Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Breath gases
研究概览
简要总结
The aim of the study is to compare self-reported gastrointestinal symptoms and intestinal fermentation rates of the study products as measured by breath hydrogen and methane in adult population with self-reported mild abdominal sensitivity to pulses. The study products are a pulse products with two different cereals.
详细描述
The study is a randomized, controlled, double-blind, cross-over intervention trial. The aim is to recruit 25 subjects to the trial. The study will be conducted with a cross-over setting, where the subjects will go through exposure meals and breath gas measurement two times (two different test products) in a randomized order. The study meals are identical in appearance but differ in fiber content. After study breakfast the breath gases are analyzed every 15 minutes during 8 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects with subjective experience of gut symptoms after consumption of pulses
- •Celiac disease and wheat allergy excluded by antigen test
- •Age 18-65
- •BMI 18,5 - 30
- •Normal liver, thyroid and kidney functions
排除标准
- •Celiac disease, Crohn's disease, ulcerative colitis or acute diverticulitis
- •Any medication affecting the gastrointestinal tract (e.g. laxatives and acid-suppressive drugs)
- •Antibiotic treatment within previous 3 months
- •Blood donation or participation to another clinical trial within one month prior to study entry
结局指标
主要结局
Breath gases
时间窗: Day 4
Breath hydrogen and methane are measured by Gastrocheck device.
次要结局
- Gastrointestinal symptoms (self-reported)(Day 1-4)
研究者
Kaisa Linderborg
Professor of Molecular Food Sciences (acting)
University of Turku