GI SymptomsNCT07744360
A Pilot Study Evaluating the Impact of a Prebiotic Soda on Gastrointestinal Symptoms in Users of GLP-1 Agonists
A study testing Prebiotic Soda in people with GI Symptoms, run by Olipop, PBC at 1 site in United States.
Trial summary
The main objective of this study is to assess the impact of drinking a prebiotic soda on the gastrointestinal (GI) symptoms associated with the use of GLP-1 receptor agonists compared to usual fluid intake. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- GI Symptoms
- What is being tested?
- Prebiotic Soda
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2026to 4 Jun 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 - 65 years old
- Currently on prescribed GLP-1 Agonist therapy (semaglutide and/or tirzepatide) for weight management for at least 1 week to 1 month AND experiencing at least one GI side effect (i.e., nausea, diarrhea, constipation, dyspepsia, abdominal pain)
- Not taking any prescription medications for side effect management
- Not taking fiber supplements to manage constipation
- Confirmation of planning to be on GLP-1 therapy for at least 3 more months
- Open to consuming a carbonated soda beverage
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- In good general health at the time of screening
- Able to read and understand English
- Able to read, understand, and provide informed consent
- Able to use a personal smartphone device and download Chloe by People Science
- Able to receive shipment of the product at an address within the United States (No PO boxes, APO military PO boxes, Hawaii or Alaska addresses)
- Able to complete study assessments over the course of up to 13 weeks
- No known diagnosis of IBS or IBD
Who cannot join
- Do not have a personal smartphone, internet access, or unwilling to download Chloe
- Received any investigational therapies or treatments within 30 days prior to randomization.
- Have gastrointestinal illnesses
- Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder
- Currently pregnant, planning to become pregnant in the next 4 months, or breastfeeding
- Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes
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- Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the study or impact the study outcomes
- Known hypersensitivity or previous allergic reaction to OLIPOP prebiotic soda or any prebiotic beverage
- Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator
- Current consumer of prebiotic sodas
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized Controlled Pilot Study Evaluating the Impact of a Prebiotic Soda on Gastrointestinal Symptoms in Users of GLP-1 Agonists
The main objective of this study is to assess the impact of drinking a prebiotic soda on the gastrointestinal (GI) symptoms associated with the use of GLP-1 receptor agonists compared to usual fluid intake.
Read the detailed description
The primary aim of this study is to evaluate the effects of including a daily prebiotic soda (i.e., OLIPOP) over a 4-week period on gastrointestinal (GI) symptoms in adults who recently initiated GLP-1 receptor agonist (GLP-1 RA).
The study design is exploratory in nature and is set up as a real-world at-home, randomized two-arm study. Participants (n=80) will have initiated GLP-1 RA therapy for weight management at least 1 week but no greater than 4 weeks prior to study enrollment and have at least one reported GI symptom at enrollment. Participants will be randomized to either a control group (continuing to drink their usual fluid intake) or a behavioral intervention group (OLIPOP prebiotic soda,1 can (12 fl oz., 6 g dietary fiber)/day, with the option to consume 2 cans (24 fl oz., 12 g dietary fiber)/day, if desired).
Secondary outcomes will include evaluating the effects of prebiotic soda consumption on additional markers of digestive health support (i.e., bowel frequency and stool consistency), health-related quality of life, body weight and BMI, habitual dietary intake, appetite, GI symptom rescue medication usage, safety profile (AE/SAE) and participant experience and satisfaction.
- Conditions
- GI Symptoms
- Being tested
- Prebiotic Soda
- Keywords
- GLP-1 agonist, GI Symptoms, Prebiotic Fiber, Digestive Health Support, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic SodaOther
Participants will be randomized to consume at least one serving (12 fl oz) of prebiotic soda (6 g dietary fiber/serving) per day, with the option to consume up to two servings (24 fl oz., 12 g dietary fiber/day).
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic Soda | Experimental | Participants will be randomized to consume prebiotic soda intervention Receives: Other: Prebiotic Soda |
| Control (Usual Fluid Intake) | No intervention | Participants will be randomized to continue consumption of their typical daily fluid intake. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the impact of a prebiotic soda on gastrointestinal (GI) symptoms in users of GLP-1 agonists
The Gastrointestinal Symptom Rating Scale (GSRS)
Measured: Baseline, week 1, week 2, and week 4
Secondary outcomes (8)
Evaluate impact of a prebiotic soda on health-related quality of life
36-item Short Form Health Survey (SF-36)
Measured: Baseline and week 4
Evaluate the impact of a prebiotic soda on stool characteristics
Modified Bristol Stool Scale (mBSS)
Measured: Completed daily from baseline to week 4
Evaluate the impact of prebiotic soda on habitual dietary intake
Food Frequency Questionnaire
Measured: Baseline, week 2, and week 4
Evaluate the impact of a prebiotic soda on appetite
Appetite Survey
Measured: Baseline, week 1, week 2, week 3, and week 4
Evaluate the impact of a prebiotic soda on body weight and BMI
Body Weight and Body Mass Index
Measured: Baseline and week 4
Evaluate the impact of a prebiotic soda on GI side effect medication use
Assessment on the type, frequency and dose of rescue medications used for GI side effects reported over the study
Measured: Daily throughout study (baseline to week 4)
Evaluate the impact of a prebiotic soda on AEs and SAEs.
Assessment of the number, frequency, and severity of adverse events (AEs), serious adverse events (SAEs) and AE withdrawals reported over the product use period.
Measured: Weekly throughout study period (Week 1 through Week 4)
Evaluate the participant beverage satisfaction and experience of a prebiotic soda
Experience/Feedback Survey
Measured: End of Study (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start10 Feb 2026
- Primary completion4 May 2026
- Study completion4 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GI SymptomsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olipop, PBC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744360
- Sponsor's protocol ID
- PS32
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 4 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 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized Controlled Pilot Study Evaluating the Impact of a Prebiotic Soda on Gastrointestinal Symptoms in Users of GLP-1 Agonists
- ClinicalTrials.gov ID
- NCT07744360
- Acronym / sponsor ID
- PS32
- Conditions
- GI Symptoms
- Keywords
- GLP-1 agonist, GI Symptoms, Prebiotic Fiber, Digestive Health Support, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Olipop, PBCIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 4 Jun 2026 (actual)
- First posted
- 4 Aug 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 main objective of this study is to assess the impact of drinking a prebiotic soda on the gastrointestinal (GI) symptoms associated with the use of GLP-1 receptor agonists compared to usual fluid intake.
Detailed description
The primary aim of this study is to evaluate the effects of including a daily prebiotic soda (i.e., OLIPOP) over a 4-week period on gastrointestinal (GI) symptoms in adults who recently initiated GLP-1 receptor agonist (GLP-1 RA).
The study design is exploratory in nature and is set up as a real-world at-home, randomized two-arm study. Participants (n=80) will have initiated GLP-1 RA therapy for weight management at least 1 week but no greater than 4 weeks prior to study enrollment and have at least one reported GI symptom at enrollment. Participants will be randomized to either a control group (continuing to drink their usual fluid intake) or a behavioral intervention group (OLIPOP prebiotic soda,1 can (12 fl oz., 6 g dietary fiber)/day, with the option to consume 2 cans (24 fl oz., 12 g dietary fiber)/day, if desired).
Secondary outcomes will include evaluating the effects of prebiotic soda consumption on additional markers of digestive health support (i.e., bowel frequency and stool consistency), health-related quality of life, body weight and BMI, habitual dietary intake, appetite, GI symptom rescue medication usage, safety profile (AE/SAE) and participant experience and satisfaction.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prebiotic Soda | Experimental | Other: Prebiotic SodaParticipants will be randomized to consume prebiotic soda intervention |
| Control (Usual Fluid Intake) | No intervention | –Participants will be randomized to continue consumption of their typical daily fluid intake. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age between 18 - 65 years old
- Currently on prescribed GLP-1 Agonist therapy (semaglutide and/or tirzepatide) for weight management for at least 1 week to 1 month AND experiencing at least one GI side effect (i.e., nausea, diarrhea, constipation, dyspepsia, abdominal pain)
- Not taking any prescription medications for side effect management
- Not taking fiber supplements to manage constipation
- Confirmation of planning to be on GLP-1 therapy for at least 3 more months
Key exclusion criteria (10 listed)
- Do not have a personal smartphone, internet access, or unwilling to download Chloe
- Received any investigational therapies or treatments within 30 days prior to randomization.
- Have gastrointestinal illnesses
- Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder
- Currently pregnant, planning to become pregnant in the next 4 months, or breastfeeding
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 |
|---|---|---|
| Prebiotic SodaParticipants will be randomized to consume at least one serving (12 fl oz) of prebiotic soda (6 g dietary fiber/serving) per day, with the option to consume up to two servings (24 fl oz., 12 g dietary fiber/day). | Other | Prebiotic Soda |
Primary outcome
Evaluate the impact of a prebiotic soda on gastrointestinal (GI) symptoms in users of GLP-1 agonists
Time frame: Baseline, week 1, week 2, and week 4
The Gastrointestinal Symptom Rating Scale (GSRS)
8 secondary outcomes
Evaluate impact of a prebiotic soda on health-related quality of life
Time frame: Baseline and week 4
Evaluate the impact of a prebiotic soda on stool characteristics
Time frame: Completed daily from baseline to week 4
Evaluate the impact of prebiotic soda on habitual dietary intake
Time frame: Baseline, week 2, and week 4
Evaluate the impact of a prebiotic soda on appetite
Time frame: Baseline, week 1, week 2, week 3, and week 4
Evaluate the impact of a prebiotic soda on body weight and BMI
Time frame: Baseline and week 4
Evaluate the impact of a prebiotic soda on GI side effect medication use
Time frame: Daily throughout study (baseline to week 4)
Evaluate the impact of a prebiotic soda on AEs and SAEs.
Time frame: Weekly throughout study period (Week 1 through Week 4)
Evaluate the participant beverage satisfaction and experience of a prebiotic soda
Time frame: End of Study (week 4)
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 4 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic Soda in people with GI Symptoms, run by Olipop, PBC 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 13 inclusion and 10 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 4 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?
Evaluate the impact of a prebiotic soda on gastrointestinal (GI) symptoms in users of GLP-1 agonists (time frame: Baseline, week 1, week 2, and week 4). 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 4 Aug 2026.