GlutDigest - Pilot Study

  • STATUS
    Recruiting
  • participants needed
    6
  • sponsor
    Deerland Enzymes
Updated on 19 February 2024

Summary

This is a pilot, feasibility study to evaluate, test and optimize sample analysis procedures and protocols before the full-scale, crossover study is conducted.

Description

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.

Details
Condition Main Focus: Gluten and Starch Digestibility
Age 18years - 75years
Treatment Placebo, Glutalytic®, DE111®, Meal A
Clinical Study IdentifierNCT04489836
SponsorDeerland Enzymes
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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/m2
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
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