Effect of 6 Weeks Daily Consumption of a Cereal-based Juice Beverage on Gastrointestinal Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Stool volume
研究概览
简要总结
The project is a randomized, 2-way, blinded parallel trial in which 56 healthy adults of both genders with frequent occurrence of stomach trouble.This intervention trial with 6 weeks of daily intake β-glucans will be carried out with a beverage containing β-glucans and a control beverage without β-glucans. The primary aim is to investigate whether β-glucans from barley has an effect on stomach and intestinal health, including stool volume and frequency. Microbiota, concentrations of short chain fatty acids (butyrate, propionate, acetate), calprotectin, and energy and fat content in feces. Furthermore, blood pressure and exhaled hydrogen and methane, before and after the intervention, subjective perception of gastrointestinal problems and digestion as well as the participants' attitudes towards functional foods are measured using Visual Analog Scale (VAS).
Further, specific metabolites of β-glucans in urine (exploratory endpoint) and certain toxic metabolites from the microbiota using metabolite profiling (metabolomics) are also analyzed
详细描述
β-glucans from barley slows gastric emptying rate and prolongs the transit time of food in the small intestine." The relatively undigested β-glucans have the ability to increase satiety and stimulate digestion, ensuring regular bowel movements and relieve sluggish bowel movements, including constipation and constipation. β-glucans are fermented down in the large intestine, resulting in production of short-chain fatty acids which inhibit the biosynthesis of cholesterol, hence blood cholesterol levels are lowered (not the goal here). Subsequently, β-glucans may also affect blood pressure. As a direct result of the effects in the intestine, there will be an improvement in the quality of life for people with stomach upsets and maybe a reduction in the risk of cardiovascular disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The beverages are provided to the investigator and volunteers with similar color, taste and bottles, only labelled A or B.
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 20 - 27 kg/m2
- •Like test and control drink, pasta, meat sauce as these foods are part of the test meal.
- •Healthy subjects sometimes or often bothered by mild gastric problems such as bloating, loose stools or constipation
- •Willing to handle in 2 x 3-day total feces at the start and end of the study
排除标准
- •Suffering from irritable bowel syndrome (IBS), bacterial overgrowth in the small intestine (SIBO) or inflammatory bowel disease (IBD).
- •Systemic infections, psychiatric or metabolic diseases, and any clinical condition
- •Chronic or frequent use of medication (including blood thinners, excluding contraceptives)
- •Frequent loose stools
- •Blood donations during or in the month leading up to the study period
- •Elite athletes (> 10 hours of hard exercise / week, self-reported)
- •High intake of alcohol (defined as a weekly intake of > 7 units for women and > 14 units for men),
- •Have or have had a drug addiction
- •Participation in other scientific studies during the study period
- •Lactating
- •Pregnancy or ongoing planning of pregnancy
- •Vegetarianism or veganism.
结局指标
主要结局
Stool volume
时间窗: 0 and 6 weeks
Changes in total stool weight 2 x 3 days from 72 hours before study start and 72 hours before study termination after 6 weeks, determined by a mixed model analysis.
次要结局
- Hydrogen(0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min)
- Fecal concentrations of SCFA(0 and 6 weeks)
- Hydrogen Area Under the Curve(-2, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min)
- Determination and variations in fecal microbiota(0 and 6 weeks)
- Methane(0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min)
- Methane Area Under the Curve(-2, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min)
- Fecal concentrations of calprotectin(0 and 6 weeks)
研究者
Professor Lars Ove Dragsted
Professor
University of Copenhagen