Completed

Study of Health and Wellness Products' Impact on Fatigue

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study AimThis study will examine how health and wellness products may affect fatigue. We'll measure changes in your fatigue level using the Patient Reported Outcome Measurement System (PROMIS) Fatigue 8A score.
What is being tested

Energy Active Product

+ Energy Placebo Control
Dietary Supplement
Who is being recruted

Fatigue

From 21 to 105 Years
+19 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Other Study

Placebo-Controlled
Interventional
Study Start: July 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: July 22, 2025Actual date on which the first participant was enrolled.

This study is focused on assessing the effectiveness of health and wellness products in reducing fatigue and improving related health outcomes. It targets adults living in the United States who are looking for a significant improvement in their health, specifically at least a 30% enhancement in their primary health outcome. The study is important as it aims to provide insights into how these products might help people feel less tired and improve their overall health. Individuals with certain health conditions, such as heart, liver, or kidney diseases, or those with safety concerns related to certain medications, are not eligible to participate. This ensures a safe and focused investigation into the products' effects. Participants will be randomly assigned to receive either the wellness product or a placebo, and neither the participants nor the researchers will know which one each participant is taking until the end of the study. All data is self-reported and collected electronically over a period of up to seven weeks, meaning participants can participate from the comfort of their own homes without needing to visit a clinic. The study collects information at the beginning, during product use, and at the end to evaluate changes in health indicators related to fatigue. This approach helps in understanding the real-world impact of these wellness products.

Official TitleRadicle Energy™ 25_SR.1: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Fatigue 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
Fatigue
Criteria
6 inclusion criteria required to participate
Participants must meet all the following criteria
dults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
ssigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed
esides in the United States

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13 exclusion criteria prevent from participating
Individuals who report any of the following during screening will be excluded from participation
eport being pregnant, trying to become pregnant, or breastfeeding
nable to provide a valid US shipping address and mobile phone number
eports current enrollment in another clinical trial

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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
Experimental
Energy Active Product
Group II
Placebo
Energy Product Control
Study Objectives
Primary Objectives

Difference between rates of change over time in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 8A (scale 8-40; where the higher scores correspond to more fatigue)
Secondary Objectives

Difference between rates of change over time in cognitive function score as assessed by Patient Reported Outcome Measurement System (PROMIS) Cognitive Function 4A (scale 4-20; where the higher scores correspond to greater cognitive function)

Difference between rates of change over time in sleep disturbance score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance 4A (scale 4-20; where the higher scores correspond to more sleep disturbance)

Difference between rates of change over time in mood score as assessed by Patient Reported Outcome Measurement System (PROMIS) Depression 4A (scale 4-20; where the higher scores correspond to more feelings of depression)

Likelihood of achieving a MCID in fatigue, as measured by PROMIS Fatigue 8A (scale 8-40; where the higher scores correspond to greater fatigue)

Likelihood of achieving a MCID in cognitive function, as measured by PROMIS Cognitive Function Short Form 4A (scale 4-20; where the higher scores correspond to greater cognitive function)

Likelihood of achieving a MCID in sleep disturbance, as measured by PROMIS Sleep Disturbance 4A (scale 4-20; where the higher scores correspond to greater sleep disturbance)

Likelihood of achieving a MCID in mood, as measured by PROMIS Depression 4A (scale 4-20; where the higher scores correspond to greater feelings of depression)

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, IncDel Mar, United StatesSee the location
CompletedOne Study Center