clarity active product
Study Objectives
Primary Objectives

Difference between rates of change over time in Cognitive Function score as assessed by PROMIS Cognitive Function 8a (scale 8-40; where the higher scores correspond to better cognitive function)
Secondary Objectives

Difference between rates of change over time in fatigue score as assessed by PROMIS Fatigue 4a (scale 4-20; where the higher scores correspond to worse fatigue)

Difference between rates of change over time in sleep score as assessed by PROMIS Sleep-Related Impairment 4a (scale 4-20; where the higher scores correspond to worse sleep)

Difference between rates of change over time in Cognitive Abilities score as assessed by PROMIS Cognitive Function - Abilities 8a (scale 8-40; where the higher scores correspond to better cognitive abilities)

Likelihood of achieving a MCID in cognitive function, as measured by PROMIS Cognitive Function 8a (scale 8-40; where the higher scores correspond to better cognitive function)

Likelihood of achieving a MCID in cognitive abilities, as measured by PROMIS Cognitive Function - Abilities 8a (scale 8-40; where the higher scores correspond to better cognitive abilities)

Likelihood of achieving a MCID in fatigue, as measured by PROMIS Fatigue 4a (scale 4-20; where the higher scores correspond to worse fatigue)

Likelihood of achieving a MCID in sleep, as measured by PROMIS Sleep-Related Impairment 4a (scale 4-20; where the higher scores correspond to worse sleep)

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 ScienceDel Mar, United StatesSee the location
CompletedOne Study Center