Suspended

Radicle Energy™ 24_RCA on Fatigue and Health Outcomes

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What is being tested

Energy Product Placebo Control

+ Energy Active Product 1
Dietary Supplement
Who is being recruted

Fatigue

Over 21 Years
+17 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Other Study

Placebo-Controlled
Interventional
Study Start: September 2025

See protocol details

Summary

Principal SponsorRadicle Science
Last updated: October 2, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 9, 2025Actual date on which the first participant was enrolled.

This study aims to explore how certain health and wellness products can affect fatigue and other related health outcomes in adults living in the United States. It is designed to see if these products can offer a meaningful improvement of at least 30% in the participants' primary health concerns. The study is important as it could provide insights into effective ways to manage fatigue, which is a common problem impacting many people's daily lives. To ensure accurate results, participants must agree to take a product, not knowing whether they are receiving an actual wellness product or a placebo until the study concludes. Participants in the study will provide self-reported health data electronically over a period of seven weeks, without needing to attend any in-person visits. Health indicators are assessed at the beginning and throughout the study, with a final survey at the end. The study is carefully designed to ensure safety, excluding individuals with certain health conditions, heavy drinkers, and those who are pregnant or breastfeeding. By collecting data electronically, the study aims to reflect real-world conditions and gather valuable evidence on the effectiveness of these wellness products in reducing fatigue.

Official TitleRadicle Energy™ 24_RCA: 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: October 2, 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.
Over 21 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
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)

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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
Placebo
Energy Product Control
Group II
Experimental
Energy Active Product 1
Study Objectives
Primary Objectives

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

Difference in rates of change over time in sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance)

Difference between rates of change over time in feelings of anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)

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.Del Mar, United StatesSee the location
SuspendedOne Study Center