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

Radicle RestTM VGI: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Sleep and Related Health Outcomes

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

Study Overview

• Status: Active, not recruiting
• Conditions: Sleep Disturbance
• Intervention / Treatment: Dietary supplement: Active Rest Product 1; Dietary supplement: Placebo Rest Control

Detailed Description

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants will (1) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (2) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.

Self-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. 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): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Del Mar, California, United States, 92014-2605
      • Radicle Science Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Rest Product 1	Dietary supplement: Active Rest Product 1; Participants will use their Active Rest Product 1 as directed for a period of 6 weeks
Placebo Comparator: Placebo Rest Control	Dietary supplement: Placebo Rest Control; Participants will use their Placebo Rest Control 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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fatigue	Change in fatigue: Difference in rates of change over time in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)	7 weeks
Change in sleep-related impairment	Change in sleep-related impairment: Difference between rates of change over time in sleep score as assessed by PROMIS Sleep-Related Impairment 8a (scale 8-40; where the higher scores correspond to worse sleep)	7 weeks
Change in mood (emotional distress-depression)	Change in mood (emotional distress-depression): Difference in rates of change over time in emotional distress score as assessed by PROMIS Emotional Distress- Depression 8A (scale 8-40; with higher scores corresponding to greater levels of emotional distress)	7 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal clinically important difference (MCID) in sleep	Minimal clinically important difference (MCID) in sleep: Likelihood of experiencing minimal clinically important difference 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
Change in cognitive function	Change in cognitive function: Difference in rates of change over time in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; where lower scores correspond to worse cognitive function)	7 weeks
Minimal clinically important difference (MCID) in cognitive function	Minimal clinically important difference (MCID) in cognitive function: Likelihood of experiencing minimal clinically important difference in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; where lower scores correspond to worse cognitive function)	7 weeks
Minimal clinically important difference (MCID) in sleep	Minimal clinically important difference (MCID) in sleep: Likelihood of experiencing minimal clinically important difference in sleep score, as measured by PROMIS Sleep-Related Impairment 8a (scale 8-40; where the higher scores correspond to worse sleep)	7 weeks
Change in feelings of anxiety	Change in feelings of anxiety: Difference between rates of change over time in feelings of anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)	7 weeks
Minimal clinically important difference (MCID) in feelings of anxiety	Minimal clinically important difference (MCID) in feelings of anxiety: Likelihood of experiencing minimal clinically important difference in feelings of anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)	7 weeks
Minimal clinically important difference (MCID) in mood (emotional distress-depression)	Minimal clinically important difference (MCID) in mood (emotional distress-depression): Likelihood of experiencing minimal clinically important difference in mood score as assessed by PROMIS Emotional Distress- Depression 8A (scale 8-40; with higher scores corresponding to greater levels of emotional distress)	7 weeks

Collaborators and Investigators

• Sponsor: Radicle Science
• Investigators: Principal Investigator: Susan Hewlings, Radicle Science

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2026
• Primary Completion (Estimated): August 6, 2027
• Study Completion (Estimated): August 6, 2027

Study Registration Dates

• First Submitted: July 29, 2026
• First Submitted That Met QC Criteria: July 29, 2026
• First Posted (Actual): August 4, 2026

Study Record Updates

• Last Update Posted (Actual): September 2, 2026
• Last Update Submitted That Met QC Criteria: September 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: RADX_P_2601_VGI

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