Radicle GI Health: A Study of Health and Wellness Products on GI Health and Other Health Outcomes
- Conditions
- GI DisordersDigestionAbdominal Pain
- Interventions
- Dietary Supplement: Radicle GI Health Placebo Control Form 2Dietary Supplement: Radicle GI Health Active Study Product 2.1 UsageDietary Supplement: Radicle GI Health Active Study Product 2.2 UsageDietary Supplement: Radicle GI Health Placebo Control Form 3Dietary Supplement: Radicle GI Health Placebo Control Form 1Dietary Supplement: Radicle GI Health Active Study Product 1.1 UsageDietary Supplement: Radicle GI Health Active Study Product 3.1 Usage
- Registration Number
- NCT06009614
- Lead Sponsor
- Radicle Science
- Brief Summary
A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on gastrointestinal (GI) health and other health outcomes
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2180
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Control 2 Radicle GI Health Placebo Control Form 2 GI Health Product Form 2 - control Active Product 2.1 Radicle GI Health Active Study Product 2.1 Usage GI Health Product Form 2 - active product 1 Active Product 2.2 Radicle GI Health Active Study Product 2.2 Usage GI Health Product Form 2 - active product 2 Placebo Control 3 Radicle GI Health Placebo Control Form 3 GI Health Product Form 3 - control Placebo Control 1 Radicle GI Health Placebo Control Form 1 GI Health Product Form 1 - control Active Product 1.1 Radicle GI Health Active Study Product 1.1 Usage GI Health Product Form 1 - active product 1 Active Product 3.1 Radicle GI Health Active Study Product 3.1 Usage GI Health Product Form 3 - active product 1
- Primary Outcome Measures
Name Time Method Change in GI (Gastrointestinal) - 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)
- Secondary Outcome Measures
Name Time Method Change in gas/bloating 6 weeks 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)
Minimal clinically important difference (MCID) in gas/bloating 6 weeks Likelihood of experiencing MCID in gas/bloating PROMIS GI Gas and Bloating 13A
Minimal clinically important difference (MCID) in GI-related QOL 6 weeks Likelihood of experiencing MCID in GI-related QOL as assessed by Digestion-associated QOL Questionnaire (DGLQ)
Minimal clinically important difference (MCID) in abdominal pain 6 weeks Likelihood of experiencing MCID in abdominal pain as assessed by PROMIS Belly Pain 5A
Change in abdominal pain 6 weeks 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)
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)
Trial Locations
- Locations (1)
Radicle Science, Inc
🇺🇸Del Mar, California, United States