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

Not Applicable

Completed

• Conditions: Energy
• Interventions: Dietary Supplement: Energy Study Product Usage

• Registration Number: NCT05502328
• Lead Sponsor: Radicle Science

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-12
• Study First Posted: 2022-08-16
• Study Start: 2022-08-17
• Primary Completion: 2022-12-31
• Study Completion: 2023-05-24
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1427

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control 1	Energy Study Product Usage	Energy Product Form 1 - control
Energy Product 1.1	Energy Study Product Usage	Energy Product Form 1 - active product 1
Control 2	Energy Study Product Usage	Energy Product Form 2 - control
Energy Product 1.2	Energy Study Product Usage	Energy Product Form 1 - active product 2
Energy Product 2.1	Energy Study Product Usage	Energy Product Form 2 - active 1
Energy Product 2.2	Energy Study Product Usage	Energy Product Form 2 - active 2

Primary Outcome Measures

Name	Time	Method
Change in energy	4 weeks	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)
Change in focus	4 weeks	Change in concentration (ability to focus) score as assessed by PROMIS™ Cognition 6a (scale 1-5; where lower score is worse focus (cognitive function))

Secondary Outcome Measures

Name	Time	Method
Change in body weight	4 weeks	Change in body weight as assessed by self-reported body weight in pounds
Change in overall quality of life (QOL)	4 weeks	Change in QOL score as assessed by Kemp QOL (scale 1-7; with higher scores corresponding to higher quality of life)
Change in appetite	4 weeks	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')
Change in energy (measure 2)	4 weeks	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')
Change in overall well-being	4 weeks	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)

Trial Locations

Locations (1)

Radicle Science, Inc; 🇺🇸 Del Mar, California, United States