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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05657808
• Other study ID #: RADX-2301
• Status: Completed
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: April 15, 2024

Study information

• Verified date: May 2024
• Source: Radicle Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4152
• Est. completion date: April 15, 2024
• Est. primary completion date: December 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep
• Sleep Disorder
• Sleep Disturbance
• Sleep Wake Disorders

Intervention

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.
• Rest Study Active Product 1.2 Usage
Participants will use Radicle Rest Active Product 1.2 as directed for a period of 6 weeks.
• Rest Study Active Product 2.1 Usage
Participants will use Radicle Rest Active Product 2.1 as directed for a period of 6 weeks.
• Rest Study Active Product 2.2 Usage
Participants will use Radicle Rest Active Product 2.2 as directed for a period of 6 weeks.
• Placebo Control Form 1
Participants will use Placebo Control Form 1 as directed for a period of 6 weeks.
• Placebo Control Form 2
Participants will use Placebo Control Form 2 as directed for a period of 6 weeks.
• Placebo Control Form 3
Participants will use Placebo Control Form 3 as directed for a period of 6 weeks.
• 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 Control Form 4
Participants will use Placebo Control Form 4 as directed for a period of 6 weeks.
• Rest Study Active Product 4.1 Usage
Participants will use Radicle Rest Active Product 4.1 as directed for a period of 6 weeks.
• Rest Study Active Product 4.2 Usage
Participants will use Radicle Rest Active Product 4.2 as directed for a period of 6 weeks.
• Rest Study Active Product 4.3 Usage
Participants will use Radicle Rest Active Product 4.3 as directed for a period of 6 weeks.

Locations

Country	Name	City	State
United States	Radicle Science, Inc	Del Mar	California

Sponsors (1)

Lead Sponsor	Collaborator
Radicle Science

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Radicle Science, Inc