Radicle GI Health DBG: A Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes

NCT07318077 | Recruiting

• 1 other identifier: RADX_P_2407_DBG
• Study Type: interventional
• Target: 825
• Locations: 1 country
• Sites: 1

Brief Summary

Radicle GI Health DBG: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI health and related health outcomes.

Conditions

Belly Pain; GI Health

Outcome Measures

Primary Outcomes (1)

• Change in Belly Pain

  Change in Belly Pain: Difference between rates of change over time in belly pain score as assessed by PROMIS Belly Pain 5A (scale 2-25; where the higher scores correspond to worse belly pain)

  7 weeks

Secondary Outcomes (3)

• Change in Gas and Bloating

  7 weeks

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

  7 weeks

• Change in mood (emotional distress-depression)

  7 weeks

Other Outcomes (11)

• Minimal clinically important difference (MCID) in Belly Pain

  7 weeks

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

  7 weeks

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

  7 weeks

Study Arms (3)

GI Health Product Placebo Control

PLACEBO COMPARATOR

GI Health Product Placebo Control

Dietary Supplement: GI Health Product Placebo Control

GI Health Active Product 2

EXPERIMENTAL

GI Health Active Product 2

Dietary Supplement: GI Health Active Product 2

GI Health Active Product 1

EXPERIMENTAL

GI Health Active Product 1

Dietary Supplement: GI Health Active Product 1

Interventions

GI Health Product Placebo Control DIETARY_SUPPLEMENT

Participants will use their GI Health Product Placebo Control as directed for a period of 6 weeks

GI Health Product Placebo Control

GI Health Active Product 1 DIETARY_SUPPLEMENT

Participants will use their GI Health Active Product 1 as directed for a period of 6 weeks

GI Health Active Product 1

GI Health Active Product 2 DIETARY_SUPPLEMENT

Participants will use their GI Health Active Product 2 as directed for a period of 6 weeks

GI Health Active Product 2

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 surveys (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
• Unable to verify their identity during consent using Veriff
• 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 approx. 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
• Lack of reliable daily access to the internet

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science Inc.

Del Mar, California, 92014, United States

RECRUITING

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

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be stratified based on their assigned sex at birth and health outcome score during enrollment, then randomized to one of the study arms. Each participant will have an equal chance of being assigned to any study arm.

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start: January 6, 2026
• Primary Completion (Estimated): January 13, 2027
• Study Completion (Estimated): January 13, 2027
• Last Updated: January 23, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)