Recruiting

Health & Wellness Products

Sponsor:

Radicle Science

Code:

NCT07653776

Conditions

Digestion-associated Quality of Life

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

Placebo GI Health Control

Active GI Health Product 1

Study Details

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.

Conditions

Digestion-associated Quality of Life

Study ID

NCT07653776

Start date

Jun 15, 2026

Status verified date

Aug, 2026

Completion date

Jun 12, 2027

Anticipated

Primary completion date

Jun 12, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

550 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Active GI Health Product 1

Active GI Health Product 1

placebo comparator: Placebo GI Health Control

Placebo GI Health Control

Interventions

Placebo GI Health Control

Participants will use their Placebo GI Health Control as directed for a period of 8 weeks

Active GI Health Product 1

Participants will use their Active GI Health Product 1 as directed for a period of 8 weeks"

Primary outcome measure

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

Central Contacts and Locations

Locations

Radicle Science Inc.

Recruiting

Del Mar, California, United States, 92014

Contacts

More Information

Sponsor

Radicle Science

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Radicle Science on 2026-08-20.