Radicle Health1: A Study of Health and Wellness Formulations and Their Effects on Overall Health

Study Overview
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Brief Summary
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A randomized, blinded, placebo-controlled study of health and wellness product formulations and their effects on overall health

Detailed Description
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This is a randomized, 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 better health during screening; (2) indicate an interest in taking a health and wellness product to potentially help improve their health, 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 will be collected electronically from eligible participants over 5 weeks. Participant reports of health indicators will be collected during 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™ Health1: A Randomized, Blinded, Placebo-controlled Study of Health and Wellness Formulations and Their Effects on Overall Health

Conditions
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Sleep, Pain, Depression, Anxiety

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21 years of age and older Resides in the United States Endorses: a desire for better sleep and/or focus, less pain, less feelings of stress, depression, and/or anxiety, and/or more energy (less fatigue) Expresses a willingness to take a study product that may contain cannabinoids (or placebo) and not know the product identity until the end of the study Exclusion Criteria: Reports being pregnant, trying to become pregnant, or breastfeeding Unable to provide a valid physical 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) Reports current enrollment in a clinical trial The QOL score greater than 5 during enrollment Unable to read and understand English Lack of reliable daily access to the internet Reports taking any medication that warns against grapefruit consumption Reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection

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 arm
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Control 1 Capsules<br>Health Product Form 1 Capsules - control | Dietary Supplement: Placebo Control Form 1 Capsules<br>* Participants will use their Placebo Control Form 1 Capsules as directed for a period of 4 weeks.<br>|
| Experimental: Active Product 1.1 Capsules<br>Health Product Form 1 Capsules - active product 1 | Dietary Supplement: Health Active Study Product 1.1 Capsules<br>* Participants will use their Radicle Health Active Study Product 1.1 Capsules as directed for a period of 4 weeks.<br>|
| Experimental: Active Product 1.2 Capsules<br>Health Product Form 1 Capsules - active product 2 | Dietary Supplement: Health Active Study Product 1.2 Capsules<br>* Participants will use their Radicle Health Active Study Product 1.2 Capsules as directed for a period of 4 weeks.<br>|
| Experimental: Active Product 1.3 Capsules<br>Health Product Form 1 Capsules - active product 3 | Dietary Supplement: Health Active Study Product 1.3 Capsules<br>* Participants will use their Radicle Health Active Study Product 1.3 Capsules as directed for a period of 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in overall health-related quality of life | Mean difference in overall health score as assessed by Patient Reported Outcome Measurement System (PROMIS) 29+2 Profile (PROPr; scale 70-120; with higher scores corresponding to greater overall health across 7 health domains: physical function, ability to participate in social roles and activities, cognitive function, anxiety, depression, fatigue, sleep disturbance, pain interference and pain intensity) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical function | Mean difference in physical function score as assessed by PROMIS PROPr items related to physical function (scale 4-20; with higher scores corresponding to greater physical function) | 4 weeks | 
| Change in feelings of anxiety | Mean difference in feelings of anxiety score as assessed by PROMIS PROPr items related to anxiety (scale 4-20; with higher scores corresponding to more severe feelings of anxiety) | 4 weeks | 
| Change in feelings of depression | Mean difference in feelings of depression score as assessed by PROMIS PROPr items related to depression (scale 4-20; with higher scores corresponding to more severe feelings of depression) | 4 weeks | 
| Change in fatigue | Mean difference in fatigue score as assessed by PROMIS PROPr questions related to fatigue (scale 4-20; with higher scores corresponding to more severe fatigue) | 4 weeks | 
| Change in sleep disturbance | Mean difference in sleep disturbance score as assessed by PROMIS PROPr items related to sleep disturbance (scale 4-20; with higher scores corresponding to greater sleep disturbance) | 4 weeks | 
| Change in socialization ability | Mean difference in socialization ability score as assessed by PROMIS PROPr items related to (scale 4-20; with higher scores corresponding to greater ability to participate in social roles and activities) | 4 weeks | 
| Change in pain | Mean difference in pain score as assessed by PROMIS PROPr items related to pain (scale 1-15; with higher scores corresponding to greater pain) | 4 weeks | 
| Change in cognitive function | Mean difference in cognitive function score as assessed by PROMIS PROPr items related to cognitive function (scale 2-10; with higher scores corresponding to greater cognitive function) | 4 weeks | 
| Change in libido | Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; where higher scores correspond to greater interest in sexual activities) | 4 weeks | 
| Minimal clinical importance difference (MCID) in overall health-related quality of life | Likelihood of achieving a MCID in overall health-related quality of life, as measured by PROMIS PROPr (scale 70-120; with higher scores corresponding to greater overall health-related quality of life) | 4 weeks |