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Completed NCT07744360

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

Conditions: GI Symptoms

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 80
Sponsor: Olipop, PBC

Location: People Science Los Angeles California

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.

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07744360). StuddyBuddy aggregates publicly available trial information.