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

Radicle™ Health1: A Randomized, Blinded, Placebo-controlled Study of Health and Wellness Formulations and Their Effects on Overall Health

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

Study Overview

• Status: Completed
• Conditions: Depression; Pain; Sleep; Anxiety
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 1494
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Del Mar, California, United States, 92014
      • Radicle Science, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Radicle Science
• Investigators: Principal Investigator: Emily K. Pauli, PharmD, Radicle Science, Inc

Publications and helpful links

Helpful Links

• Radicle Science, Inc

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2023
• Primary Completion (Actual): June 9, 2023
• Study Completion (Actual): October 27, 2023

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: RADX-22D07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared with researchers outside of Radicle Collaborators on this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No