Status:
COMPLETED
Radicle Energy 24: A Study of Health and Wellness Products on Fatigue and Related Health Outcomes
Lead Sponsor:
Radicle Science
Conditions:
Fatigue
Energy
Eligibility:
All Genders
21-105 years
Phase:
NA
Brief Summary
A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on fatigue and related health outcomes
Detailed Description
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants will (1) endorse a desire for more energy/less fat...
Eligibility Criteria
Inclusion
- 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
- Endorses more energy/less fatigue as a primary desire
- Has the opportunity for at least 20% 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
- 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 (New York Heart Association) Class Ill 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, MAOls (monoamine oxidase inhibitors), or thyroid products
- Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s)
- Lack of reliable daily access to the internet
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2025
Estimated Enrollment :
5543 Patients enrolled
Trial Details
Trial ID
NCT06201689
Start Date
February 1 2024
End Date
July 10 2025
Last Update
July 14 2025
Active Locations (1)
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1
Radicle Science, Inc
Del Mar, California, United States, 92014