A Pilot Study Evaluating the Impact of a Prebiotic Soda on Gastrointestinal Symptoms in Users of GLP-1 Agonists
29 juli 2026 uppdaterad av: 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
80
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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California
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Los Angeles, California, Förenta staterna, 90034
- People Science
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Inget ingripande: Control (Usual Fluid Intake)
Participants will be randomized to continue consumption of their typical daily fluid intake.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Evaluate the impact of a prebiotic soda on gastrointestinal (GI) symptoms in users of GLP-1 agonists
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Evaluate impact of a prebiotic soda on health-related quality of life
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
10 februari 2026
Primärt slutförande (Faktisk)
4 maj 2026
Avslutad studie (Faktisk)
4 juni 2026
Studieregistreringsdatum
Först inskickad
29 juli 2026
Först inskickad som uppfyllde QC-kriterierna
29 juli 2026
Första postat (Faktisk)
4 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- PS32
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