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

Radicle Science1,000 enrolled

Overview

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

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 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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

1,000

Conditions

Fatigue

Interventions

Energy Placebo ControlDIETARY_SUPPLEMENT

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

Energy Active Product 1DIETARY_SUPPLEMENT

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

Energy Active Product 2DIETARY_SUPPLEMENT

Participants will use their Energy Active Product 2 as directed for a period of 6 weeks.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 105 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion 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: * 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

Locations (1)

Radicle Science, Inc

Del Mar, California, United States

Outcomes

Primary Outcomes

Change in fatigue

Difference between rates of change over time in Fatigue score as assessed by the PROMIS Fatigue 8a (scale 8-40; where the higher scores correspond to worse fatigue)

Time frame: 7 weeks

Secondary Outcomes

Change in cognitive function

Difference between rates of change over time in Cognitive Function score as assessed by the PROMIS Cognitive Function 4a (scale 4-20; where the higher scores correspond to better cognitive function)

Time frame: 7 weeks

Change in sleep disturbance

Difference between rates of change over time in Sleep disturbance score as assessed by the PROMIS Sleep Disturbance 4a (scale 4-20; where the higher scores correspond to worse sleep)

Time frame: 7 weeks

Change in mood

Difference between rates of change over time in Mood score as assessed by the PROMIS Depression 4a (scale 4-20; where the higher scores correspond to worse mood)

Time frame: 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 worse fatigue)

Time frame: 7 weeks

Minimal clinical importance difference (MCID) in cognitive function

Likelihood of achieving a MCID in cognitive function, as measured by PROMIS Cognitive Function 4a (scale 4-20; where the higher scores correspond to better cognitive function)

Time frame: 7 weeks

Minimal clinical importance difference (MCID) in sleep disturbance

Data from ClinicalTrials.gov

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