A Pilot Study Evaluating the Impact of a Prebiotic Soda on Gastrointestinal Symptoms in Users of GLP-1 Agonists
29 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
80
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
California
-
Los Angeles, California, Estados Unidos, 90034
- People Science
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Prebiotic Soda
Participants will be randomized to consume prebiotic soda intervention
|
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).
|
|
Sin intervención: Control (Usual Fluid Intake)
Participants will be randomized to continue consumption of their typical daily fluid intake.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Evaluate the impact of a prebiotic soda on gastrointestinal (GI) symptoms in users of GLP-1 agonists
Periodo de tiempo: Baseline, week 1, week 2, and week 4
|
The Gastrointestinal Symptom Rating Scale (GSRS)
|
Baseline, week 1, week 2, and week 4
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Evaluate impact of a prebiotic soda on health-related quality of life
Periodo de tiempo: 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
Periodo de tiempo: 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
|
|
Evaluate the impact of prebiotic soda on habitual dietary intake
Periodo de tiempo: Baseline, week 2, and week 4
|
Food Frequency Questionnaire
|
Baseline, week 2, and week 4
|
|
Evaluate the impact of a prebiotic soda on appetite
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Daily throughout study (baseline to week 4)
|
|
Evaluate the impact of a prebiotic soda on AEs and SAEs.
Periodo de tiempo: 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)
|
|
Evaluate the participant beverage satisfaction and experience of a prebiotic soda
Periodo de tiempo: End of Study (week 4)
|
Experience/Feedback Survey
|
End of Study (week 4)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
10 de febrero de 2026
Finalización primaria (Actual)
4 de mayo de 2026
Finalización del estudio (Actual)
4 de junio de 2026
Fechas de registro del estudio
Enviado por primera vez
29 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de julio de 2026
Publicado por primera vez (Actual)
4 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- PS32
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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