Radicle Rest 2: A Study of Health and Wellness Products on Sleep and Health Outcomes

Radicle™ Rest 2: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Sleep and Other Health Outcomes

A randomized, blinded, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on sleep and other health outcomes.

Study Overview

• Status: Active, not recruiting
• Conditions: Sleep Disorder; Sleep; Sleep Disturbance
• Intervention / Treatment: Dietary supplement: Placebo Control Form 1; Dietary supplement: Placebo Control Form 2; Dietary supplement: Placebo Control Form 3; Dietary supplement: Rest Study Active Product 1.1 Usage; Dietary supplement: Rest Study Active Product 1.2 Usage; Dietary supplement: Rest Study Active Product 2.1 Usage; Dietary supplement: Rest Study Active Product 2.2 Usage; Dietary supplement: Rest Study Active Product 3.1 Usage; Dietary supplement: Placebo Control Form 4; Dietary supplement: Rest Study Active Product 4.1 Usage; Dietary supplement: Rest Study Active Product 4.2 Usage; Dietary supplement: Rest Study Active Product 4.3 Usage

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 improved sleep, (2) indicate an interest in taking a health and wellness product to potentially help their sleep, 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 are collected electronically from eligible participants over 7 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 (Estimated): 4152
• 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:

• Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities
• Resides in the United States
• Endorses better sleep as a primary desire
• Selects sleep, looking to improve their sleep, and/or reduce reliance on medications as a reason for their interest in taking a health and wellness product
• Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

Exclusion Criteria:

• Reports being pregnant, trying to become pregnant, or breastfeeding
• Unable to provide a valid US shipping address
• The calculated validated health survey (PRO) measurement result is less than mild severity/impairment
• Reports a diagnosis of liver or kidney disease
• Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
• Unable to read and understand English
• Reports current enrollment in a clinical trial
• Lack of reliable daily access to the internet
• Reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection
• Reports taking medications with a known moderate or severe interaction with any of the active ingredients studied: anticoagulants, a medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, or monoamine oxidase inhibitors (MAOIs)
• Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: New York Heart Association (NYHA) Class III or IV congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias

Study Plan

How is the study designed?

Design Details

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

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Control 1; Rest Product Form 1 - control	Dietary supplement: Placebo Control Form 1; Participants will use Placebo Control Form 1 as directed for a period of 6 weeks.
Placebo Comparator: Placebo Control 2; Rest Product Form 2 - control	Dietary supplement: Placebo Control Form 2; Participants will use Placebo Control Form 2 as directed for a period of 6 weeks.
Placebo Comparator: Placebo Control 3; Rest Product Form 3 - control	Dietary supplement: Placebo Control Form 3; Participants will use Placebo Control Form 3 as directed for a period of 6 weeks.
Experimental: Active Product 1.1; Rest Product Form 1 - active product 1	Dietary supplement: Rest Study Active Product 1.1 Usage; Participants will use Radicle Rest Active Product 1.1 as directed for a period of 6 weeks.
Experimental: Active Product 1.2; Rest Product Form 1 - active product 2	Dietary supplement: Rest Study Active Product 1.2 Usage; Participants will use Radicle Rest Active Product 1.2 as directed for a period of 6 weeks.
Experimental: Active Product 2.1; Rest Product Form 2 - active product 1	Dietary supplement: Rest Study Active Product 2.1 Usage; Participants will use Radicle Rest Active Product 2.1 as directed for a period of 6 weeks.
Experimental: Active Product 2.2; Rest Product Form 2 - active product 2	Dietary supplement: Rest Study Active Product 2.2 Usage; Participants will use Radicle Rest Active Product 2.2 as directed for a period of 6 weeks.
Experimental: Active Product 3.1; Rest Product Form 3 - active product 1	Dietary supplement: Rest Study Active Product 3.1 Usage; Participants will use Radicle Rest Active Product 3.1 as directed for a period of 6 weeks.
Placebo Comparator: Placebo Control 4; Rest Product Form 4 - control	Dietary supplement: Placebo Control Form 4; Participants will use Placebo Control Form 4 as directed for a period of 6 weeks.
Experimental: Active Product 4.1; Rest Product Form 4 - active product 1	Dietary supplement: Rest Study Active Product 4.1 Usage; Participants will use Radicle Rest Active Product 4.1 as directed for a period of 6 weeks.
Experimental: Active Product 4.2; Rest Product Form 4 - active product 2	Dietary supplement: Rest Study Active Product 4.2 Usage; Participants will use Radicle Rest Active Product 4.2 as directed for a period of 6 weeks.
Experimental: Active Product 4.3; Rest Product Form 4 - active product 3	Dietary supplement: Rest Study Active Product 4.3 Usage; Participants will use Radicle Rest Active Product 4.3 as directed for a period of 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sleep disturbance	Mean difference in sleep disturbance score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance Short Form 8A (scale 8-40; where higher scores correspond to greater sleep disturbance)	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in anxiety	Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)	6 weeks
Change in mood (emotional distress)	Mean difference in mood score as assessed by PROMIS Depression 4A (scale 4-20; where higher scores correspond to more severe depression)	6 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 sexual interest)	6 weeks
Change in fatigue	Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; where higher scores correspond to more severe fatigue)	6 weeks
Change in cognitive function	Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 4A (scale 4-20; where higher scores correspond to greater cognitive function)	6 weeks
Minimal clinical importance difference (MCID) in sleep disturbance	Likelihood of achieving a MCID in sleep disturbance, as measured by PROMIS Sleep Disturbance Short Form 8A (scale 8-40; where higher scores correspond to greater sleep disturbance)	6 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): January 9, 2023
• Primary Completion (Actual): December 4, 2023
• Study Completion (Estimated): April 15, 2024

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 20, 2022

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 31, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: RADX-2301

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