Study to Evaluate the Efficacy of Poppi Apple Cider Vinegar Prebiotic Soda to Improve Gut Health In Participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change in IBS symptoms [Time Frame: Baseline to 4 weeks)
研究概览
简要总结
This exploratory observational trial provides the opportunity to gather information on the effect of daily consumption of Poppi Apple Cider Vinegar Prebiotic Soda on gut health and digestion.
详细描述
Individuals aged 18+ with a BMI under 30 and self-reported regular issues with IBS and/or poor digestion symptoms, including bloating, gassiness, heartburn, abdominal pain, constipation or associated symptoms (self-reported), but otherwise healthy will be chosen to participate in the study (see "4. Participant Definition"). Participants will be advised to discontinue any other oral supplement targeting the gut, including antibiotics, during the study and at least 3 months prior to.
Participants will be asked to complete the baseline survey on gut and skin health before the study starts.
Participants will also be asked to discontinue any additional soda consumption during the study.
Each day in the morning, for lunch, or in the afternoon, participants will drink one 12 fl oz. can of Poppi ACV prebiotic soda.
After 2 full weeks (day 14 of the study period) of drinking Poppi daily, participants will complete the 2-week follow up survey of gut and skin health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-45
- •Male or Female
- •Must be in generally good health
- •BMI under 35
- •Self-reported issues with gas, bloating, heartburn/acid reflux, abdominal pain or digestion
- •Willing to maintain their standard dietary pattern, activity level and body weight for the duration of the study
排除标准
- •Severe chronic conditions, including oncological conditions or psychiatric disease
- •Currently pregnant, wanting to become pregnant, or breastfeeding for the duration of the study
- •Taking any prescription medication targeting the gut
- •Taking any supplements targeting the gut in the past month
- •Use of antibiotics in the past 3 months
结局指标
主要结局
Change in IBS symptoms [Time Frame: Baseline to 4 weeks)
时间窗: 4 weeks
Survey-based assessment (0-5 scale) of changes in IBS symptoms with higher scores representing an improved outcome.
Change in bowel movements [Time Frame: Baseline to 4 weeks)
时间窗: 4 weeks
Survey-based assessment (0-5 scale) of changes in stool frequency and consistency (constipation vs. diarrhea vs. normal) with higher scores representing an improved outcome.
Change in skin health [Time Frame: Baseline to 4 weeks)
时间窗: 4 weeks
Survey-based assessment (0-5 scale) of changes in perceived skin health with higher scores representing an improved outcome.
次要结局
未报告次要终点