An Open-label, Randomized Controlled Pilot Study Evaluating the Impact of a Prebiotic Soda on Gastrointestinal Symptoms in Users of GLP-1 Agonists
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Evaluate the impact of a prebiotic soda on gastrointestinal (GI) symptoms in users of GLP-1 agonists
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Evaluate the impact of a prebiotic soda on gastrointestinal (GI) symptoms in users of GLP-1 agonists
时间窗: Baseline, week 1, week 2, and week 4
The Gastrointestinal Symptom Rating Scale (GSRS)
次要结局
- Evaluate impact of a prebiotic soda on health-related quality of life(Baseline and week 4)
- Evaluate the impact of a prebiotic soda on stool characteristics(Completed daily from baseline to week 4)
- Evaluate the impact of prebiotic soda on habitual dietary intake(Baseline, week 2, and week 4)
- Evaluate the impact of a prebiotic soda on appetite(Baseline, week 1, week 2, week 3, and week 4)
- Evaluate the impact of a prebiotic soda on body weight and BMI(Baseline and week 4)
- Evaluate the impact of a prebiotic soda on GI side effect medication use(Daily throughout study (baseline to week 4))
- Evaluate the impact of a prebiotic soda on AEs and SAEs.(Weekly throughout study period (Week 1 through Week 4))
- Evaluate the participant beverage satisfaction and experience of a prebiotic soda(End of Study (week 4))