Radicle Energy: A Study of Cannabinoids on Energy and Other Health Outcomes

Study Overview
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Brief Summary
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A randomized, blinded, placebo-controlled study of cannabinoid formulations and their effects on energy levels, focus, appetite and other health outcomes

Detailed Description
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This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult participants per study arm (3000 total), age 21 and older and residing in the United States. Eligible participants will (1) endorse a desire for more energy (less fatigue and/or better concentration/focus during screening); (2) indicate a willingness to refrain from taking cannabinoids during the study period, and (3) indicate an interest in taking a plant derived cannabinoid product to help with their energy and/or focus. Participants with known liver disease, heavy drinkers, and those who are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking medications that warn against grapefruit consumption will be excluded. People with a calculated BMI of 18.5 or less will be excluded. Self-reported data are 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™ Energy: A Randomized, Blinded, Placebo-controlled Study of Cannabinoid Formulations and Their Effects on Energy Levels, Focus, Appetite and Other Health Outcomes

Conditions
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Energy

Intervention / Treatment
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* Dietary Supplement: Energy Study Product Usage


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 more energy (less fatigue) and/or a desire for better concentration (focus/attention) Selects more energy and/or better concentration as a primary reason for taking a cannabinoid product Expresses a willingness to refrain from taking any non-study cannabinoid product (i.e. CBD, THC) for the duration of participant engagement Expresses a willingness to take a study product and not knowing the product identity until the end of the study Exclusion Criteria: Pregnant, trying to become pregnant, or breastfeeding Reports a diagnosis of liver disease Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) Unable to read and understand English Lack of reliable daily access to the internet Reports taking any medication that warns against grapefruit consumption Calculated BMI 18.5 or less

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 and endorsement of problems with energy and/or focus reported during enrollment, then randomized to one of the study arms
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control 1<br>Energy Product Form 1 - control | Dietary Supplement: Energy Study Product Usage<br>* Participants will use their Radicle Energy study product as directed for a period of 4 weeks.<br>|
| Placebo Comparator: Control 2<br>Energy Product Form 2 - control | Dietary Supplement: Energy Study Product Usage<br>* Participants will use their Radicle Energy study product as directed for a period of 4 weeks.<br>|
| Experimental: Energy Product 1.1<br>Energy Product Form 1 - active product 1 | Dietary Supplement: Energy Study Product Usage<br>* Participants will use their Radicle Energy study product as directed for a period of 4 weeks.<br>|
| Experimental: Energy Product 1.2<br>Energy Product Form 1 - active product 2 | Dietary Supplement: Energy Study Product Usage<br>* Participants will use their Radicle Energy study product as directed for a period of 4 weeks.<br>|
| Experimental: Energy Product 2.1<br>Energy Product Form 2 - active 1 | Dietary Supplement: Energy Study Product Usage<br>* Participants will use their Radicle Energy study product as directed for a period of 4 weeks.<br>|
| Experimental: Energy Product 2.2<br>Energy Product Form 2 - active 2 | Dietary Supplement: Energy Study Product Usage<br>* Participants will use their Radicle Energy study product 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 energy | Change in mean energy score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 7a (scale 1-5; where lower score is less fatigue) | 4 weeks | 
| Change in focus | Change in concentration (ability to focus) score as assessed by PROMIS™ Cognition 6a (scale 1-5; where lower score is worse focus (cognitive function)) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in energy (measure 2) | Change in energy level score as assessed by a visual analog scale (VAS; Scoring from 0 to 10, with 0 being 'No energy' and 10 being 'More than enough energy') | 4 weeks | 
| Change in body weight | Change in body weight as assessed by self-reported body weight in pounds | 4 weeks | 
| Change in appetite | Change in appetite as assessed by a visual appetite scale (VAS; Scoring from 0 to 10, with 0 being 'No hunger' and 10 being 'Always hungry') | 4 weeks | 
| Change in overall quality of life (QOL) | Change in QOL score as assessed by Kemp QOL (scale 1-7; with higher scores corresponding to higher quality of life) | 4 weeks | 
| Change in overall well-being | Change in well-being score as assessed by World Health Organization 5 Well-being Index (WHO-5 Well-being Index; with higher scores corresponding to greater well-being) | 4 weeks |