Recruiting

Radicle GI HealthTM

Sponsor:

Radicle Science

Code:

NCT07713810

Conditions

Constipation

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

Placebo GI Health Control

Active GI Health Product

Study Details

Brief summary:

Radicle GI HealthTM VNB: A randomized, double-blind, placebo- controlled direct-to-consumer study assessing the impact of health and wellness products on constipation and related health outcomes

Conditions

Constipation

Study ID

NCT07713810

Start date

Jul 30, 2026

Status verified date

Jul, 2026

Completion date

Jul 16, 2027

Anticipated

Primary completion date

Jul 16, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

3.1 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

3.2 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
  • 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 taking any product for acute constipation
  • Reports taking any medications containing levodopa
  • Lack of reliable daily access to the internet

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 product as directed for a period of 4 weeks

Active GI Health Product

Participants will use their Active GI Health Product as directed for a period of 4 weeks

Primary outcome measure

  • Change in Constipation [ Time Frame: 5 weeks ]

Central Contacts and Locations

Central contacts

Study Manager

858-779-0086studymgmt@radiclescience.com

Susan Hewlings

760-281-3898susan.hewlings@radiclescience.com

Locations

Radicle Science Inc.

Recruiting

Del Mar, California, United States, 92014-2605

Contacts

Study Manager

760-281-3898studymgmt@radiclescience.com

Megan Moseley

megan@radiclescience.com

More Information

Sponsor

Radicle Science

Last update posted

Aug 20, 2026

Last verified

Jul, 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.