Radicle Clarity: A Study of Health and Wellness Products on Mental Clarity and Health Outcomes

Study Overview
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Brief Summary
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A randomized, blinded, placebo-controlled direct-to-consumer study of health and wellness products on mental clarity and other health outcomes

Detailed Description
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This is a randomized, 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 better concentration, (2) indicate an interest in taking a health and wellness product to potentially help their concentration, 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™ Clarity: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Cognitive Function and Other Health Outcomes

Conditions
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Cognitive Function

Intervention / Treatment
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* Dietary Supplement: Clarity Active Study Product 1.1 Usage
* Dietary Supplement: Clarity Active Study Product 2.1 Usage
* Dietary Supplement: Clarity Active Study Product 3.1 Usage
* Dietary Supplement: Clarity Active Study Product 4.1 Usage
* Dietary Supplement: Clarity Active Study Product 4.2 Usage
* Dietary Supplement: Clarity Active Study Product 4.3 Usage
* Dietary Supplement: Placebo Control Form 1
* Dietary Supplement: Placebo Control Form 2
* Dietary Supplement: Placebo Control Form 3
* Dietary Supplement: Placebo Control Form 4
* Dietary Supplement: Placebo Control Form 5
* Dietary Supplement: Clarity Active Study Product 5.1 Usage
* Dietary Supplement: Clarity Active Study Product 5.2 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 better concentration as a primary desire Selects concentration and/or looking to improve their concentration 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 and mobile phone number The calculated validated health survey (PRO) score during enrollment represents less than mild impairment or severity 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 or immunotherapy Reports taking medications with a known moderate or severe interaction with any of the active ingredients studied or a substantial safety risk: Anticoagulants, a medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, 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 arm
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Control 1<br>Clarity 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>|
| Placebo Comparator: Placebo Control 2<br>Clarity 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>|
| Placebo Comparator: Placebo Control 3<br>Clarity 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>|
| Placebo Comparator: Placebo Control 4<br>Clarity 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 1.1<br>Clarity Product Form 1 - active product 1 | Dietary Supplement: Clarity Active Study Product 1.1 Usage<br>* Participants will use their Radicle Clarity Active Study Product 1.1 as directed for a period of 6 weeks.<br>|
| Experimental: Active Product 2.1<br>Clarity Product Form 2 - active product 1 | Dietary Supplement: Clarity Active Study Product 2.1 Usage<br>* Participants will use their Radicle Clarity Active Study Product 2.1 as directed for a period of 6 weeks.<br>|
| Experimental: Active Product 3.1<br>Clarity Product Form 3 - active product 1 | Dietary Supplement: Clarity Active Study Product 3.1 Usage<br>* Participants will use their Radicle Clarity Active Study Product 3.1 as directed for a period of 6 weeks.<br>|
| Experimental: Active Product 4.1<br>Clarity Product Form 4 - active product 1 | Dietary Supplement: Clarity Active Study Product 4.1 Usage<br>* Participants will use their Radicle Clarity Active Study Product 4.1 as directed for a period of 6 weeks.<br>|
| Experimental: Active Product 4.2<br>Clarity Product Form 4 - active product 2 | Dietary Supplement: Clarity Active Study Product 4.2 Usage<br>* Participants will use their Radicle Clarity Active Study Product 4.2 as directed for a period of 6 weeks.<br>|
| Experimental: Active Product 4.3<br>Clarity Product Form 4 - active product 3 | Dietary Supplement: Clarity Active Study Product 4.3 Usage<br>* Participants will use their Radicle Clarity Active Study Product 4.3 as directed for a period of 6 weeks.<br>|
| Placebo Comparator: Placebo Control 5<br>Clarity Product Form 5 - control | Dietary Supplement: Placebo Control Form 5<br>* Participants will use their Placebo Control Form 5 as directed for a period of 6 weeks.<br>|
| Experimental: Active Product 5.1<br>Clarity Product Form 5 - active product 1 | Dietary Supplement: Clarity Active Study Product 5.1 Usage<br>* Participants will use their Radicle Clarity Active Study Product 5.1 as directed for a period of 6 weeks.<br>|
| Experimental: Active Product 5.2<br>Clarity Product Form 5 - active product 2 | Dietary Supplement: Clarity Active Study Product 5.2 Usage<br>* Participants will use their Radicle Clarity Active Study Product 5.2 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 cognition (mental clarity) | Mean difference in cognition score as assessed by Patient Reported Outcome Measurement System (PROMIS) Cognitive Function Short Form 8A (scale 8-40; where the higher scores correspond to greater cognitive function) | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in executive functioning | Mean difference in cognition score as assessed by Adult Executive Functioning Inventory (ADEXI) (scale 1-5; with higher scores corresponding to lower executive functioning) | 6 weeks | 
| Change in sleep quality | Mean difference in sleep quality score as assessed by PROMIS Sleep Disturbance 4A (scale 4-20; with higher scores corresponding to greater sleep disturbance) | 6 weeks | 
| Change in energy (fatigue) | Mean difference in energy score as assessed by PROMIS Fatigue 4A (scale 4-20; where higher scores correspond to more severe fatigue) | 6 weeks | 
| Change in anxiety | Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety) | 6 weeks | 
| Change in mood (emotional distress) | Mean difference in mood score as assessed by PROMIS Depression 4A (scale 4-20; where higher scores correspond to more severe depression) | 6 weeks | 
| Change in libido | Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; where higher scores correspond to greater sexual interest) | 6 weeks | 
| Minimal clinical importance difference (MCID) in cognitive function | Likelihood of achieving a MCID in cognitive function, as measured by PROMIS Cognitive Function Short Form 8A (scale 8-40; where the higher scores correspond to greater cognitive function) | 6 weeks |