Radicle Rest 24: A Study of Health and Wellness Products on Sleep and Related Health Outcomes

NCT06347744 | Completed

• 1 other identifier: RADX-P-2401
• Study Type: interventional
• Target: 1,646
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on sleep and related health outcomes.

Conditions

Sleep; Sleep Disturbance; Sleep Disorder

Outcome Measures

Primary Outcomes (1)

• Change in sleep

  Mean difference in sleep 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 Outcomes (7)

• Change in feelings of anxiety

  6 weeks

• Change in fatigue

  6 weeks

• Change in mood (emotional distress-depression)

  6 weeks

• Minimal clinically important difference (MCID) in sleep

  6 weeks

• Minimal clinically important difference (MCID) in feelings of anxiety

  6 weeks

Study Arms (6)

Placebo Control 1

PLACEBO COMPARATOR

Rest Product Form 1 - control

Dietary Supplement: Radicle Rest Placebo Control Form 1

Active Product 1.1

EXPERIMENTAL

Rest Product Form 1 - active product 1

Dietary Supplement: Radicle Rest Active Study Product 1.1 Usage

Placebo Control 2

PLACEBO COMPARATOR

Rest Product Form 2 - control

Dietary Supplement: Radicle Rest Placebo Control Form 2

Active Product 2.1

EXPERIMENTAL

Rest Product Form 2 - active product 1

Dietary Supplement: Radicle Rest Active Study Product 2.1 Usage

Placebo Control 4.1.0

EXPERIMENTAL

Rest Product 4 - control

Dietary Supplement: Radicle Rest Placebo Control 4.1.0

Active Product 4.1.1

EXPERIMENTAL

Rest Product 4 - active product 1

Dietary Supplement: Radicle Rest Active Study Product 4.1.1 Usage

Interventions

Radicle Rest Placebo Control Form 1 DIETARY_SUPPLEMENT

Participants will use their Radicle Rest Placebo Control Form 1 as directed for a period of 6 weeks.

Placebo Control 1

Radicle Rest Active Study Product 1.1 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle Rest Active Study Product 1.1 as directed for a period of 6 weeks.

Active Product 1.1

Radicle Rest Placebo Control Form 2 DIETARY_SUPPLEMENT

Participants will use their Radicle Rest Placebo Control Form 2 as directed for a period of 6 weeks.

Placebo Control 2

Radicle Rest Active Study Product 2.1 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle Rest Active Study Product 2.1 as directed for a period of 6 weeks.

Active Product 2.1

Radicle Rest Placebo Control 4.1.0 DIETARY_SUPPLEMENT

Participants will use their Radicle Rest Active Study Product 4.1.1 as directed for a period of 6 weeks.

Placebo Control 4.1.0

Radicle Rest Active Study Product 4.1.1 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle Rest Active Study Product 4.1.1 as directed for a period of 6 weeks.

Active Product 4.1.1

Eligibility Criteria

• Age: 21 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities. Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed
• Resides in the United States
• Endorses better sleep as a primary desire
• Has the opportunity for at least 20% improvement in their primary health outcome
• Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

You may not qualify if:

• Report being pregnant, trying to become pregnant, or breastfeeding
• Unable to provide a valid US shipping address and mobile phone number
• Reports current enrollment in another clinical trial
• Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
• Unable to read and understand English
• Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
• Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients. NYHA (New York Heart Association) Class Ill or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
• Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients. Anticoagulants, antihypertensive, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOls (monoamine oxidase inhibitors), or thyroid products
• Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products
• Lack of reliable daily access to the internet

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science, Inc

Del Mar, California, 92014, United States

Location

Related Links

• Radicle Science, Inc

MeSH Terms

Conditions

Parasomnias; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emily K. Pauli, PharmD

  Radicle Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will be stratified based on gender at birth then randomized to one of the study arms
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be stratified based on gender at birth then randomized to one of the study arms.

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 4, 2024
• Study Start: June 17, 2024
• Primary Completion: June 16, 2025
• Study Completion: June 16, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)