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

NCT07653776 | Not Yet Recruiting

• 1 other identifier: RADX_P_2607_RAA
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in GI-related Quality of Life (QOL)

  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)

  9 weeks

Secondary Outcomes (3)

• Change in Gas and Bloating

  9 weeks

• Change in fatigue

  9 weeks

• Change in feelings of anxiety

  9 weeks

Other Outcomes (4)

• Minimal clinically important difference (MCID) in GI-related QOL

  9 weeks

• Minimal clinically important difference (MCID) in Gas and Bloating

  9 weeks

• Minimal clinically important difference (MCID) in fatigue

  9 weeks

Study Arms (2)

Active GI Health Product 1

EXPERIMENTAL

Active GI Health Product 1

Dietary Supplement: Active GI Health Product 1

Placebo GI Health Control

PLACEBO COMPARATOR

Placebo GI Health Control

Dietary Supplement: Placebo GI Health Control

Interventions

Placebo GI Health Control DIETARY_SUPPLEMENT

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

Placebo GI Health Control

Active GI Health Product 1 DIETARY_SUPPLEMENT

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

Active GI Health Product 1

Eligibility Criteria

• Age: 21 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science Inc.

Del Mar, California, 92014, United States

Location

Related Links

• Related Info

Study Officials

• Susan Hewlings

  Radicle Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Manager

CONTACT

858-779-0086; studymgmt@radiclescience.com

Susan Hewlings

CONTACT

susan.hewlings@radiclescience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: June 12, 2026
• Primary Completion (Estimated): June 12, 2027
• Study Completion (Estimated): June 12, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)