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Study of a Ready-to-Mix Beverage for GI Health and Wellness

This study is looking at a ready-to-mix beverage containing protein, fiber, and electrolytes. We want to understand how people use this product, how they like it, and any side effects it might have. We'll also see how it affects your health, especially your gut health, through surveys. You might be able to join if you are between 21 and 75 years old, live in the United States, and have a chance to improve your main health concern by at least 30%. The main way we'll measure success is by tracking changes in constipation using a specific survey (PROMIS Constipation 9A) over four weeks. The study is currently unclear about its recruitment status.

Study design
This is an open-label study, meaning both you and the researchers will know what intervention you are receiving. It plans to enroll 133 participants.
What's involved
You would consume the ready-to-mix beverage as much as you like over a 4-week period. You will complete surveys at the start and each week for four weeks.
Compensation
Not stated in the trial record.
Follow-up
Your constipation levels will be measured at baseline and weekly for four weeks during the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07563855

An Open Label Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes

Completed
NAAges 21–75Interventional
PepsiCo Global R&D
~133 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:A ready-to-mix beverage containing protein, fiber, and electrolytes

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PROMIS Constipation 9A
Measured over At baseline and weeks 1-4 of the intervention

Conditions

Health
Wellness
Quality of Life

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Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Virtual study. Managed by Radicle Science Inc.

    Del Mar, Californiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Susan Hewlings, PhD · PRINCIPAL_INVESTIGATOR · Radicle Science Inc.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • PROMIS Constipation 9AAt baseline and weeks 1-4 of the intervention

    A patient reported outcome measure designed to assess frequency, severity, impact, and discomfort cause by gastrointestinal constipation symptoms over 7 days. The scale consists of 9 items, scored 1 to 5, with 1 being associated with a better outcome and 5 being associated with a worse outcome.