An Open Label Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes

NCT07563855 | Recruiting

• 1 other identifier: PEP-2602
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to:

1. 1.Understand the participant experience using a health and wellness product and effects of the study product on GLP-1 users and those trying to lose weight
2. 2.Understand how participants may use and accept a health and wellness product
3. 3.Understand the side effects of a health and wellness product
4. 4.Evaluate the quality and effects of a health and wellness product on participant health through self-reported measures (electronic surveys) and biomarker collections.

Conditions

Health; Wellness; Quality of Life

Keywords

product; beverage; protein; fiber; electrolytes; hydration; satiety; digestion; gastrointestinal; constipation; belly pain; GLP-1; weight; attitudes; behaviors

Outcome Measures

Primary Outcomes (1)

• PROMIS Constipation 9A

  A patient reported outcome measure designed to assess frequency, severity, impact, and discomfort cause by gastrointestinal constipation symptoms over 7 days. The scale consists of 9 items, scored 1 to 5, with 1 being associated with a better outcome and 5 being associated with a worse outcome.

  At baseline and weeks 1-4 of the intervention

Secondary Outcomes (5)

• Digestion-associated Quality of Life Questionnaire

  At baseline and weeks 1-4 of the intervention

• PROMIS Belly Pain 5A

  At baseline and weeks 1-4 of the intervention

• Satiety Survey

  At baseline and weeks 1-4 of the intervention

• Self-Reported Weight

  At baseline and weeks 1-4 of intervention

• 24 Hour Recall Food Diary

  At baseline and upon completion of the 4 week intervention

Other Outcomes (25)

• Adverse Events

  From enrollment through completion of the study, average 5 weeks.

• Evaluation of an at-home Tiny Health Stool kit

  At baseline and upon completion of the 4 week intervention

• Ferritin

  At baseline and upon completion of the 4 week intervention

Study Arms (1)

GLP-1 Users and Non-users

EXPERIMENTAL

Participants currently taking a GLP-1 for 3 months or longer, or wishing to lose weight, but not currently on a GLP-1

Dietary Supplement: A ready-to-mix beverage containing protein, fiber, and electrolytes

Interventions

A ready-to-mix beverage containing protein, fiber, and electrolytes DIETARY_SUPPLEMENT

Subjects will consume the ready-to-mix beverage ad-libitum over the 4-week study period.

GLP-1 Users and Non-users

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults, at least 21-75 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
• One of the following:
• Currently taking a GLP-1 for at least 3 months with no plans to stop or switch current GLP-1
• Expressing the interest to lose weight, but not currently taking a GLP-1 in the last 6 months and with no plans to start taking a GLP-1
• Must be willing to complete a biomarker collection (stool and blood) at 2 timepoints during the study (baseline and end of study)
• Expresses a willingness to take the study product everyday for 4 weeks

You may not qualify if:

• 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 enrollment, current or within in the past 30 days, in another clinical trial
• 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 to treat Type 1 or Type 2 diabetes , oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products
• Reports current use, or use within the past 30 days, of whey protein and/or similar product(s) to the study product that may limit the effects of the study products and/or pose a safety risk
• Reports taking an antibiotic or probiotic in the last 4 weeks
• Lack of reliable daily access to the internet

Sponsors & Collaborators

• PepsiCo Global R&D: lead
• Radicle Science Inc.: collaborator

Study Sites (1)

Virtual study. Managed by Radicle Science Inc.

Del Mar, California, 90214, United States

RECRUITING

MeSH Terms

Conditions

Constipation; Body Weight; Behavior

Interventions

Dietary Fiber; Electrolytes

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Inorganic Chemicals

Study Officials

• Susan Hewlings, PhD

  Radicle Science Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Hewings, PhD

CONTACT

760-281-3898; help@radiclescience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 4, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)