A Pilot Study Evaluating the Impact of a Prebiotic Soda on Gastrointestinal Symptoms in Users of GLP-1 Agonists

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.

Study Overview

• Status: Completed
• Conditions: GI Symptoms
• Intervention / Treatment: Other: Prebiotic Soda

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90034
      • People Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prebiotic Soda; Participants will be randomized to consume prebiotic soda intervention	Other: Prebiotic Soda; 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).
No Intervention: Control (Usual Fluid Intake); Participants will be randomized to continue consumption of their typical daily fluid intake.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the impact of a prebiotic soda on gastrointestinal (GI) symptoms in users of GLP-1 agonists	The Gastrointestinal Symptom Rating Scale (GSRS)	Baseline, week 1, week 2, and week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate impact of a prebiotic soda on health-related quality of life	36-item Short Form Health Survey (SF-36)	Baseline and week 4
Evaluate the impact of a prebiotic soda on stool characteristics	Modified Bristol Stool Scale (mBSS)	Completed daily from baseline to week 4
Evaluate the impact of prebiotic soda on habitual dietary intake	Food Frequency Questionnaire	Baseline, week 2, and week 4
Evaluate the impact of a prebiotic soda on appetite	Appetite Survey	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	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	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.	Weekly throughout study period (Week 1 through Week 4)
Evaluate the participant beverage satisfaction and experience of a prebiotic soda	Experience/Feedback Survey	End of Study (week 4)

Collaborators and Investigators

• Sponsor: Olipop, PBC

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2026
• Primary Completion (Actual): May 4, 2026
• Study Completion (Actual): June 4, 2026

Study Registration Dates

• First Submitted: July 29, 2026
• First Submitted That Met QC Criteria: July 29, 2026
• First Posted (Actual): August 4, 2026

Study Record Updates

• Last Update Posted (Actual): August 4, 2026
• Last Update Submitted That Met QC Criteria: July 29, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; GLP-1 agonist; GI Symptoms; Prebiotic Fiber; Digestive Health Support
• Other Study ID Numbers: PS32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No