An interventional study of Energy Study Product Usage in Energy, sponsored by Radicle Science. Completed at 1 site in United States. Open to participants aged 21 Years to 105 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Radicle Science · Not applicable, Interventional, and Other
A randomized, blinded, placebo-controlled study of cannabinoid formulations and their effects on energy levels, focus, appetite and other health outcomes
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.
Radicle Science is the lead sponsor of 64 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
CBD, THC) for the duration of participant engagement
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
Energy Product Form 1 - control
Dietary Supplement: Energy Study Product Usage
Energy Product Form 2 - control
Dietary Supplement: Energy Study Product Usage
Energy Product Form 1 - active product 1
Dietary Supplement: Energy Study Product Usage
Energy Product Form 1 - active product 2
Dietary Supplement: Energy Study Product Usage
Energy Product Form 2 - active 1
Dietary Supplement: Energy Study Product Usage
Energy Product Form 2 - active 2
Dietary Supplement: Energy Study Product Usage
Participants will use their Radicle Energy study product as directed for a period of 4 weeks.
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)
Time frame: 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))
Time frame: 4 weeks
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')
Time frame: 4 weeks
Change in body weight
Change in body weight as assessed by self-reported body weight in pounds
Time frame: 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')
Time frame: 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)
Time frame: 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)
Time frame: 4 weeks
Change in pain
Change in pain score as assessed by the Pain on average, Enjoyment of life, and General activity Score (PEG; scale 0-10 where 0 is no pain)
Time frame: 4 weeks
Change in Sleep quality
Change in sleep quality (sleep disturbance) score as assessed by the PROMIS Sleep Disturbance 4A (scale 4 to 20; where higher scores correspond to higher levels of sleep disturbance)
Time frame: 4 weeks
Change in feelings of anxiety
Change in anxiety score as assessed by the PROMIS Anxiety 4a (scale 4-20; where higher scores correspond to greater levels of anxiety)
Time frame: 4 weeks
Change in Stress
Change in stress score as assessed by the PROMIS Stress 4a (scale 4-20; where higher scores correspond to greater levels of stress)
Time frame: 4 weeks
Plan to share: No — Data will not be shared with researchers outside of Radicle Collaborators on this study.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Radicle Science