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

NCT07713810 | Not Yet Recruiting

• 1 other identifier: RADX_P_2604_VNB
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Constipation

  Change in Constipation: Difference between rates of change over time in constipation score as assessed by PROMIS Constipation 9A (scale 5-45; where the higher scores correspond to worse constipation)

  5 weeks

Secondary Outcomes (3)

• Change in Gas and Bloating

  5 weeks

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

  5 weeks

• Change in the severity of gastrointestinal symptoms

  5 weeks

Other Outcomes (8)

• Minimal clinically important difference (MCID) in Constipation

  5 weeks

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

  5 weeks

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

  5 weeks

Study Arms (2)

Active GI Health Product 1

EXPERIMENTAL

Active GI Health Product 1

Dietary Supplement: Active GI Health Product

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 product as directed for a period of 4 weeks

Placebo GI Health Control

Active GI Health Product DIETARY_SUPPLEMENT

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science Inc.

Del Mar, California, 92014-2605, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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 who complete all enrollment requirements will be stratified before randomization. Stratification will be based on three factors: sex assigned at birth (female or non-female), age (21-44, 45-64, or 65+ years), and health outcome score (categorized according to published PROMIS scoring guidelines). Participants will then be randomized sequentially within each stratum to one of the study groups to ensure balanced allocation across treatment arms across all stratification factors. Following randomization, participants will receive their assigned study product along with written instructions describing product use and study procedures.

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: July 16, 2026
• Primary Completion (Estimated): July 16, 2027
• Study Completion (Estimated): July 16, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)