Digestion-associated Quality of Life
Conditions
Brief summary
Radicle GI Health RAA: A randomized, double-blind, placebo- controlled direct-to-consumer study assessing the impact of health and wellness products on gastrointestinal-related quality of life 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) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, (2) currently experience persistent gas, bloating, indigestion, and/or irregular bowel movements for 3 months or more, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study. 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 9 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
Interventions
DIETARY_SUPPLEMENTPlacebo GI Health Control
Participants will use their Placebo GI Health Control as directed for a period of 8 weeks
DIETARY_SUPPLEMENTActive GI Health Product 1
Participants will use their Active GI Health Product 1 as directed for a period of 8 weeks"
Sponsors
Radicle Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Eligible participants must complete all enrollment steps to be stratified. Participants will be stratified based on their sex assignment at birth and health outcome score during enrollment, then randomized to one of the study groups sequentially based on all stratification measures collectively to ensure equal distribution to each study product group. Participants will be provided the study product and an insert with additional information on product usage and study procedures.
Eligibility
Sex/Gender
ALL
Age
21 Years to 105 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion Participants must meet all the following criteria: * 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 PROs (male vs female) employed, when needed * Resides in the United States * Has the opportunity for at least 30% 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 Exclusion Individuals who report any of the following during screening may be excluded from participation: * 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 and/or use of investigational drugs * Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) * Unable to read and understand English at a 7th grade level * 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 Class III 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, MAOIs, 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 products and/or pose a safety risk * Reports illicit drug use * Reports a cancer diagnosis within the last 2 years * Reports current use of weight loss or appetite modifying medications or supplements (including GLP-1 receptor agonists) * Reports current use of prescription stimulant, sedative, sleep, or other central nervous system-active medications * Reports current use of prebiotics/probiotics, multivitamin supplements, gut health supplements, synbiotics, greens powders * Lack of reliable daily access to the internet * Participants residing in the states of New York, New Jersey, or Rhode Island are eligible to enroll in the main study and will complete all primary study activities. However, these participants are not eligible to participate in the biomarker sub-study. This restriction is due to state regulatory requirements governing direct-to-consumer at-home laboratory specimen collection and processing that cannot be accommodated within the fully decentralized design of the sub-study. No alternative collection pathway is available under the current protocol. To ensure compliance, state-of-residence logic is built into the enrollment platform. Participants who indicate a residential address in New York, New Jersey, or Rhode Island will not be presented with the biomarker sub-study consent or any associated study materials. This automated screening ensures that ineligible participants are not inadvertently enrolled in the sub-study. These participants will otherwise proceed through full main study enrollment and participation without interruption.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in GI-related Quality of Life (QOL) | 9 weeks | Change in GI-related Quality of Life (QOL): Difference between rates of change over time in GI-related QOL as assessed by Digestion-associated Quality of Life Questionnaire (scale 0-9; where the higher scores correspond to worse GI-related quality of life) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gas and Bloating | 9 weeks | Change in Gas and Bloating: Difference between rates of change over time in gas and bloating score as assessed by PROMIS Gas and Bloating 13A (scale 3-59; where the higher scores correspond to worse gas and bloating) |
| Change in fatigue | 9 weeks | Change in fatigue: Difference in rates of change over time in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue) |
| Change in feelings of anxiety | 9 weeks | Change in feelings of anxiety: Difference between rates of change over time in feelings of anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety) |
Countries
United States
Contacts
CONTACTStudy Manager
CONTACTSusan Hewlings
PRINCIPAL_INVESTIGATORSusan Hewlings
Radicle Science
Outcome results
None listed