GlutDigest - Pilot Study

NCT04489836 | Completed

• 1 other identifier: Project 0470-Pilot study
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Main Focus: Gluten and Starch Digestibility

Keywords

Gluten; Starch; Digestive enzymes; Probiotics

Outcome Measures

Primary Outcomes (1)

• Undigested wheat protein after each treatment

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

  9-hour period after the test meal

Secondary Outcomes (4)

• 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

• Undigested food particles

  9-hour period after the test meal

Study Arms (2)

Meal A + Glutalytic®

EXPERIMENTAL

350 mg Glutalytic® capsule, taken by mouth, once, with Meal A

Dietary Supplement: Glutalytic®; Other: Meal A

Meal A + DE111®

EXPERIMENTAL

350 mg DE111® capsule, taken by mouth, once, with Meal A

Dietary Supplement: DE111®; Other: Meal A

Interventions

Glutalytic® DIETARY_SUPPLEMENT

Glutalytic® capsule

Meal A + Glutalytic®

DE111® DIETARY_SUPPLEMENT

DE111® capsule

Meal A + DE111®

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

Meal A + DE111®; Meal A + Glutalytic®

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Deerland Enzymes: lead
• Teagasc: collaborator
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Food Clinical Trials

Cork, Ireland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 28, 2020
• Study Start: August 31, 2020
• Primary Completion: September 19, 2020
• Study Completion: September 19, 2020
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)