Radicle Calm 2: A Study of Health and Wellness Products on Feelings of Anxiety, Stress, and Health Outcomes

Study Overview
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Brief Summary
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A randomized, double-blinded, placebo-controlled study assessing the impact of health and wellness products on feeling of anxiety, stress, and other health outcomes

Detailed Description
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This is a randomized, double-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 less anxiety or stress, (2) indicate an interest in taking a health and wellness product to potentially help their feelings of anxiety 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 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.

Official Title
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Radicle™ Calm 2: A Randomized, Double-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: Calm Active Study Product 1.1 Usage
* Dietary Supplement: Calm Active Study Product 1.2 Usage
* Dietary Supplement: Calm Active Study Product 1.3 Usage
* Dietary Supplement: Placebo Control Form 1
* Dietary Supplement: Placebo Control Form 2
* Dietary Supplement: Calm Active Study Product 2.1 Usage
* Dietary Supplement: Placebo Control Form 3
* Dietary Supplement: Calm Active Study Product 3.1 Usage
* Dietary Supplement: Placebo Control Form 4
* Dietary Supplement: Calm Active Study Product 4.1 Usage


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 fewer feelings of anxiety or stress as a primary desire Selects feelings of anxiety or stress, looking to improve their feelings of anxiety or 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: 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 MAOIs (monoamine oxidase inhibitors) Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: NYHA (New York Heart Association) Class III or IV congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias

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: Placebo Control Form 1<br>* Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.<br>|
| Experimental: Active Product 1.1<br>Calm Product Form 1 - active product 1 | Dietary Supplement: Calm Active Study Product 1.1 Usage<br>* Participants will use their Radicle Calm Active Study Product 1.1 as directed for a period of 6 weeks.<br>|
| Experimental: Active Product 1.2<br>Calm Product Form 1 - active product 2 | Dietary Supplement: Calm Active Study Product 1.2 Usage<br>* Participants will use their Radicle Calm Active Study Product 1.2 as directed for a period of 6 weeks.<br>|
| Experimental: Active Product 1.3<br>Calm Product Form 1 - active product 3 | Dietary Supplement: Calm Active Study Product 1.3 Usage<br>* Participants will use their Radicle Calm Active Study Product 1.3 as directed for a period of 6 weeks.<br>|
| Placebo Comparator: Placebo Control 2<br>Calm Product Form 2 - control | Dietary Supplement: Placebo Control Form 2<br>* Participants will use their Placebo Control Form 2 as directed for a period of 6 weeks.<br>|
| Experimental: Active Product 2.1<br>Calm Product Form 2 - active product 1 | Dietary Supplement: Calm Active Study Product 2.1 Usage<br>* Participants will use their Radicle Calm Active Study Product 2.1 as directed for a period of 6 weeks.<br>|
| Placebo Comparator: Placebo Control 3<br>Calm Product Form 3 - control | Dietary Supplement: Placebo Control Form 3<br>* Participants will use their Placebo Control Form 3 as directed for a period of 6 weeks.<br>|
| Experimental: Active Product 3.1<br>Calm Product Form 3 - active product 1 | Dietary Supplement: Calm Active Study Product 3.1 Usage<br>* Participants will use their Radicle Calm Active Study Product 3.1 as directed for a period of 6 weeks.<br>|
| Placebo Comparator: Placebo Control 4<br>Calm Product Form 4 - control | Dietary Supplement: Placebo Control Form 4<br>* Participants will use their Placebo Control Form 4 as directed for a period of 6 weeks.<br>|
| Experimental: Active Product 4.1<br>Calm Product Form 4 - active product 1 | Dietary Supplement: Calm Active Study Product 4.1 Usage<br>* Participants will use their Radicle Calm Active Study Product 4.1 as directed for a period of 6 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) | 6 weeks | 

Secondary 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 | 
| 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) | 6 weeks | 
| Change in sleep | Mean difference in sleep score as assessed by PROMIS Sleep Disturbance 4A (scale 4-20; where lower scores correspond to better sleep quality/less sleep disturbance) | 6 weeks | 
| 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) | 6 weeks | 
| Change in libido | Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; where lower scores correspond to less interest in sexual activity) | 6 weeks | 
| Minimal clinically important difference (MCID) in feelings of anxiety | Likelihood of achieving a MCID in sleep disturbance, as measured by PROMIS Anxiety 8A (scale 8-40; where lower scores correspond to less feelings of anxiety) | 6 weeks |