Radicle Relaxation 24: A Study of Health and Wellness Products on Stress and Related Health Outcomes

Radicle Relaxation™ 24: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Stress and Related Health Outcomes

A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on stress and related health outcomes

Study Overview

• Status: Active, not recruiting
• Conditions: Stress
• Intervention / Treatment: Dietary supplement: Placebo Control Form 1; Dietary supplement: Placebo Control Form 2; Dietary supplement: Relaxation Active Study Product 1.1; Dietary supplement: Relaxation Active Study Product 2.1

Detailed Description

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.

Eligible participants will (1) endorse a desire for less stress (2) have the opportunity for meaningful improvement (at least 20%) in their primary health outcome, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. 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 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.

• Study Type: Interventional
• Enrollment (Estimated): 1100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Del Mar, California, United States, 92014
      • Radicle Science, Inc

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Adults, at least 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities. Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed
• Resides in the United States
• Endorses less stress as a primary desire
• Has the opportunity for at least 20% 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

Exclusion Criteria:

• Reports 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
• 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 (New York Heart Association) Class Ill 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, MAOls (monoamine oxidase inhibitors), or thyroid products
• Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s)
• 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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Control 1; Relaxation Product Form 1 - control	Dietary supplement: Placebo Control Form 1; Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
Experimental: Active Product 1.1; Relaxation Product Form 1 - active product 1	Dietary supplement: Relaxation Active Study Product 1.1; Participants will use their Radicle Relaxation Active Study Product 1.1 as directed for a period of 6 weeks.
Placebo Comparator: Placebo Control 2; Relaxation Product Form 2 - control	Dietary supplement: Placebo Control Form 2; Participants will use their Placebo Control Form 2 as directed for a period of 6 weeks.
Experimental: Active Product 2.1; Relaxation Product Form 2 - active product 1	Dietary supplement: Relaxation Active Study Product 2.1; Participants will use their Radicle Relaxation Active Study Product 2.1 as directed for a period of 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in stress	Mean difference in stress score as assessed by National Institutes of Health (NIH) Toolbox Perceived Stress Survey (scale 10-50; where lower scores correspond to less stress)	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mood (emotional distress-depression)	Mean difference in emotional distress score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress)	6 weeks
Change in cognitive function	Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 4A (scale 4-20; where lower scores correspond to worse cognitive function)	6 weeks
Change in feelings of anxiety	Mean difference in anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)	6 weeks
Minimal clinically important difference (MCID) in stress	Likelihood of experiencing minimal clinically important difference in stress score as assessed by National Institutes of Health (NIH) Toolbox Perceived Stress Survey (scale 10-50; where lower scores correspond to less stress)	6 weeks
Minimal clinically important difference (MCID) in feelings of anxiety	Likelihood of experiencing minimal clinically important difference in anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)	6 weeks
Minimal clinically important difference (MCID) in cognitive function	Likelihood of experiencing minimal clinically important difference in cognitive function score as assessed by Patient Reported Outcome Measurement System (PROMIS) Cognitive Function 4A (scale 4-20; where lower scores correspond to worse cognitive function)	6 weeks
Minimal clinically important difference (MCID) in mood (emotional distress-depression)	Likelihood of experiencing minimal clinically important difference in emotional distress score as assessed by Patient Reported Outcome Measurement System (PROMIS) Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress)	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in concentration of at-home (direct-to-consumer) specimen assays either saliva, blood or stool	Mean difference in specimen assays as surrogates and/or markers for health outcomes. (Optional; among consented participants only) Potentially include saliva (IgG, cytokines, DHEA-S, Estradiol, Progesterone, Testosterone, Cortisol, Melatonin, CRP) blood all in one panel 1 outcome (1 drop) (Cortisol, Homocysteine, Ferritin, TSH, HbA1c, Insulin, Vitamin D, DHEA-S, Testosterone, Estradiol, FSH, Total Cholesterol, HDL, LDL, Triglycerides, ApoA1, ApoB). Stool (microbial diversity). Values will vary based on optional biomarker selected	6 weeks

Collaborators and Investigators

• Sponsor: Radicle Science
• Investigators: Principal Investigator: Emily K. Pauli, PharmD, Radicle Science, Inc

Publications and helpful links

Helpful Links

• Radicle Science, Inc

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RADX-P-2408

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