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

Not Applicable

Completed

• Conditions: Anxiety; Stress

• Registration Number: NCT05589948
• Lead Sponsor: Radicle Science

Brief Summary

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

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 Timeline

• Study Start: 2022-10-10
• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-21
• Primary Completion: 2023-05-03
• Study Completion: 2023-08-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1211

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in feelings of anxiety	4 weeks	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Radicle Science, Inc; 🇺🇸 Del Mar, California, United States