NCT05762965已完成不适用
Effect of Galacto-oligosaccharides (GOS) on Faecal Gut Microbiota in Adult Women
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- faecal abundance of Bifidobacterium
研究概览
简要总结
Within the Denali study the effect of 3 weeks intervention with GOS on the abundance of Bifidobacterium in faecal samples will be investigated.
详细描述
This randomized, parallel, double-blinded intervention study of 6 weeks will include 88 females, who will consume GOS for three consecutive weeks. Faecal samples will be collected at several time points to measure microbiota composition.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy women
- •Aged between 40 - 70 year
- •Body Mass Index (BMI) between 18.5 - 30 kg/m2
排除标准
- •Having a gastro-intestinal disease, such as celiac disease, Crohn's disease, Ulcerative colitis, or diagnosed irritable bowel syndrome;
- •Having a history of intestinal surgery that might interfere with study outcomes. This does not include an appendectomy or cholecystectomy;
- •Diagnosed with diabetes mellitus;
- •Use of medication that may influence the study results, such as laxatives, lactase preparations, metformin, antibiotics, proton pomp inhibitors, antipsychotics, NSAID's (judged by our research physician);
- •Self-perceived and diagnosed constipation;
- •Having a food allergy to cow's milk or being lactose intolerant;
- •Self-reported slimming, medically prescribed or other diets
- •Reported weight loss or weight gain of >5kg in the month prior to screening
- •Use of (foods with) pre-, pro-, syn- and/or postbiotics* (should be stopped at least 4 weeks before the start of the study), or other supplements that can influence the study results (to be determined by the medical investigator);
- •History of side effects with the use of prebiotic supplements
- •Use of antibiotic treatment less than 3 months before start of the study
- •Pregnant or lactating (or having the wish to become pregnant during the study period, self-reported);
- •Not able to comply with study procedures;
- •Use of drugs (should be stopped at least 4 weeks before the study);
- •Alcohol intake ≥7 glasses of alcoholic beverages per week, on average
- •Participation in another clinical trial at the same time;
- •Being an employee of the Food, Health & Consumer Research group of Wageningen Food & Biobased Research or employee of FrieslandCampina R&D.
结局指标
主要结局
faecal abundance of Bifidobacterium
时间窗: At week 3 (end intervention)
faecal abundance of Bifidobacterium.
次要结局
- Faecal microbiota composition(At week 3 (end intervention))
研究者
Diederik Esser
Project leader clinical trials
Wageningen University and Research
研究点 (1)
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