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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Anxiety, Stress

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 105 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be stratified based on gender at birth then randomized to one of the study arms
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |