GlutDigest - Enzymes-assisted Gluten Digestion (Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Undigested wheat protein after each treatment
研究概览
简要总结
This is a pilot, feasibility study to evaluate, test and optimize sample analysis procedures and protocols before the full-scale, crossover study is conducted.
详细描述
Two important factors can influence the proportions of gluten and starch that resist digestion: (1) enzyme availability and specificity and (2) the structural properties of the food. A complete evaluation of gluten digestion and of the impact of dietary supplements is difficult to conduct because it is not easy to obtain samples of digestive chime. The analysis of the ileal effluent of healthy ileostomy patients constitutes a non-invasive alternative to intubation techniques for the study of nutrient digestion and of the fate of probiotics in the small intestine.
The main aim of this study is to test and optimize sample analysis protocols before conducting the full-scale, crossover study which will aim at evaluating the impact of two dietary supplements (Glutalytic® and DE111®) and of oatmeal properties on the digestion of gluten and starch and on the glycemic response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has given written informed consent
- •Subject has an ileostomy stable for at least 3 months post-operative and shows normal stoma functions
- •Subject is otherwise healthy
- •Subject is available to participate in the study sessions on the proposed dates
排除标准
- •Subject has coeliac disease or allergy to wheat products and/or any other ingredients in the test meal and standard meals
- •Case of obstruction of the stoma in the past 3 months
- •Body mass index < 18 kg/m2 or > 30 kg/m
- •Diagnosed mouth, throat or active gastrointestinal pathology (other than ileostomy) that may affect normal ingestion and digestion of food.
- •History of pancreatic disease
- •Subject is immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy within the last year)
- •Subject has Type 1 or Type 2 diabetes mellitus.
- •Subject has a history of bariatric surgery.
- •Subject has a history of drug and/or alcohol abuse at the time of enrolment
- •Subject is currently participating in another study, or plans to participate in another study during the study period
- •Women of child-bearing potential who do not use an acceptable method of contraception
- •Pregnant or nursing (lactating) women
研究组 & 干预措施
Meal A + Glutalytic®
350 mg Glutalytic® capsule, taken by mouth, once, with Meal A
干预措施: Glutalytic® (Dietary Supplement)
Meal A + Glutalytic®
350 mg Glutalytic® capsule, taken by mouth, once, with Meal A
干预措施: Meal A (Other)
Meal A + DE111®
350 mg DE111® capsule, taken by mouth, once, with Meal A
干预措施: DE111® (Dietary Supplement)
Meal A + DE111®
350 mg DE111® capsule, taken by mouth, once, with Meal A
干预措施: Meal A (Other)
结局指标
主要结局
Undigested wheat protein after each treatment
时间窗: 9-hour period after the test meal
Difference between the mean concentration of undigested wheat protein in ileal effluent samples.
次要结局
- Undigested food particles(9-hour period after the test meal)
- Vegetative DE111 cells(9-hour period after the test meal)
- Glycemic response(At baseline, and at different time-points in the 9-hour period after consumption of the test meal.)
- Undigested starch(9-hour period after the test meal)