Radicle GI Health RDH™: A Study Assessing the Impact of Health and Wellness Products on Gastrointestinal (GI) Health and Related Health Outcomes

NCT07230821 | Active Not Recruiting

• 1 other identifier: RADX_P_2407_RDH
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Gastrointestinal (GI) Health and Related Health Outcomes

Conditions

Gas and Bloating; Diarrhea; Constipation

Outcome Measures

Primary Outcomes (1)

• Lower GI Collective

  Difference between rates of change over time in lower GI score as assessed by a composite of PROMIS Gas and Bloating 13A, Diarrhea 6A, and Constipation 9A (scale 10-134; where the higher scores correspond to worse lower GI health)

  7 weeks

Secondary Outcomes (3)

• Change in feelings of anxiety

  7 weeks

• Change in mood (emotional distress-depression)

  7 weeks

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

  7 weeks

Other Outcomes (4)

• Minimal clinically important difference (MCID) in lower GI health

  7 weeks

• Minimal clinically important difference (MCID) in feelings of anxiety

  7 weeks

• Minimal clinically important difference (MCID) in mood (emotional distress-depression)

  7 weeks

Study Arms (2)

Active Product 1

EXPERIMENTAL

GI Health Active Product 1

Dietary Supplement: GI Health Active Product 1

Placebo Control

PLACEBO COMPARATOR

GI Health Product Placebo Control

Dietary Supplement: GI Health Product Placebo Control

Interventions

GI Health Active Product 1 DIETARY_SUPPLEMENT

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

Active Product 1

GI Health Product Placebo Control DIETARY_SUPPLEMENT

Participants will use their \[Product Name\] Control as directed for a period of 6 weeks

Placebo Control

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
• 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
• 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

Location

Related Links

• Related Info

MeSH Terms

Conditions

Mucopolysaccharidosis IV; Diarrhea; Constipation

Condition Hierarchy (Ancestors)

Mucopolysaccharidoses; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Susan Hewlings

  Radicle Science

  PRINCIPAL INVESTIGATOR

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: November 13, 2025
• First Posted: November 17, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): December 11, 2026
• Study Completion (Estimated): December 11, 2026
• Last Updated: April 21, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)