Radicle Energy2: A Study of Health and Wellness Products on Fatigue and Other Health Outcomes

Study Overview
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Brief Summary
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A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on fatigue and other health outcomes

Detailed Description
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This is a parallel group, randomized, double-blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States. Eligible participants will (1) endorse a desire for more energy, (2) have the opportunity for meaningful improvement in their health outcome score, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study. Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded. Self-reported data are collected electronically from eligible participants over 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.

Official Title
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Radicle™ Energy2: A Parallel Group, Randomized, Double-Blinded, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Fatigue and Other Health Outcomes

Conditions
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Fatigue, Energy

Intervention / Treatment
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* Dietary Supplement: Energy Placebo Control Form 1
* Dietary Supplement: Energy Active Study Product 1.1 Usage
* Dietary Supplement: Energy Active Study Product 1.2 Usage
* Dietary Supplement: Energy Active Study Product 1.3 Usage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults, 21 years of age and older 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 as a primary desire Has the opportunity for at least 20% improvement in their primary health outcome score 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 Unable to provide a valid US shipping address and mobile phone number Reports a diagnosis of liver or kidney disease Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) Unable to read and understand English Reports current enrollment in another clinical trial Lack of reliable daily access to the internet Reports current use of chemotherapy or immunotherapy Reports taking medications that have a well-established moderate or severe interaction, or pose a substantial safety risk with the active ingredients studied: Anticoagulants, antihypertensives, anti-anxiolytics, antidepressants, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs (monoamine oxidase inhibitors), or thyroid products Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: NYHA (New York Heart Association) Class III or IV congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 105 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be stratified based on gender at birth, then randomized to one of the study arms
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Control 1<br>Energy Product Form 1 - control | Dietary Supplement: Energy Placebo Control Form 1<br>* Participants will use their Radicle Energy Placebo Control Form 1 as directed for a period of 6 weeks.<br>|
| Experimental: Active Product 1.1<br>Energy Product Form 1 - active product 1 | Dietary Supplement: Energy Active Study Product 1.1 Usage<br>* Participants will use their Radicle Energy Active Study Product 1.1 as directed for a period of 6 weeks.<br>|
| Experimental: Active Product 1.2<br>Energy Product Form 1 - active product 2 | Dietary Supplement: Energy Active Study Product 1.2 Usage<br>* Participants will use their Radicle Energy Active Study Product 1.2 as directed for a period of 6 weeks.<br>|
| Experimental: Active Product 1.3<br>Energy Product Form 1 - active product 3 | Dietary Supplement: Energy Active Study Product 1.3 Usage<br>* Participants will use their Radicle Energy Active Study Product 1.3 as directed for a period of 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fatigue | Mean difference 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) | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in focus (cognitive function) | Mean difference in focus score as assessed by PROMIS Cognitive Function 4A (scale 4-20; where lower scores correspond to worse cognitive function) | 6 weeks | 
| Change in sleep | Mean difference in sleep score as assessed by PROMIS Sleep Disturbance 4A (scale 4 to 20; where higher scores correspond to higher levels of sleep disturbance) | 6 weeks | 
| Change in feelings of anxiety | Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; where higher scores correspond to greater levels of anxiety) | 6 weeks | 
| Minimal clinically important difference (MCID) in fatigue | Likelihood of experiencing MCID in fatigue score as assessed by PROMIS Fatigue 8A | 6 weeks | 
| Minimal clinically important difference (MCID) in focus (cognitive function) | Likelihood of experiencing MCID in focus score as assessed by PROMIS Cognitive Function 4A | 6 weeks | 
| Minimal clinically important difference (MCID) in sleep | Likelihood of experiencing MCID in sleep score as assessed by PROMIS Sleep Disturbance 4A | 6 weeks | 
| Minimal clinically important difference (MCID) in feelings of anxiety | Likelihood of experiencing MCID in anxiety score as assessed by PROMIS Anxiety 4A | 6 weeks |