Radicle Health1: A Study of Health and Wellness Formulations and Their Effects on Overall Health
- Conditions
- AnxietyDepressionPainSleep
- Interventions
- Dietary Supplement: Placebo Control Form 1 CapsulesDietary Supplement: Health Active Study Product 1.1 CapsulesDietary Supplement: Health Active Study Product 1.2 CapsulesDietary Supplement: Health Active Study Product 1.3 Capsules
- Registration Number
- NCT05783232
- Lead Sponsor
- Radicle Science
- Brief Summary
A randomized, blinded, placebo-controlled study of health and wellness product formulations and their effects on overall health
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1494
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Control 1 Capsules Placebo Control Form 1 Capsules Health Product Form 1 Capsules - control Active Product 1.1 Capsules Health Active Study Product 1.1 Capsules Health Product Form 1 Capsules - active product 1 Active Product 1.2 Capsules Health Active Study Product 1.2 Capsules Health Product Form 1 Capsules - active product 2 Active Product 1.3 Capsules Health Active Study Product 1.3 Capsules Health Product Form 1 Capsules - active product 3
- Primary Outcome Measures
Name Time Method Change in overall health-related quality of life 4 weeks 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)
- Secondary Outcome Measures
Name Time Method Change in feelings of depression 4 weeks 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)
Change in fatigue 4 weeks 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)
Change in physical function 4 weeks 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)
Change in feelings of anxiety 4 weeks 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)
Change in sleep disturbance 4 weeks 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)
Change in pain 4 weeks Mean difference in pain score as assessed by PROMIS PROPr items related to pain (scale 1-15; with higher scores corresponding to greater pain)
Change in socialization ability 4 weeks 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)
Minimal clinical importance difference (MCID) in overall health-related quality of life 4 weeks 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)
Change in cognitive function 4 weeks 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)
Change in libido 4 weeks 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)
Trial Locations
- Locations (1)
Radicle Science, Inc
🇺🇸Del Mar, California, United States