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