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

NCT05657808 | Completed

• 1 other identifier: RADX-2301
• Study Type: interventional
• Target: 4,152
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Sleep Disturbance; Sleep Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in fatigue

  6 weeks

• Change in cognitive function

  6 weeks

• Change in anxiety

  6 weeks

• Change in mood (emotional distress)

  6 weeks

• Change in libido

  6 weeks

Study Arms (12)

Placebo Control 1

PLACEBO COMPARATOR

Rest Product Form 1 - control

Dietary Supplement: Placebo Control Form 1

Placebo Control 2

PLACEBO COMPARATOR

Rest Product Form 2 - control

Dietary Supplement: Placebo Control Form 2

Active Product 1.1

EXPERIMENTAL

Rest Product Form 1 - active product 1

Dietary Supplement: Rest Study Active Product 1.1 Usage

Active Product 1.2

EXPERIMENTAL

Rest Product Form 1 - active product 2

Dietary Supplement: Rest Study Active Product 1.2 Usage

Active Product 2.1

EXPERIMENTAL

Rest Product Form 2 - active product 1

Dietary Supplement: Rest Study Active Product 2.1 Usage

Active Product 2.2

EXPERIMENTAL

Rest Product Form 2 - active product 2

Dietary Supplement: Rest Study Active Product 2.2 Usage

Placebo Control 3

PLACEBO COMPARATOR

Rest Product Form 3 - control

Dietary Supplement: Placebo Control Form 3

Active Product 3.1

EXPERIMENTAL

Rest Product Form 3 - active product 1

Dietary Supplement: Rest Study Active Product 3.1 Usage

Placebo Control 4

PLACEBO COMPARATOR

Rest Product Form 4 - control

Dietary Supplement: Placebo Control Form 4

Active Product 4.1

EXPERIMENTAL

Rest Product Form 4 - active product 1

Dietary Supplement: Rest Study Active Product 4.1 Usage

Active Product 4.2

EXPERIMENTAL

Rest Product Form 4 - active product 2

Dietary Supplement: Rest Study Active Product 4.2 Usage

Active Product 4.3

EXPERIMENTAL

Rest Product Form 4 - active product 3

Dietary Supplement: Rest Study Active Product 4.3 Usage

Interventions

Rest Study Active Product 1.1 Usage DIETARY_SUPPLEMENT

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

Active Product 1.1

Rest Study Active Product 1.2 Usage DIETARY_SUPPLEMENT

Participants will use Radicle Rest Active Product 1.2 as directed for a period of 6 weeks.

Active Product 1.2

Rest Study Active Product 2.1 Usage DIETARY_SUPPLEMENT

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

Active Product 2.1

Rest Study Active Product 2.2 Usage DIETARY_SUPPLEMENT

Participants will use Radicle Rest Active Product 2.2 as directed for a period of 6 weeks.

Active Product 2.2

Placebo Control Form 1 DIETARY_SUPPLEMENT

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

Placebo Control 1

Placebo Control Form 2 DIETARY_SUPPLEMENT

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

Placebo Control 2

Placebo Control Form 3 DIETARY_SUPPLEMENT

Participants will use Placebo Control Form 3 as directed for a period of 6 weeks.

Placebo Control 3

Rest Study Active Product 3.1 Usage DIETARY_SUPPLEMENT

Participants will use Radicle Rest Active Product 3.1 as directed for a period of 6 weeks.

Active Product 3.1

Placebo Control Form 4 DIETARY_SUPPLEMENT

Participants will use Placebo Control Form 4 as directed for a period of 6 weeks.

Placebo Control 4

Rest Study Active Product 4.1 Usage DIETARY_SUPPLEMENT

Participants will use Radicle Rest Active Product 4.1 as directed for a period of 6 weeks.

Active Product 4.1

Rest Study Active Product 4.2 Usage DIETARY_SUPPLEMENT

Participants will use Radicle Rest Active Product 4.2 as directed for a period of 6 weeks.

Active Product 4.2

Rest Study Active Product 4.3 Usage DIETARY_SUPPLEMENT

Participants will use Radicle Rest Active Product 4.3 as directed for a period of 6 weeks.

Active Product 4.3

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, 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

You may not qualify if:

• 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

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: The investigator is blinded to the participants' study product assignment. Participants are blinded to the study product they are assigned.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 20, 2022
• Study Start: January 9, 2023
• Primary Completion: December 4, 2023
• Study Completion: April 15, 2024
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)