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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study AnnotationsStudy Notes

Notes added here are public and can be viewed by anyone. Notes added here are only available to you and those who you share with.

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.