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Completed

NCT Number: NCT04489836

GlutDigest - Pilot Study

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

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Key information

Conditions

Main Focus: Gluten and Starch Digestibility

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlantia Food Clinical Trials

Cork, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glutalytic®

Dietary Supplement

Glutalytic® capsule

DE111®

Dietary Supplement

DE111® capsule

Meal A

Other

Oatmeal porridge - serving of oat porridge (cooked) containing 50g of carbohydrates (excluding sugars); Wheat cereal - serving of wheat cereal providing 1g of gluten; Water - 125 mL

Primary outcomes

  1. Undigested wheat protein after each treatment

    Time frame: 9-hour period after the test meal

    Difference between the mean concentration of undigested wheat protein in ileal effluent samples.

Secondary outcomes

  1. Vegetative DE111 cells

    Time frame: 9-hour period after the test meal

    Mean concentration of DE111® cells recovered in the ileal effluent samples.

  2. Glycemic response

    Time frame: At baseline, and at different time-points in the 9-hour period after consumption of the test meal.

    Difference between the mean area under the glucose concentration (measured in the interstitial fluid) curves following each treatment.

  3. Undigested starch

    Time frame: 9-hour period after the test meal

    Difference between the mean concentration of undigested starch in ileal effluent samples.

  4. Undigested food particles

    Time frame: 9-hour period after the test meal

    Pictures of undigested foods particles and microscopy will be combined for a combined assessment of macro- and micro- structural characteristics of the food particles recovered in ileal effluent samples.

Sponsors and collaborators

Lead sponsor

Deerland Enzymes

Industry

Collaborators

  • Atlantia Food Clinical Trials
  • Teagasc

Registry information

Official study title

GlutDigest - Enzymes-assisted Gluten Digestion (Pilot Study)

Acronym: GlutDigestP

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 28, 2020
Registry last updated
Oct 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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