Radicle Energy 25: A Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes

Radicle 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

A Randomized, Double-Blind, Placebo Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes

Study Overview

• Status: Completed
• Conditions: Fatigue
• Intervention / Treatment: Dietary supplement: Energy Placebo Control; Dietary supplement: Energy Active Product

Detailed Description

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.

Eligible participants will (1) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (2) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.

Self-reported data are collected electronically from eligible participants for up to 7 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Del Mar, California, United States, 92014
      • Radicle Science, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants must meet all the following criteria:

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

Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

Exclusion Criteria:

• Individuals who report any of the following during screening will be excluded from participation:

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.

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

Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products

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 and/or pose a safety risk

Lack of reliable daily access to the internet

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active product; Energy Active Product	Dietary supplement: Energy Active Product; Participants will use their Energy Active Product as directed for a period of 6 weeks.
Placebo Comparator: Placebo control; Energy Product Control	Dietary supplement: Energy Placebo Control; Participants will use their Energy Placebo Control as directed for a period of 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fatigue	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)	7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cognitive Function	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)	7 weeks
Change in Sleep Disturbance	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)	7 weeks
Change in mood	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)	7 weeks
Minimal clinical importance difference (MCID) in fatigue	Likelihood of achieving a MCID in fatigue, as measured by PROMIS Fatigue 8A (scale 8-40; where the higher scores correspond to greater fatigue)	7 weeks
Minimal clinical importance difference (MCID) in cognitive function	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)	7 weeks
Minimal clinical importance difference (MCID) in sleep disturbance	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)	7 weeks
Minimal clinical importance difference (MCID) in mood	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)	7 weeks

Collaborators and Investigators

• Sponsor: Radicle Science
• Investigators: Principal Investigator: Susan Hewlings, Radicle Science Inc.

Publications and helpful links

Helpful Links

• Radicle Science, Inc

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2025
• Primary Completion (Actual): October 16, 2025
• Study Completion (Actual): October 16, 2025

Study Registration Dates

• First Submitted: June 16, 2025
• First Submitted That Met QC Criteria: June 16, 2025
• First Posted (Actual): June 25, 2025

Study Record Updates

• Last Update Posted (Estimated): November 3, 2025
• Last Update Submitted That Met QC Criteria: October 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Fatigue
• Other Study ID Numbers: RADX-P-2504_SR.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared with researchers outside of Radicle Collaborators on this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No