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

Radicle Science

Status: Completed

Conditions: Sleep Disorder; Sleep Disturbance; Sleep

Treatments: Dietary Supplement: Rest Study Active Product 1.2 Usage; Dietary Supplement: Placebo Control Form 2; Dietary Supplement: Placebo Control Form 1; Dietary Supplement: Rest Study Active Product 4.2 Usage; Dietary Supplement: Placebo Control Form 4; Dietary Supplement: Rest Study Active Product 4.1 Usage; Dietary Supplement: Rest Study Active Product 2.1 Usage; Dietary Supplement: Rest Study Active Product 1.1 Usage; Dietary Supplement: Rest Study Active Product 2.2 Usage; Dietary Supplement: Placebo Control Form 3; Dietary Supplement: Rest Study Active Product 4.3 Usage; Dietary Supplement: Rest Study Active Product 3.1 Usage

Study type: Interventional

Funder types: Industry

Identifiers

NCT05657808

RADX-2301

Details and patient eligibility

About

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

Full 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.

Enrollment: 4,152 patients

Sex: All

Ages: 21 to 105 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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4,152 participants in 12 patient groups, including a placebo group

Placebo Control 1

Placebo Comparator group

Description:

Rest Product Form 1 - control

Treatment:

Dietary Supplement: Placebo Control Form 1

Placebo Control 2

Placebo Comparator group

Description:

Rest Product Form 2 - control

Treatment:

Dietary Supplement: Placebo Control Form 2

Active Product 1.1

Experimental group

Description:

Rest Product Form 1 - active product 1

Treatment:

Dietary Supplement: Rest Study Active Product 1.1 Usage

Active Product 1.2

Experimental group

Description:

Rest Product Form 1 - active product 2

Treatment:

Dietary Supplement: Rest Study Active Product 1.2 Usage

Active Product 2.1

Experimental group

Description:

Rest Product Form 2 - active product 1

Treatment:

Dietary Supplement: Rest Study Active Product 2.1 Usage

Active Product 2.2

Experimental group

Description:

Rest Product Form 2 - active product 2

Treatment:

Dietary Supplement: Rest Study Active Product 2.2 Usage

Placebo Control 3

Placebo Comparator group

Description:

Rest Product Form 3 - control

Treatment:

Dietary Supplement: Placebo Control Form 3

Active Product 3.1

Experimental group

Description:

Rest Product Form 3 - active product 1

Treatment:

Dietary Supplement: Rest Study Active Product 3.1 Usage

Placebo Control 4

Placebo Comparator group

Description:

Rest Product Form 4 - control

Treatment:

Dietary Supplement: Placebo Control Form 4

Active Product 4.1

Experimental group

Description:

Rest Product Form 4 - active product 1

Treatment:

Dietary Supplement: Rest Study Active Product 4.1 Usage

Active Product 4.2

Experimental group

Description:

Rest Product Form 4 - active product 2

Treatment:

Dietary Supplement: Rest Study Active Product 4.2 Usage

Active Product 4.3

Experimental group

Description:

Rest Product Form 4 - active product 3

Treatment:

Dietary Supplement: Rest Study Active Product 4.3 Usage