Actively Recruiting
An Open Label Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes
Led by PepsiCo Global R&D · Updated on 2026-05-04
133
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
P
PepsiCo Global R&D
Lead Sponsor
R
Radicle Science Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a health and wellness product on gastrointestinal health and related outcomes in adults aged 21 to 75. This study aims to understand user experiences, side effects, product acceptance, and health impacts in people currently using GLP-1 medications for at least 3 months or those interested in losing weight but not on GLP-1 therapy. The study is sponsored by PepsiCo Global R&D and uses self-reported measures and biomarker collections to assess outcomes. Participants will consume a ready-to-mix beverage containing protein, fiber, and electrolytes freely over a 4-week period. The study includes adults who either have been taking GLP-1 for 3 months or longer without plans to stop or switch, or those interested in weight loss but not currently using GLP-1 and with no plans to start. Biomarker collections of stool and blood samples will occur at the start and end of the intervention period. During the study, participants will complete electronic surveys measuring constipation, belly pain, digestion quality of life, satiety, and self-reported weight at baseline and weekly during the 4 weeks. They will also keep a 24-hour food diary at the beginning and end of the study. Researchers will monitor participant health and product effects through these assessments and biomarker samples. The study is open label with no blinding, and participants must have reliable internet access to complete electronic surveys and biomarker collections. Total participation lasts for the 4-week intervention.
CONDITIONS
Brief Title
An Open Label Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 21 to 75 years at the time of electronic consent
- Inclusive of all ethnicities, races, and gender identities
- Assigned sex at birth determines sex-specific recruitment and surveys when needed
- Resides in the United States
- Has opportunity for at least 30% improvement in their primary health outcome
- Currently taking a GLP-1 medication for at least 3 months with no plans to stop or switch, OR interested in losing weight but not taken GLP-1 in the last 6 months and no plans to start
- Willing to complete biomarker collections (stool and blood) at baseline and end of study
- Willing to take the study product daily for 4 weeks
You will not qualify if you...
- Pregnant, trying to become pregnant, or breastfeeding
- Unable to provide a valid US shipping address and mobile phone number
- Currently enrolled in another clinical trial or enrolled within the past 30 days
- Heavy drinking (3 or more alcoholic beverages per day)
- Unable to read and understand English at a 7th grade level
- Recent major illness or surgery within last 3 months posing significant safety risk
- Diagnosed with cardiac dysfunction, liver or kidney disease posing contraindication or safety risk with 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
- Taking medications with moderate or severe interaction risks with study product ingredients (e.g., anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure meds, corticosteroids above 5 mg/day, diabetic medications, oral anti-infectives, antipsychotics, MAOIs, thyroid products)
- Current or recent (past 30 days) use of whey protein or similar products that could limit study effects or pose safety risks
- Taken antibiotics or probiotics in the last 4 weeks
- Lack of reliable daily internet access
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 weeks
Participants consume a ready-to-mix beverage containing protein, fiber, and electrolytes daily over the 4-week study period while their GI health and related outcomes are assessed.
1 baseline visit and weekly visits for 4 weeks
Trial Site Locations
Total: 1 location
1
Virtual study. Managed by Radicle Science Inc.
Del Mar, California, United States, 90214
Actively Recruiting
Research Team
S
Susan Hewings, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here