A Pilot Study Evaluating the Impact of a Prebiotic Soda on Gastrointestinal Symptoms in Users of GLP-1 Agonists
29 juli 2026 bijgewerkt door: Olipop, PBC
An Open-label, Randomized Controlled Pilot Study Evaluating the Impact of a Prebiotic Soda on Gastrointestinal Symptoms in Users of GLP-1 Agonists
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.
Studie Overzicht
Gedetailleerde beschrijving
The primary aim of this study is to evaluate the effects of including a daily prebiotic soda (i.e., OLIPOP) over a 4-week period on gastrointestinal (GI) symptoms in adults who recently initiated GLP-1 receptor agonist (GLP-1 RA).
The study design is exploratory in nature and is set up as a real-world at-home, randomized two-arm study. Participants (n=80) will have initiated GLP-1 RA therapy for weight management at least 1 week but no greater than 4 weeks prior to study enrollment and have at least one reported GI symptom at enrollment. Participants will be randomized to either a control group (continuing to drink their usual fluid intake) or a behavioral intervention group (OLIPOP prebiotic soda,1 can (12 fl oz., 6 g dietary fiber)/day, with the option to consume 2 cans (24 fl oz., 12 g dietary fiber)/day, if desired).
Secondary outcomes will include evaluating the effects of prebiotic soda consumption on additional markers of digestive health support (i.e., bowel frequency and stool consistency), health-related quality of life, body weight and BMI, habitual dietary intake, appetite, GI symptom rescue medication usage, safety profile (AE/SAE) and participant experience and satisfaction.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
80
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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California
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Los Angeles, California, Verenigde Staten, 90034
- People Science
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Prebiotic Soda
Participants will be randomized to consume prebiotic soda intervention
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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).
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Geen tussenkomst: Control (Usual Fluid Intake)
Participants will be randomized to continue consumption of their typical daily fluid intake.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Evaluate the impact of a prebiotic soda on gastrointestinal (GI) symptoms in users of GLP-1 agonists
Tijdsspanne: Baseline, week 1, week 2, and week 4
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The Gastrointestinal Symptom Rating Scale (GSRS)
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Baseline, week 1, week 2, and week 4
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Evaluate impact of a prebiotic soda on health-related quality of life
Tijdsspanne: Baseline and week 4
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36-item Short Form Health Survey (SF-36)
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Baseline and week 4
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Evaluate the impact of a prebiotic soda on stool characteristics
Tijdsspanne: Completed daily from baseline to week 4
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Modified Bristol Stool Scale (mBSS)
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Completed daily from baseline to week 4
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Evaluate the impact of prebiotic soda on habitual dietary intake
Tijdsspanne: Baseline, week 2, and week 4
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Food Frequency Questionnaire
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Baseline, week 2, and week 4
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Evaluate the impact of a prebiotic soda on appetite
Tijdsspanne: Baseline, week 1, week 2, week 3, and week 4
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Appetite Survey
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Baseline, week 1, week 2, week 3, and week 4
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Evaluate the impact of a prebiotic soda on body weight and BMI
Tijdsspanne: Baseline and week 4
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Body Weight and Body Mass Index
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Baseline and week 4
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Evaluate the impact of a prebiotic soda on GI side effect medication use
Tijdsspanne: Daily throughout study (baseline to week 4)
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Assessment on the type, frequency and dose of rescue medications used for GI side effects reported over the study
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Daily throughout study (baseline to week 4)
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Evaluate the impact of a prebiotic soda on AEs and SAEs.
Tijdsspanne: Weekly throughout study period (Week 1 through Week 4)
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Assessment of the number, frequency, and severity of adverse events (AEs), serious adverse events (SAEs) and AE withdrawals reported over the product use period.
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Weekly throughout study period (Week 1 through Week 4)
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Evaluate the participant beverage satisfaction and experience of a prebiotic soda
Tijdsspanne: End of Study (week 4)
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Experience/Feedback Survey
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End of Study (week 4)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
10 februari 2026
Primaire voltooiing (Werkelijk)
4 mei 2026
Studie voltooiing (Werkelijk)
4 juni 2026
Studieregistratiedata
Eerst ingediend
29 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
29 juli 2026
Eerst geplaatst (Werkelijk)
4 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
4 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
29 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- PS32
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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