Fatigue Clinical Trial
Official title:
Radicle Recharge™: A Randomized, Double-blind, Placebo-controlled Trial Assessing the Immediate Effects of Non-caffeinated Supplements on Energy Levels and Associated Health Outcomes
Verified date | May 2024 |
Source | Radicle Science |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A randomized, double blind, placebo-controlled trial assessing the immediate impact of non-caffeinated supplements on energy levels and associated health outcomes
Status | Completed |
Enrollment | 264 |
Est. completion date | April 30, 2024 |
Est. primary completion date | October 26, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 105 Years |
Eligibility | Inclusion Criteria: - Adults at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, sexes, and gender identities - Attending the Supply Side West meeting in person - Able to read and understand English - Endorses more energy as a primary desire - 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: - Reports being pregnant, trying to become pregnant, or breastfeeding - Reports current enrollment in another clinical trial - Reports a cardiac disease that presents an absolute contraindication and/or a significant safety concern with any of the study product ingredients. - Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study products ingredients: Anticoagulants, chemotherapy, immunotherapy, medications that warn against grapefruit consumption, oral diabetic medications, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection - Reports an allergy to any of the study products ingredients |
Country | Name | City | State |
---|---|---|---|
United States | Radicle Science, Inc | Del Mar | California |
Lead Sponsor | Collaborator |
---|---|
Radicle Science |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in energy | Mean difference in energy score as assessed by Energy Visual Analog Scale (VAS) (scale 0 - 10; where 0 is no energy and 10 is more than enough energy) | 5 hours | |
Secondary | Change in cognitive function | Mean difference in cognitive function score as assessed by Patient Reported Outcome Measurement System (PROMIS) Cognitive Function - Abilities 4A (scale 4-20; where lower scores correspond to worse cognitive function). Modified timing to, "since walking this morning" | 5 hours | |
Secondary | Change in fatigue | Mean difference in fatigue score as assessed by Fatigue VAS (scale 0 - 10; where 0 is no fatigue and 10 is completely exhausted) | 5 hours | |
Secondary | Minimal clinically important difference (MCID) in energy | Likelihood of experiencing MCID in energy score as assessed by Energy VAS | 5 hours | |
Secondary | Minimal clinically important difference (MCID) in cognitive function | Likelihood of experiencing MCID in cognitive function score as assessed by PROMIS Cognitive Function - Abilities 4A | 5 hours | |
Secondary | Minimal clinically important difference (MCID) in fatigue | Likelihood of experiencing MCID in fatigue score as assessed by Fatigue VAS | 5 hours |
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