Radicle Energy™ 24_RCA: A Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes

NCT07166523 | Completed

• 1 other identifier: RADX_P_2404_RCA
• Study Type: interventional
• Target: 501
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blind, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on fatigue and related health outcomes

Conditions

Fatigue

Outcome Measures

Primary Outcomes (1)

• Change in Fatigue

  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)

  7 weeks

Secondary Outcomes (3)

• Change in Cognitive Function

  7 weeks

• Change in Sleep

  7 weeks

• Change in Feelings of Anxiety

  7 weeks

Other Outcomes (4)

• Minimal clinical importance difference (MCID) in Fatigue

  7 weeks

• Minimal clinically important difference (MCID) in Cognitive Function

  7 weeks

• Minimal clinically important difference (MCID) in Sleep

  7 weeks

Study Arms (2)

Placebo Control

PLACEBO COMPARATOR

Energy Product Control

Dietary Supplement: Energy Product Placebo Control

Active Product 1

EXPERIMENTAL

Energy Active Product 1

Dietary Supplement: Energy Active Product 1

Interventions

Energy Product Placebo Control DIETARY_SUPPLEMENT

Participants will use their Energy Product Placebo Control as directed for a period of 6 weeks

Placebo Control

Energy Active Product 1 DIETARY_SUPPLEMENT

Participants will use their Energy Active Product 1 as directed for a period of 6 weeks

Active Product 1

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science Inc.

Del Mar, California, 92014, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Susan Hewlings

  Radicle Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be stratified based on their assigned sex at birth and health outcome score during enrollment, then randomized to one of the study arms. Each participant will have an equal chance of being assigned to any study arm.

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 10, 2025
• Study Start: September 9, 2025
• Primary Completion: November 26, 2025
• Study Completion: November 26, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)