NCT07563855 An Open Label Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes
| NCT ID | NCT07563855 |
| Status | Recruiting |
| Phase | — |
| Sponsor | PepsiCo Global R&D |
| Condition | Health |
| Study Type | INTERVENTIONAL |
| Enrollment | 133 participants |
| Start Date | 2026-04 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 133 participants in total. It began in 2026-04 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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
Contact & Investigator
Susan Hewlings, PhD
PRINCIPAL INVESTIGATOR
Radicle Science Inc.
Frequently Asked Questions
Who can join the NCT07563855 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 75 Years, studying Health. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07563855 currently recruiting?
Yes, NCT07563855 is actively recruiting participants. Contact the research team at help@radiclescience.com for enrollment information.
Where is the NCT07563855 trial being conducted?
This trial is being conducted at Del Mar, United States.
Who is sponsoring the NCT07563855 clinical trial?
NCT07563855 is sponsored by PepsiCo Global R&D. The principal investigator is Susan Hewlings, PhD at Radicle Science Inc.. The trial plans to enroll 133 participants.