A Pilot Study Evaluating the Impact of a Prebiotic Soda on Gastrointestinal Symptoms in Users of GLP-1 Agonists | NCT07744360

NCT07744360

Overview

NCT ID: NCT07744360
Lead Sponsor: Olipop, PBCINDUSTRY
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
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
Interventions: Prebiotic Soda

Status and Timeline

Status: Completed
Last Update Posted: Aug 4, 2026Actual
Start Date: Feb 10, 2026Actual
Primary Completion Date: May 4, 2026Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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

Study Type: Interventional
Phase: Not Applicable
Enrollment: 80Actual
Primary Purpose: Basic Science
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking

Contacts and Locations

Central Contacts: No data available
Locations: People Science

Similar Studies

NCT07362563Completed

Effect of Prebiotic Sodas on Postprandial Levels of GLP-1, PYY, Transit Time and Satiety Levels: A Pilot Study

NCT07298135Recruiting

A Study to Evaluate the Effects of a Prebiotic Soda on Glycemic Control in Adults

NCT06427915Completed

Studying Glucose and Appetite Response With Alternatives to Soda Pop

NCT05418439Completed

Study to Evaluate the Efficacy of Poppi Apple Cider Vinegar Prebiotic Soda to Improve Gut Health In Participants

NCT02628652Completed

Study to Evaluate the Tolerability of Prebiotics on the Microbiota

NCT07105826Completed

Impact of Prebiotic Sodas on Satiety and Metabolic Responses in Healthy Men

NCT07127120Completed

Open Label Single Arm Prebiotic Pilot Trial SR001

NCT04164914Completed

Intestinal Microbiota Adaptation to Prebiotic Administration