Radicle GI Health RAATM: A Study Assessing the Impact of Health and Wellness Products on Gastrointestinal-Related Quality of Life and Related Health Outcomes

Official title

Radicle GI Health RAATM: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of Health and Wellness Products on Gastrointestinal-Related Quality of Life and Related Health Outcomes

Overview

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 supplement Placebo GI Health Control
  Participants will use their Placebo GI Health Control as directed for a period of 8 weeks
• Dietary supplement Active GI Health Product 1
  Participants will use their Active GI Health Product 1 as directed for a period of 8 weeks"

Primary outcome measures

• Change in GI-related Quality of Life (QOL) [Time frame: 9 weeks]

Secondary outcome measures (3)

• Change in Gas and Bloating [Time frame: 9 weeks]
• Change in fatigue [Time frame: 9 weeks]
• Change in feelings of anxiety [Time frame: 9 weeks]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Other

Study locations

United States · 1 center

• Radicle Science Inc. — Del Mar

Identifiers

NCT: NCT07653776 · RADX_P_2607_RAA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗