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

Radicle GI Health DBG™: A Randomized, Double-Blind, Placebo Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes

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.

Study Overview

• Status: Recruiting
• Conditions: GI Health; Belly Pain
• Intervention / Treatment: Dietary supplement: GI Health Product Placebo Control; Dietary supplement: GI Health Active Product 2; Dietary supplement: GI Health Active Product 1

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, and (2) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. 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 6 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.

• Study Type: Interventional
• Enrollment (Estimated): 825
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Manager; Phone Number: 858-779-0086; Email: studymgmt@radiclescience.com
• Study Contact Backup: Name: Susan Hewlings; Phone Number: 760-281-3898; Email: susan.hewlings@radiclescience.com

Study Locations

• United States
  • California
    • Del Mar, California, United States, 92014
      • Recruiting
      • Radicle Science Inc.
      • Contact: Study Manager; Phone Number: 760-281-3898; Email: studymgmt@radiclescience.com
      • Contact: Megan Moseley; Email: megan@radiclescience.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 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

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: GI Health Product Placebo Control	Dietary supplement: GI Health Product Placebo Control; Participants will use their GI Health Product Placebo Control as directed for a period of 6 weeks
Experimental: GI Health Active Product 2	Dietary supplement: GI Health Active Product 2; Participants will use their GI Health Active Product 2 as directed for a period of 6 weeks
Experimental: GI Health Active Product 1	Dietary supplement: GI Health Active Product 1; Participants will use their GI Health Active Product 1 as directed for a period of 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mood (emotional distress-depression)	Change in mood (emotional distress-depression): Difference in rates of change over time in emotional distress score as assessed by PROMIS Emotional Distress- Depression 8A (scale 8-40; with higher scores corresponding to greater levels of emotional distress)	7 weeks
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)	7 weeks
Change in Gas and Bloating	Change in Gas and Bloating: Difference between rates of change over time in gas and bloating score as assessed by PROMIS Gas and Bloating 13A (scale 3-59; where the higher scores correspond to worse gas and bloating)	7 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in feelings of anxiety	Change in feelings of anxiety: Difference between rates of change over time in feelings of anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)	7 weeks
Minimal clinically important difference (MCID) in feelings of anxiety	Minimal clinically important difference (MCID) in feelings of anxiety: Likelihood of experiencing minimal clinically important difference in feelings of anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)	7 weeks
Minimal clinically important difference (MCID) in mood (emotional distress-depression)	Minimal clinically important difference (MCID) in mood (emotional distress-depression): Likelihood of experiencing minimal clinically important difference in mood score as assessed by PROMIS Emotional Distress- Depression 8A (scale 8-40; with higher scores corresponding to greater levels of emotional distress)	7 weeks
Minimal clinically important difference (MCID) in GI-related QOL	Minimal clinically important difference (MCID) in GI-related QOL: Likelihood of experiencing minimal clinically important difference in GI-related QOL score as assessed by Digestion-associated Quality of Life Questionnaire (scale 0-9; where the higher scores correspond to worse GI-related QOL)	7 weeks
Minimal clinically important difference (MCID) in Belly Pain	Minimal clinically important difference (MCID) in Belly Pain: Likelihood of experiencing minimal clinically important difference in belly pain as assessed by PROMIS Belly Pain 5A (scale 2-25; where the higher scores correspond to worse belly pain)	7 weeks
Minimal clinically important difference (MCID) in Gas and Bloating	Minimal clinically important difference (MCID) in Gas and Bloating: Likelihood of experiencing minimal clinically important difference in gas and bloating, as measured by PROMIS Gas and Bloating 13A (scale 3-59; where the higher scores correspond to worse gas and bloating)	7 weeks
Change in Diarrhea	Change in Diarrhea: Difference between rates of change over time in diarrhea score as assessed by PROMIS Diarrhea 6A (scale 2-30; where the higher scores correspond to worse diarrhea)	7 weeks
Minimal clinically important difference (MCID) in Diarrhea	Minimal clinically important difference (MCID) in Diarrhea: Likelihood of experiencing minimal clinically important difference in diarrhea, as measured by PROMIS Diarrhea 6A scale (2-30; where the higher scores correspond to worse diarrhea)	7 weeks
Change in Reflux	Change in Reflux: Difference in rates of change over time in reflux score as assessed by PROMIS Gastrointestinal Gastroesophageal Reflux 13A (scale 8-64; with higher scores corresponding to more severe reflux)	7 weeks
Minimal clinically important difference (MCID) in reflux	Minimal clinically important difference (MCID) in reflux: Likelihood of experiencing minimal clinically important difference in reflux as assessed by PROMIS Gastrointestinal Gastroesophageal Reflux 13A (scale 8-64; with higher scores corresponding to more severe reflux)	7 weeks
Change in nausea and vomiting	Change in nausea and vomiting: Difference in rates of change over time in nausea and vomiting score as assessed by PROMIS Gastrointestinal Nausea and Vomiting 4A (scale 3-20; with higher scores corresponding to more severe nausea and vomiting)	7 weeks

Collaborators and Investigators

• Sponsor: Radicle Science
• Investigators: Principal Investigator: Susan Hewlings, Radicle Science

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2026
• Primary Completion (Estimated): January 13, 2027
• Study Completion (Estimated): January 13, 2027

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: December 19, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: RADX_P_2407_DBG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared with researchers outside of Radicle Collaborators on this study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No