Radicle RestTM VGI: A Study Assessing the Impact of Health and Wellness Products on Sleep and Related Health Outcomes

NCT07744997 | Not Yet Recruiting

• 1 other identifier: RADX_P_2601_VGI
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep Disturbance

Outcome Measures

Primary Outcomes (1)

• Change in sleep

  Change in sleep: Difference in rates of change over time in sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance)

  7 weeks

Secondary Outcomes (3)

• Change in sleep-related impairment

  7 weeks

• Change in mood (emotional distress-depression)

  7 weeks

• Change in fatigue

  7 weeks

Other Outcomes (7)

• Minimal clinically important difference (MCID) in sleep

  7 weeks

• Minimal clinically important difference (MCID) in mood (emotional distress-depression)

  7 weeks

• Minimal clinically important difference (MCID) in sleep

  7 weeks

Study Arms (2)

Active Rest Product 1

EXPERIMENTAL

Active Rest Product 1

Dietary Supplement: Active Rest Product 1

Placebo Rest Control

PLACEBO COMPARATOR

Placebo Rest Control

Dietary Supplement: Placebo Rest Control

Interventions

Placebo Rest Control DIETARY_SUPPLEMENT

Participants will use their Placebo Rest Control as directed for a period of 6 weeks

Placebo Rest Control

Active Rest Product 1 DIETARY_SUPPLEMENT

Participants will use their Active Rest Product 1 as directed for a period of 6 weeks

Active Rest Product 1

Eligibility Criteria

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

3.1 Inclusion Participants must meet all the following criteria: * 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 PROs (male vs female) employed, when needed * Resides in the United States * Has the opportunity for at least 30% 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 3.2 Exclusion Individuals who report any of the following during screening may be excluded from participation: * 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 at a 7th grade level * 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 Class III 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, antihypertensives, 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, MAOIs, 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 and/or pose a safety risk * Lack of reliable daily access to the internet

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science Inc.

Del Mar, California, 92014-2605, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Susan Hewlings

  Radicle Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Manager

CONTACT

858-779-0086; studymgmt@radiclescience.com

Susan Hewlings

CONTACT

760-281-3898; susan.hewlings@radiclescience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible participants must complete all enrollment procedures before stratification and randomization. During enrollment, participants will be stratified by sex assigned at birth, age, and health outcome score, with health outcome scores categorized according to the applicable PROMIS® published scoring guidelines. Participants will then be sequentially randomized to a study group using all stratification factors collectively to ensure balanced allocation across study product groups. Stratification factors include sex assigned at birth (Female, Non-Female), age (21-44, 45-64, 65+ years), and four health outcome score categories, resulting in 24 unique stratification cells (2 × 3 × 4 = 24). Following randomization, participants will receive their assigned study product and an insert containing instructions for product use and study procedures.

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): August 6, 2026
• Primary Completion (Estimated): August 6, 2027
• Study Completion (Estimated): August 6, 2027
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)