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

Back to results

Primary Purpose

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Rest Study Active Product 1.1 Usage

Rest Study Active Product 1.2 Usage

Rest Study Active Product 2.1 Usage

Rest Study Active Product 2.2 Usage

Placebo Control Form 1

Placebo Control Form 2

Placebo Control Form 3

Rest Study Active Product 3.1 Usage

Placebo Control Form 4

Rest Study Active Product 4.1 Usage

Rest Study Active Product 4.2 Usage

Rest Study Active Product 4.3 Usage

About this trial

This is an interventional other trial for Sleep

Eligibility Criteria

21 Years - 105 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Radicle Science, Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Placebo Control 1

Placebo Control 2

Active Product 1.1

Active Product 1.2

Active Product 2.1

Active Product 2.2

Placebo Control 3

Active Product 3.1

Placebo Control 4

Active Product 4.1

Active Product 4.2

Active Product 4.3

Arm Description

Rest Product Form 1 - control

Rest Product Form 2 - control

Rest Product Form 1 - active product 1

Rest Product Form 1 - active product 2

Rest Product Form 2 - active product 1

Rest Product Form 2 - active product 2

Rest Product Form 3 - control

Rest Product Form 3 - active product 1

Rest Product Form 4 - control

Rest Product Form 4 - active product 1

Rest Product Form 4 - active product 2

Rest Product Form 4 - active product 3

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

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)

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)

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)

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)

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)

Full Information

NCT ID

NCT05657808

First Posted

December 12, 2022

Last Updated

October 23, 2023

Sponsor

Radicle Science

1. Study Identification

Unique Protocol Identification Number

NCT05657808

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 9, 2023 (Actual)

Primary Completion Date

November 17, 2023 (Anticipated)

Study Completion Date

January 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Radicle Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep, Sleep Disturbance, Sleep Disorder

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantInvestigator

Masking Description

Participants will be blinded to the product they receive.

Allocation

Randomized

Enrollment

4152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo Control 1

Arm Type

Placebo Comparator

Arm Description

Rest Product Form 1 - control

Arm Title

Placebo Control 2

Arm Type

Placebo Comparator

Arm Description

Rest Product Form 2 - control

Arm Title

Active Product 1.1

Arm Type

Experimental

Arm Description

Rest Product Form 1 - active product 1

Arm Title

Active Product 1.2

Arm Type

Experimental

Arm Description

Rest Product Form 1 - active product 2

Arm Title

Active Product 2.1

Arm Type

Experimental

Arm Description

Rest Product Form 2 - active product 1

Arm Title

Active Product 2.2

Arm Type

Experimental

Arm Description

Rest Product Form 2 - active product 2

Arm Title

Placebo Control 3

Arm Type

Placebo Comparator

Arm Description

Rest Product Form 3 - control

Arm Title

Active Product 3.1

Arm Type

Experimental

Arm Description

Rest Product Form 3 - active product 1

Arm Title

Placebo Control 4

Arm Type

Placebo Comparator

Arm Description

Rest Product Form 4 - control

Arm Title

Active Product 4.1

Arm Type

Experimental

Arm Description

Rest Product Form 4 - active product 1

Arm Title

Active Product 4.2

Arm Type

Experimental

Arm Description

Rest Product Form 4 - active product 2

Arm Title

Active Product 4.3

Arm Type

Experimental

Arm Description

Rest Product Form 4 - active product 3

Intervention Type

Dietary Supplement

Intervention Name(s)

Rest Study Active Product 1.1 Usage

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Rest Study Active Product 1.2 Usage

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Rest Study Active Product 2.1 Usage

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Rest Study Active Product 2.2 Usage

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo Control Form 1

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo Control Form 2

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo Control Form 3

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Rest Study Active Product 3.1 Usage

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo Control Form 4

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Rest Study Active Product 4.1 Usage

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Rest Study Active Product 4.2 Usage

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Rest Study Active Product 4.3 Usage

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in sleep disturbance

Description

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)

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Change in fatigue

Description

Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; where higher scores correspond to more severe fatigue)

Time Frame

6 weeks

Title

Change in cognitive function

Description

Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 4A (scale 4-20; where higher scores correspond to greater cognitive function)

Time Frame

6 weeks

Title

Change in anxiety

Description

Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)

Time Frame

6 weeks

Title

Change in mood (emotional distress)

Description

Mean difference in mood score as assessed by PROMIS Depression 4A (scale 4-20; where higher scores correspond to more severe depression)

Time Frame

6 weeks

Title

Change in libido

Description

Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; where higher scores correspond to greater sexual interest)

Time Frame

6 weeks

Title

Minimal clinical importance difference (MCID) in sleep disturbance

Description

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)

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

105 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emily K. Pauli, PharmD

Organizational Affiliation

Radicle Science, Inc

Official's Role

Principal Investigator

Facility Information:

Facility Name

Radicle Science, Inc

City

Del Mar

State/Province

California

ZIP/Postal Code

92014

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

IPD Sharing Plan Description

Data will not be shared with researchers outside of Radicle Collaborators on this study.

Links:

URL

http://radiclescience.com

Description

Radicle Science, Inc

Sleep, Sleep Disturbance, Sleep Disorder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial