The Effect of Gluten-free Diet on Gut Microbiota and Metabolic Regulation in People With Coeliac Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Concentration of blood glucose
研究概览
简要总结
High intake of dietary fiber provides health benefits and reduces the risk of developing cardio-metabolic diseases, such as type 2 diabetes (T2D) and cardiovascular disease (CVD). The intake of fiber is below the recommendations worldwide. In Norway, bread and cereals represent a major source of fiber. A low fiber intake is evident for people with celiac disease due to the removal of wheat, rye and barley from the diet. We therefore need to increase our knowledge in relation to fiber-rich food that will be tolerated also by people with celiac disease. The aim of the study is to investigate the effect of fiber rich gluten free products on blood glucose levels compared to benchmark gluten free products.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals with celiac disease
- •BMI 18.5-27
- •18-65 years
排除标准
- •chronic metabolic diseases, such as diabetes (type 1 and 2), cardiovascular diseases, cancer the last six months
- •gut diseases, including chron's disease, ulcerative colite
- •food allergies or intolerance, except for coliac disease
- •pregnant and/or lactating
- •BMI <18.5 and >27
- •planned weight reduction and/or 5% weight change the last three months
- •blood donor the last two months and during the study period
- •not willing to stop using dietary supplements, including probiotic products, cod liver oil etc, four weeks before and throughout the study
- •use of antibiotics < three months before study start and throughout the study period
- •alcohol consume > 40 g/day
- •hormone treatment (except for contraceptives)
研究组 & 干预措施
Optimised gluten-free products
Products containing less than 6g fibre per 100g product.
干预措施: Randomized, controlled trial (RCT) with parallel arms and double blinded (Dietary Supplement)
Benchmark gluten-free products
Products containing less than 6g fibre per 100g product.
干预措施: Randomized, controlled trial (RCT) with parallel arms and double blinded (Dietary Supplement)
结局指标
主要结局
Concentration of blood glucose
时间窗: 3 weeks
Blood analyses of glucose (fasting and post-prandial (after an OGTT)) before and after intervention with benchmark versus optimized gluten-free products.
次要结局
- Concentration of blood cholesterol, triglycerides, fatty acids, C-peptide(3 weeks)
- Concentration of blood inflammatory markers(3 weeks)
- Concentration of satiety hormones in blood(3 weeks)
- Bristol Stool Chart (BSC)(3 weeks)
- Gastrointestinal Symptoms Rating Scale-Irritable bowl syndrome (GSRS-IBS)(3 weeks)
- Feces microbiota analyses performed with Bio-Me's Precision Microbiome Profiling platform (PMP)(3 weeks)
研究者
Vibeke Telle-Hansen
Associate professor
Oslo Metropolitan University