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
17 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
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.
CONDITIONS
Official 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 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 potential for at least 30% improvement in their main health outcome
- Currently taking a GLP-1 for at least 3 months with no plans to stop or switch, or interested in losing weight without GLP-1 use in 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 drinker (3 or more alcoholic drinks per day)
- Unable to read and understand English at a 7th grade level
- Recent major illness or surgery posing significant safety risk within past 3 months
- Diagnosis of cardiac dysfunction, liver or kidney disease with known contraindication or safety risk with study product ingredients
- NYHA Class III or IV 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, including anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, grapefruit-warnings, high-dose corticosteroids, diabetic medications, oral anti-infectives, antipsychotics, MAOIs, or thyroid products
- Current or recent use (within 30 days) of whey protein or similar products that may limit study product effects or pose safety risks
- Use of 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
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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