Ready-to-mix protein, fiber, and electrolyte drink for gut health and wellbeing
An Open Label Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes
This test tries a ready-to-mix protein, fiber, and electrolyte beverage to see if it improves gut health and related outcomes in U.S. adults who are either taking GLP-1 medications or trying to lose weight.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 133 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | PepsiCo Global R&D Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Del Mar, California) |
| Trial ID | NCT07563855 on ClinicalTrials.gov |
What this trial studies
This open-label, direct-to-consumer interventional study asks U.S. adults aged 21–75 to take a ready-to-mix beverage containing protein, fiber, and electrolytes every day for four weeks. Participants complete electronic surveys about symptoms, product use, and acceptability and provide stool and blood biomarker samples at baseline and at the end of the study. The study specifically enrolls people on a stable GLP-1 for at least three months or people trying to lose weight who have not used GLP-1 in the last six months. The aim is to capture participant experience, side effects, self-reported outcomes, and changes in selected biomarkers.
Who should consider this trial
Good fit: U.S. residents aged 21–75 who are willing to take the product daily for four weeks, complete electronic surveys, provide baseline and end-of-study blood and stool samples, and are either on a stable GLP-1 for ≥3 months or trying to lose weight without recent GLP-1 use.
Not a fit: People who are pregnant, breastfeeding, planning to start or stop GLP-1 medications during the study, living outside the U.S., or unwilling/unable to provide samples or a valid U.S. shipping address and mobile phone may not benefit or be eligible.
Why it matters
Potential benefit: If successful, the product could reduce GI symptoms, improve gut-related biomarkers, and support weight-management or wellbeing for some adults.
How similar studies have performed: Previous nutrition trials have shown that protein- and fiber-containing beverages can improve satiety, bowel habits, and some gut biomarkers, but this exact product formulation and direct-to-consumer approach has limited prior testing.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Del Mar, California
- Virtual study. Managed by Radicle Science Inc. — Del Mar, California, United States (Recruiting)
Study contacts
- Principal investigator: Susan Hewlings, PhD — Radicle Science Inc.
- Study coordinator: Susan Hewings, PhD
- Email: help@radiclescience.com
- Phone: 760-281-3898
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.