Radicle Calm 1: A Study of Health and Wellness Products on Feelings of Anxiety, Stress and Other Health Outcomes

Radicle™ Calm 1: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Feelings of Anxiety, Stress and Other Health Outcomes

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

Study Overview

• Status: Completed
• Conditions: Stress; Anxiety
• Intervention / Treatment: Dietary supplement: Radicle Calm Study Placebo Control 1; Dietary supplement: Radicle Calm Study Placebo Control 2; Dietary supplement: Radicle Calm Study Active Product 1.1; Dietary supplement: Radicle Calm Study Active Product 2.1; Dietary supplement: Radicle Calm Study Active Product 2.2

Detailed Description

This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult participants per study arm, age 21 and older and residing in the United States.

Eligible participants will (1) endorse a desire for less feelings of anxiety and/or stress, (2) indicate an interest in taking a health and wellness product to potentially improve their anxiety and/or stress, 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 are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded.

Self-reported data will be collected electronically from eligible participants over 5 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 (Actual): 1211
• 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: 21 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 feelings of anxiety or stress as a primary issue (desire to reduce anxiety or less stress)
• Selects feelings of anxiety/stress, looking to improve their feelings of anxiety/stress, 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:

• Pregnant, trying to become pregnant, or breastfeeding
• Unable to provide a valid physical shipping address
• 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
• Lack of reliable daily access to the internet
• Reports taking anticoagulants, any medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, or MAOIs (monoamine oxidase inhibitors)
• Reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Control 1; Calm Product Form 1 - control	Dietary supplement: Radicle Calm Study Placebo Control 1; Participants will use their Radicle Calm Placebo Control Product 1 as directed for a period of 4 weeks.
Placebo Comparator: Placebo Control 2; Calm Product Form 2 - control	Dietary supplement: Radicle Calm Study Placebo Control 2; Participants will use their Radicle Calm Placebo Control Product 2 as directed for a period of 4 weeks.
Experimental: Active Product 1.1; Calm Product Form 1 - active product 1	Dietary supplement: Radicle Calm Study Active Product 1.1; Participants will use their Radicle Calm Active Product 1.1 as directed for a period of 4 weeks.
Experimental: Active Product 2.1; Calm Product Form 2 - active product 1	Dietary supplement: Radicle Calm Study Active Product 2.1; Participants will use their Radicle Calm Active Product 2.1 as directed for a period of 4 weeks.
Experimental: Active Product 2.2; Calm Product Form 2 - active product 2	Dietary supplement: Radicle Calm Study Active Product 2.2; Participants will use their Radicle Calm Active Product 2.2 as directed for a period of 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in feelings of anxiety	Mean difference in feelings of anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 8A (scale 8-40; where lower scores correspond to less feelings of anxiety)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal clinically important difference (MCID) in anxiety	Likelihood of experiencing a MCID in anxiety score as assessed by PROMIS Anxiety 8A	4 weeks
Change in stress	Mean difference in stress score as assessed by PROMIS Stress 8A (scale 8-40; where lower scores correspond to less stress)	4 weeks
Minimal clinically important difference (MCID) in stress	Likelihood of experiencing a MCID in stress score as assessed by PROMIS Stress 8A	4 weeks
Change in sleep disturbance	Mean difference in sleep disturbance score as assessed by PROMIS Sleep 4A (scale 4-20; where lower scores correspond to better sleep quality/less sleep disturbance)	4 weeks
Change in cognitive function	Mean difference in cognitive function score as assessed by PROMIS Cognition Function 4A (scale 4-20; where lower scores correspond to poorer cognitive function)	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mood (emotional distress)	Mean difference in mood score as assessed by PROMIS Emotional Distress-Depression 4A (scale 4-20; where lower scores correspond to lower levels of emotional distress)	4 weeks
Change in libido	Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 4-20; where lower scores correspond to less interest in sexual activity)	4 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): October 10, 2022
• Primary Completion (Actual): May 3, 2023
• Study Completion (Actual): August 15, 2023

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: RADX-22D04

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