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NCT07744360

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

Sponsor: Olipop, PBC

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-02-10

Completion Date

2026-06-04

Last Updated

2026-08-04

Healthy Volunteers

Yes

Conditions

GI Symptoms

Interventions

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).

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

Locations (1)

People Science

Los Angeles, California, United States