GI Symptoms
Conditions
Keywords
GLP-1 agonist, GI Symptoms, Prebiotic Fiber, Digestive Health Support, Quality of Life
Brief 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.
Detailed description
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.
Interventions
OTHERPrebiotic 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).
Sponsors
Olipop, PBC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the impact of a prebiotic soda on gastrointestinal (GI) symptoms in users of GLP-1 agonists | Baseline, week 1, week 2, and week 4 | The Gastrointestinal Symptom Rating Scale (GSRS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate impact of a prebiotic soda on health-related quality of life | Baseline and week 4 | 36-item Short Form Health Survey (SF-36) |
| Evaluate the impact of a prebiotic soda on stool characteristics | Completed daily from baseline to week 4 | Modified Bristol Stool Scale (mBSS) |
| Evaluate the impact of prebiotic soda on habitual dietary intake | Baseline, week 2, and week 4 | Food Frequency Questionnaire |
| Evaluate the impact of a prebiotic soda on appetite | Baseline, week 1, week 2, week 3, and week 4 | Appetite Survey |
| Evaluate the impact of a prebiotic soda on body weight and BMI | Baseline and week 4 | Body Weight and Body Mass Index |
| Evaluate the impact of a prebiotic soda on GI side effect medication use | 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 |
| Evaluate the impact of a prebiotic soda on AEs and SAEs. | 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. |
| Evaluate the participant beverage satisfaction and experience of a prebiotic soda | End of Study (week 4) | Experience/Feedback Survey |
Countries
United States
Outcome results
None listed