NCT07563855NARecruitingAccepts Healthy Volunteers
An Open Label Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes
PepsiCo Global R&D
Start Date
4/1/2026
Completion Date
8/1/2026
Summary
The purpose of this study is to: 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. Understand how participants may use and accept a health and wellness product 3. Understand the side effects of a health and wellness product 4. Evaluate the quality and effects of a health and wellness product on participant health through self-reported measures (electronic surveys) and biomarker collections.
Eligibility Criteria
Age Range: 21 years to 75 years
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
Interventions
DIETARY_SUPPLEMENT
A ready-to-mix beverage containing protein, fiber, and electrolytes
Conditions
HealthWellnessQuality of Life
Locations
Virtual study. Managed by Radicle Science Inc.
Del Mar, California 90214
United States