GlutDigest - Enzymes-assisted Gluten Digestion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Undigested wheat protein
研究概览
简要总结
This study evaluates the impact of two dietary supplements (Elevase® and DE111®) and of oatmeal properties on the digestion of gluten and starch and on the glycemic response.
详细描述
RATIONALE 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.
Elevase®, is a dietary supplement based on an enzyme preparation which effectively degrades gluten in vitro (Healey, Hall et al. unpublished). As it has also been found that the rate of wheat protein digestion can be increased in the presence of amylases (Smith, Pan et al. 2015), Elevase® is also enriched with amylase to aid in starch digestion.
The structural properties of food are influenced by numerous factors including meal preparation practices. Two common practices that can influence nutrient availability differently are heating vs. refrigerating (e.g. oat porridge vs. soaked and refrigerated oats).
Bacillus subtilis DE111® can produce and secrete many enzymes, including proteases, which, if secreted into the environment of the digestive tract, could support digestion and, in particular, the digestion of gluten. However, it is not clear whether diet supplementation with DE111 is a physiologically viable approach in terms of probiotic survival in the gastrointestinal tract.
PURPOSE The aims of this study are to better understand the impact of each of these factors and whether supplementation with probiotic spores is a viable option.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
结局指标
主要结局
Undigested wheat protein
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
- Glycemic response(At baseline, and at different time-points during 9 hours after after consuming the test meal.)
- Undigested starch(At baseline and once every hour in the 9-hour period after consumption of the test meal.)
- Vegetative DE111 cells(9-hour period after the test meal)
- Undigested food particles(9-hour period after the test meal)