HealthNCT07563855
An Open Label Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes
A study testing A ready-to-mix beverage containing protein, fiber, and electrolytes in people with Health and Wellness, run by PepsiCo Global R&D at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Health, Wellness, Quality of Life
- What is being tested?
- A ready-to-mix beverage containing protein, fiber, and electrolytes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2026to 7 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virtual study. Managed by Radicle Science Inc.
Del Mar, California, 90214
About this study
The purpose of this study is to:
- 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
- Understand how participants may use and accept a health and wellness product
- Understand the side effects of a health and wellness product
- Evaluate the quality and effects of a health and wellness product on participant health through self-reported measures (electronic surveys) and biomarker collections.
- Conditions
- Health, Wellness, Quality of Life
- Being tested
- A ready-to-mix beverage containing protein, fiber, and electrolytes
- Keywords
- product, beverage, protein, fiber, electrolytes, hydration, satiety, digestion, gastrointestinal, constipation, belly pain, GLP-1, weight, attitudes, behaviors
- Medical subject headings
- Constipation, Body Weight, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A ready-to-mix beverage containing protein, fiber, and electrolytesDietary supplement
Subjects will consume the ready-to-mix beverage ad-libitum over the 4-week study period.
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 Users and Non-users | Experimental | Participants currently taking a GLP-1 for 3 months or longer, or wishing to lose weight, but not currently on a GLP-1 Receives: Dietary Supplement: A ready-to-mix beverage containing protein, fiber, and electrolytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Constipation 9A
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.
Measured: At baseline and weeks 1-4 of the intervention
Secondary outcomes (5)
Digestion-associated Quality of Life Questionnaire
A validated tool designed to assess impact of gastrointestinal symptoms on the quality of life of healthy individuals over 7 days. The questionnaire consists of 9 items, scaled from Never to Always, with Never being associated with a better outcome and 1 being associated with a worse outcome.
Measured: At baseline and weeks 1-4 of the intervention
PROMIS Belly Pain 5A
A patient reported outcome measure designed to assess the severity of belly pain experienced by participants over 7 days. The scale consists of 5 items, scored 1 to 5, with 1 being associated with a worse outcome and 5 being associated with a better outcome.
Measured: At baseline and weeks 1-4 of the intervention
Satiety Survey
A 4 question survey, scaled 0 (not at all) to 10 (extremely) designed to assess satiety
Measured: At baseline and weeks 1-4 of the intervention
Self-Reported Weight
lbs
Measured: At baseline and weeks 1-4 of intervention
24 Hour Recall Food Diary
ASA24
Measured: At baseline and upon completion of the 4 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start4 May 2026
- Primary completion7 Jul 2026
- Study completion7 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Radicle Science Inc.
- Responsible party
- Sponsor
- Investigators
- Susan Hewlings, PhD, Principal investigator, Radicle Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563855
- Sponsor's protocol ID
- PEP-2602
- Status last verified
- Aug 2026
- First submitted
- 16 Apr 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes
- ClinicalTrials.gov ID
- NCT07563855
- Acronym / sponsor ID
- PEP-2602
- Conditions
- Health, Wellness, Quality of Life
- Keywords
- product, beverage, protein, fiber, electrolytes, hydration, satiety, digestion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Collaborators
- Radicle Science Inc.
- Study start
- 4 May 2026 (actual)
- Primary completion
- 7 Jul 2026 (actual)
- Study completion
- 7 Jul 2026 (actual)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to:
- 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
- Understand how participants may use and accept a health and wellness product
- Understand the side effects of a health and wellness product
- Evaluate the quality and effects of a health and wellness product on participant health through self-reported measures (electronic surveys) and biomarker collections.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GLP-1 Users and Non-users | Experimental | Dietary Supplement: A ready-to-mix beverage containing protein, fiber, and electrolytesParticipants currently taking a GLP-1 for 3 months or longer, or wishing to lose weight, but not currently on a GLP-1 |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A ready-to-mix beverage containing protein, fiber, and electrolytesSubjects will consume the ready-to-mix beverage ad-libitum over the 4-week study period. | Dietary supplement | GLP-1 Users and Non-users |
Primary outcome
PROMIS Constipation 9A
Time frame: At 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.
5 secondary outcomes
Digestion-associated Quality of Life Questionnaire
Time frame: At baseline and weeks 1-4 of the intervention
PROMIS Belly Pain 5A
Time frame: At baseline and weeks 1-4 of the intervention
Satiety Survey
Time frame: At baseline and weeks 1-4 of the intervention
Self-Reported Weight
Time frame: At baseline and weeks 1-4 of intervention
24 Hour Recall Food Diary
Time frame: At baseline and upon completion of the 4 week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Hewlings, PhD principal investigator
Radicle Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A ready-to-mix beverage containing protein, fiber, and electrolytes in people with Health and Wellness, run by PepsiCo Global R&D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Constipation 9A (time frame: At baseline and weeks 1-4 of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.