The Effect of a Low FODMAP Oral Nutrition Supplement On Breath Hydrogen Response In Health Human Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Breath hydrogen response
研究概览
简要总结
The goal of this study is to determine subjective gastrointestinal tolerance response and differences in breath hydrogen response following the consumption of different types of low FODMAP oral nutrition supplements. This randomized, crossover study requires participants to arrive to the lab 12 hours fasted, consume an oral liquid supplement and complete gastrointestinal tolerance questionnaires as well as produce samples for breath hydrogen analysis at various time points over a 4 hour time period.
详细描述
This randomized, crossover study requires participants to arrive to the lab 12 hours fasted, consume an oral liquid supplement and complete gastrointestinal tolerance questionnaires as well as produce samples for breath hydrogen and methane analysis at various time points over a 4 hour time period. Subjects will also be asked to rate gastrointestinal symptoms via a questionnaire at various time points throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- •Between the ages of 18-65 years with a body mass index between 18-29 kg/m
- •Demonstrates spoken and written English literacy and able to provide written, informed consent after review of study protocol and procedures.
排除标准
- •Use of enemas, proton pump inhibitors, or antibiotics within the past 3 months
- •Not a regular breakfast eater
- •Self-reported history of a past or current gastrointestinal disease
- •High fiber eater (> or = to 3 servings of high fiber foods per day)
- •Concurrent or recent (within 30 days) participation in an intervention trial
- •Recent weight fluctuations
- •Allergies to any of the test products
研究组 & 干预措施
FOS Supplement
Supplement containing fructooligosaccharides
干预措施: Low FODMAP Oral Nutrition Supplement (Dietary Supplement)
Low FODMAP Oral Nutrition Supplement 1
Low FODMAP Oral Nutrition Supplement
干预措施: Low FODMAP Oral Nutrition Supplement (Dietary Supplement)
Low FODMAP Oral Nutrition Supplement 2
Low FODMAP Oral Nutrition Supplement
干预措施: Low FODMAP Oral Nutrition Supplement (Dietary Supplement)
Low FODMAP Oral Nutrition Supplement 3
Low FODMAP Oral Nutrition Supplement
干预措施: Low FODMAP Oral Nutrition Supplement (Dietary Supplement)
结局指标
主要结局
Breath hydrogen response
时间窗: 240 minutes
At 240 minutes, subjects will be asked to exhale a full breath into a sample collection bag. The breath samples will be extracted and measured using the Quintron Breath Track Analyzer. This will be a marker of carbohydrate fermentation.
Breath hydrogen response
时间窗: baseline
At baseline, subjects will be asked to exhale a full breath into a sample collection bag. The breath samples will be extracted and measured using the Quintron Breath Track Analyzer. This will be a marker of carbohydrate fermentation in the colon.
Breath hydrogen response
时间窗: 60 minutes
At 60 minutes, subjects will be asked to exhale a full breath into a sample collection bag. The breath samples will be extracted and measured using the Quintron Breath Track Analyzer. This will be a marker of carbohydrate fermentation in the colon.
Breath hydrogen response
时间窗: 120 minutes
At 120 minutes, subjects will be asked to exhale a full breath into a sample collection bag. The breath samples will be extracted and measured using the Quintron Breath Track Analyzer. This will be a marker of carbohydrate fermentation.
次要结局
- Gastrointestinal tolerance(48 hours)