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

29. juli 2026 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Los Angeles, California, Forente stater, 90034
        • People Science

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Prebiotic Soda
Participants will be randomized to consume prebiotic soda intervention
Annen: Prebiotic Soda
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).
Ingen inngripen: Control (Usual Fluid Intake)
Participants will be randomized to continue consumption of their typical daily fluid intake.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Evaluate the impact of a prebiotic soda on gastrointestinal (GI) symptoms in users of GLP-1 agonists
Tidsramme: Baseline, week 1, week 2, and week 4
The Gastrointestinal Symptom Rating Scale (GSRS)
Baseline, week 1, week 2, and week 4

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Evaluate impact of a prebiotic soda on health-related quality of life
Tidsramme: Baseline and week 4
36-item Short Form Health Survey (SF-36)
Baseline and week 4
Evaluate the impact of a prebiotic soda on stool characteristics
Tidsramme: Completed daily from baseline to week 4
Modified Bristol Stool Scale (mBSS)
Completed daily from baseline to week 4
Evaluate the impact of prebiotic soda on habitual dietary intake
Tidsramme: Baseline, week 2, and week 4
Food Frequency Questionnaire
Baseline, week 2, and week 4
Evaluate the impact of a prebiotic soda on appetite
Tidsramme: Baseline, week 1, week 2, week 3, and week 4
Appetite Survey
Baseline, week 1, week 2, week 3, and week 4
Evaluate the impact of a prebiotic soda on body weight and BMI
Tidsramme: Baseline and week 4
Body Weight and Body Mass Index
Baseline and week 4
Evaluate the impact of a prebiotic soda on GI side effect medication use
Tidsramme: Daily throughout study (baseline to week 4)
Assessment on the type, frequency and dose of rescue medications used for GI side effects reported over the study
Daily throughout study (baseline to week 4)
Evaluate the impact of a prebiotic soda on AEs and SAEs.
Tidsramme: Weekly throughout study period (Week 1 through Week 4)
Assessment of the number, frequency, and severity of adverse events (AEs), serious adverse events (SAEs) and AE withdrawals reported over the product use period.
Weekly throughout study period (Week 1 through Week 4)
Evaluate the participant beverage satisfaction and experience of a prebiotic soda
Tidsramme: End of Study (week 4)
Experience/Feedback Survey
End of Study (week 4)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Olipop, PBC

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

10. februar 2026

Primær fullføring (Faktiske)

4. mai 2026

Studiet fullført (Faktiske)

4. juni 2026

Datoer for studieregistrering

Først innsendt

29. juli 2026

Først innsendt som oppfylte QC-kriteriene

29. juli 2026

Først lagt ut (Faktiske)

4. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • PS32

Plan for individuelle deltakerdata (IPD)

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NEI

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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