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

Not Applicable

Completed

• Conditions: Sleep; Sleep Disorder; Sleep Disturbance
• Interventions: Dietary Supplement: Rest Study Active Product 1.1 Usage; Dietary Supplement: Rest Study Active Product 2.1 Usage; Dietary Supplement: Rest Study Active Product 4.2 Usage; Dietary Supplement: Placebo Control Form 1; 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: Placebo Control Form 3; Dietary Supplement: Placebo Control Form 2; Dietary Supplement: Rest Study Active Product 1.2 Usage; Dietary Supplement: Rest Study Active Product 4.3 Usage; Dietary Supplement: Rest Study Active Product 4.1 Usage

• Registration Number: NCT05657808
• Lead Sponsor: Radicle Science

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2022-12-12
• Study First Posted: 2022-12-20
• Study Start: 2023-01-09
• Primary Completion: 2023-12-04
• Study Completion: 2024-04-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4152

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Product 1.1	Rest Study Active Product 1.1 Usage	Rest Product Form 1 - active product 1
Active Product 2.1	Rest Study Active Product 2.1 Usage	Rest Product Form 2 - active product 1
Active Product 4.2	Rest Study Active Product 4.2 Usage	Rest Product Form 4 - active product 2
Placebo Control 1	Placebo Control Form 1	Rest Product Form 1 - control
Active Product 2.2	Rest Study Active Product 2.2 Usage	Rest Product Form 2 - active product 2
Active Product 3.1	Rest Study Active Product 3.1 Usage	Rest Product Form 3 - active product 1
Placebo Control 4	Placebo Control Form 4	Rest Product Form 4 - control
Placebo Control 3	Placebo Control Form 3	Rest Product Form 3 - control
Placebo Control 2	Placebo Control Form 2	Rest Product Form 2 - control
Active Product 1.2	Rest Study Active Product 1.2 Usage	Rest Product Form 1 - active product 2
Active Product 4.3	Rest Study Active Product 4.3 Usage	Rest Product Form 4 - active product 3
Active Product 4.1	Rest Study Active Product 4.1 Usage	Rest Product Form 4 - active product 1

Primary Outcome Measures

Name	Time	Method
Change in sleep disturbance	6 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Change in anxiety	6 weeks	Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)
Change in fatigue	6 weeks	Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; where higher scores correspond to more severe fatigue)
Change in cognitive function	6 weeks	Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 4A (scale 4-20; where higher scores correspond to greater cognitive function)
Change in mood (emotional distress)	6 weeks	Mean difference in mood score as assessed by PROMIS Depression 4A (scale 4-20; where higher scores correspond to more severe depression)
Change in libido	6 weeks	Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; where higher scores correspond to greater sexual interest)
Minimal clinical importance difference (MCID) in sleep disturbance	6 weeks	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)

Trial Locations

Locations (1)

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