Radicle GI Health: A Study of Health and Wellness Products on GI Health and Other Health Outcomes

Study Overview
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Brief Summary
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A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on gastrointestinal (GI) health 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 less bloating or indigestion, (2) indicate an interest in taking a health and wellness product to potentially help their bloating or indigestion, 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™ GI Health: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Gastrointestinal (GI) Health and Other Health Outcomes

Conditions
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Digestion, Abdominal Pain, GI Disorders

Intervention / Treatment
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* Dietary Supplement: Radicle GI Health Placebo Control Form 1
* Dietary Supplement: Radicle GI Health Active Study Product 1.1 Usage
* Dietary Supplement: Radicle GI Health Placebo Control Form 2
* Dietary Supplement: Radicle GI Health Active Study Product 2.1 Usage
* Dietary Supplement: Radicle GI Health Active Study Product 2.2 Usage
* Dietary Supplement: Radicle GI Health Placebo Control Form 3
* Dietary Supplement: Radicle GI Health Active Study Product 3.1 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, and gender identities Resides in the United States Endorses less bloating or indigestion as a primary desire Has the opportunity for at least 20% improvement in their primary health outcome score 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 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 another 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, antihypertensives, anti-anxiolytics, antidepressants, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs (monoamine oxidase inhibitors), or thyroid products Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: NYHAA (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>GI Health Product Form 1 - control | Dietary Supplement: Radicle GI Health 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>GI Health Product Form 1 - active product 1 | Dietary Supplement: Radicle GI Health Active Study Product 1.1 Usage<br>* Participants will use their Radicle GI Health Active Study Product 1.1 as directed for a period of 6 weeks.<br>|
| Placebo Comparator: Placebo Control 2<br>GI Health Product Form 2 - control | Dietary Supplement: Radicle GI Health Placebo Control Form 2<br>* Participants will use their Radicle GI Health Placebo Control Form 2 as directed for a period of 6 weeks.<br>|
| Experimental: Active Product 2.1<br>GI Health Product Form 2 - active product 1 | Dietary Supplement: Radicle GI Health Active Study Product 2.1 Usage<br>* Participants will use their Radicle GI Health Active Study Product 2.1 as directed for a period of 6 weeks.<br>|
| Experimental: Active Product 2.2<br>GI Health Product Form 2 - active product 2 | Dietary Supplement: Radicle GI Health Active Study Product 2.2 Usage<br>* Participants will use their Radicle GI Health Active Study Product 2.2 as directed for a period of 6 weeks.<br>|
| Placebo Comparator: Placebo Control 3<br>GI Health Product Form 3 - control | Dietary Supplement: Radicle GI Health Placebo Control Form 3<br>* Participants will use their Radicle GI Health Placebo Control Form 3 as directed for a period of 6 weeks.<br>|
| Experimental: Active Product 3.1<br>GI Health Product Form 3 - active product 1 | Dietary Supplement: Radicle GI Health Active Study Product 3.1 Usage<br>* Participants will use their Radicle GI Health Active Study Product 3.1 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 GI (Gastrointestinal) - related Quality of Life (QOL) | Mean difference in GI-related QOL as assessed by Digestion-associated QOL Questionnaire (DGLQ) (scale 0%-100%; with higher scores corresponding to worse GI-related QOL) | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in abdominal pain | Mean difference in abdominal pain as assessed by Patient Reported Outcome Measurement System (PROMIS) Belly Pain 5A (scale 2-25; with higher scores corresponding to more severe abdominal pain) | 6 weeks | 
| Change in gas/bloating | Mean Difference in Gas/Bloating as assessed by PROMIS GI Gas and Bloating 13A (scale 2-60; with higher scores corresponding to more severe gas/bloating) | 6 weeks | 
| Change in feelings of 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 | 
| Minimal clinically important difference (MCID) in GI-related QOL | Likelihood of experiencing MCID in GI-related QOL as assessed by Digestion-associated QOL Questionnaire (DGLQ) | 6 weeks | 
| Minimal clinically important difference (MCID) in abdominal pain | Likelihood of experiencing MCID in abdominal pain as assessed by PROMIS Belly Pain 5A | 6 weeks | 
| Minimal clinically important difference (MCID) in gas/bloating | Likelihood of experiencing MCID in gas/bloating PROMIS GI Gas and Bloating 13A | 6 weeks |