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

NCT07744360 | Completed

• 1 other identifier: PS32
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

GI Symptoms

Keywords

GLP-1 agonist; GI Symptoms; Prebiotic Fiber; Digestive Health Support; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Evaluate impact of a prebiotic soda on health-related quality of life

  Baseline and week 4

• Evaluate the impact of a prebiotic soda on stool characteristics

  Completed daily from baseline to week 4

• Evaluate the impact of prebiotic soda on habitual dietary intake

  Baseline, week 2, and week 4

• Evaluate the impact of a prebiotic soda on appetite

  Baseline, week 1, week 2, week 3, and week 4

• Evaluate the impact of a prebiotic soda on body weight and BMI

  Baseline and week 4

Study Arms (2)

Prebiotic Soda

EXPERIMENTAL

Participants will be randomized to consume prebiotic soda intervention

Other: Prebiotic Soda

Control (Usual Fluid Intake)

NO INTERVENTION

Participants will be randomized to continue consumption of their typical daily fluid intake.

Interventions

Prebiotic Soda OTHER

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).

Prebiotic Soda

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Olipop, PBC: lead

Study Sites (1)

People Science

Los Angeles, California, 90034, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start: February 10, 2026
• Primary Completion: May 4, 2026
• Study Completion: June 4, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)