Radicle GI Health 24: A Study of Health and Wellness Products on GI Health and Related Health Outcomes
- Conditions
- GI DisordersAbdominal PainDigestion
- Interventions
- Dietary Supplement: Radicle GI Health Placebo Control Form 3Dietary Supplement: Radicle GI Health Active Study Product 3.1 UsageDietary Supplement: Radicle GI Health Placebo Control Form 4Dietary Supplement: Radicle GI Health Active Study Product 4.1 UsageDietary Supplement: Radicle GI Health Placebo Control Form 5Dietary Supplement: Radicle GI Health Active Study Product 5.1 UsageDietary Supplement: Radicle GI Health Active Study Product 1.1 UsageDietary Supplement: Radicle GI Health Placebo Control Form 2Dietary Supplement: Radicle GI Health Placebo Control Form 1Dietary Supplement: Radicle GI Health Active Study Product 2.1 Usage
- Registration Number
- NCT06376695
- Lead Sponsor
- Radicle Science
- Brief Summary
A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI health and related health outcomes
- Detailed Description
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.
Eligible participants will (1) endorse a desire for improved bowel habits, less bloating/indigestion, and/or fewer stomach aches/pains (2) have the opportunity for meaningful improvement (at least 20%) in their primary health outcome, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.
Self-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2100
- Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities. Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed
- Resides in the United States
- Endorses a desire for improved bowel habits, less bloating/indigestion, and/or fewer stomach aches/pains
- Has the opportunity for at least 20% improvement in their primary health outcome
- Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study
- Report being pregnant, trying to become pregnant, or breastfeeding
- Unable to provide a valid US shipping address and mobile phone number
- Reports current enrollment in another clinical trial
- Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
- Unable to read and understand English
- Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
- Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients. NYHA (New York Heart Association) Class Ill or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
- Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients. Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOls (monoamine oxidase inhibitors), or thyroid products
- Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study product
- Lack of reliable daily access to the internet
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Control 3 Radicle GI Health Placebo Control Form 3 GI Health Product Form 3 - control Active Product 3.1 Radicle GI Health Active Study Product 3.1 Usage GI Health Product Form 3 - active product 1 Placebo Control 4 Radicle GI Health Placebo Control Form 4 GI Health Product Form 4 - control Active Product 4.1 Radicle GI Health Active Study Product 4.1 Usage GI Health Product Form 4 - active product 1 Placebo Control 5 Radicle GI Health Placebo Control Form 5 GI Health Product Form 5 - control Active Product 5.1 Radicle GI Health Active Study Product 5.1 Usage GI Health Product Form 5 - active product 1 Active Product 1.1 Radicle GI Health Active Study Product 1.1 Usage GI Health Product Form 1 - active product 1 Placebo Control 2 Radicle GI Health Placebo Control Form 2 GI Health Product Form 2 - control Placebo Control 1 Radicle GI Health Placebo Control Form 1 GI Health Product Form 1 - control Active Product 2.1 Radicle GI Health Active Study Product 2.1 Usage GI Health Product Form 2 - active product 1
- Primary Outcome Measures
Name Time Method Change in GI (Gastrointestinal) Health (2) 6 weeks Mean difference in Gastrointestinal Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Gas and Bloating 13A (scale 2-60; with higher scores corresponding to more severe gas/bloating)
Change in GI (Gastrointestinal) Health (5) 6 weeks Mean difference in GI Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Gastroesophageal Reflux 13A (scale 8-64; with higher scores corresponding to more severe reflux)
Change in GI (Gastrointestinal) Health (1) 6 weeks Mean difference in Gastrointestinal Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Belly Pain 5A (scale 2-25; with higher scores corresponding to more severe abdominal pain)
Change in GI (Gastrointestinal) Health (4) 6 weeks Mean difference in GI Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Diarrhea 6A (scale 2-30; with higher scores corresponding to more severe diarrhea)
Change in GI (Gastrointestinal) Health (3) 6 weeks Mean difference in GI Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Constipation 9A (scale 5-45; with higher scores corresponding to more severe constipation)
Change in GI (Gastrointestinal) Health (6) 6 weeks Mean difference in GI Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Nausea and Vomiting 4A (scale 3-20; with higher scores corresponding to more severe nausea and vomiting)
- Secondary Outcome Measures
Name Time Method Minimal clinically important difference (MCID) in GI Health (3) 6 weeks Likelihood of experiencing minimal clinically important difference in GI Health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Constipation 9A (scale 5-45; with higher scores corresponding to more severe constipation)
Minimal clinically important difference (MCID) in GI Health (4) 6 weeks Likelihood of experiencing minimal clinically important difference in GI Health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Diarrhea 6A (scale 2-30; with higher scores corresponding to more severe diarrhea)
Minimal clinically important difference (MCID) in feelings of anxiety 6 weeks Likelihood of experiencing minimal clinically important difference in feelings of anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)
Change in feelings of anxiety 6 weeks Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)
Minimal clinically important difference (MCID) in GI Health (1) 6 weeks Likelihood of experiencing minimal clinically important difference in GI Health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Belly Pain 5A (scale 2-25; with higher scores corresponding to more severe abdominal pain)
Minimal clinically important difference (MCID) in GI Health (2) 6 weeks Likelihood of experiencing minimal clinically important difference in GI Health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Gas and Bloating 13A (scale 2-60; with higher scores corresponding to more severe gas/bloating)
Change in GI-related Quality of Life (QOL) 6 weeks 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)
Change in mood (emotional distress-depression) 6 weeks Mean difference in emotional distress score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress)
Minimal clinically important difference (MCID) in GI Health (6) 6 weeks Likelihood of experiencing minimal clinically important difference in GI Health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Nausea and Vomiting 4A (scale 3-20; with higher scores corresponding to more severe nausea and vomiting)
Minimal clinically important difference (MCID) in GI-related QOL 6 weeks Likelihood of experiencing minimal clinically important difference in GI-related QOL score as assessed by Digestion-associated QOL Questionnaire (DGLQ) (scale 0%-100%; with higher scores corresponding to worse GI-related QOL)
Minimal clinically important difference (MCID) in mood (emotional distress-depression) 6 weeks Likelihood of experiencing minimal clinically important difference in mood score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress)
Minimal clinically important difference (MCID) in GI Health (5) 6 weeks Likelihood of experiencing minimal clinically important difference in GI Health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Gastroesophageal Reflux 13A (scale 8-64; with higher scores corresponding to more severe reflux)
Trial Locations
- Locations (1)
Radicle Science, Inc
🇺🇸Del Mar, California, United States