Resistant starch content of bread made from high amylose wheat in adults with an ileostomy

Not Applicable

Completed

• Conditions: Gut health; Ileostomy; Diet and Nutrition - Other diet and nutrition disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12620000898954
• Lead Sponsor: CSIRO Health and Biosecurity

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-02-01
• Study Start: 2020-09-11
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Participants must have had minimal terminal ileum removed and have a conventional and well-functioning permanent ileostomy.
• Age 20-80 years.
• Willing to comply with alcohol and study diet restrictions.

Exclusion Criteria

• History of alcohol or drug abuse.
• Participation in a study within 30 days of commencement of the study.
• Presence of gastrointestinal, renal, hepatic disease or intestinal inflammation.
• Use of any medication that in the opinion of the investigator could interfere with the study or medications (eg antibiotics, codeine) likely to modulate small intestinal function.
• Definite or suspected personal history or family history of adverse events or intolerance of starchy or other foods, which may be tested in this study.
• Person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol and restrictions.
• Unwilling or unable to collect ileal effluent as required.
• Persons taking any supplements containing carbohydrates (in particular resistant starch such as Hi-maize) which could interfere with study parameters.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ileal starch digestibility (%) will be assessed by laboratory analysis of ileal digesta[48 hrs post commencement of consumption of each test bread (primary timepoint). <br>24 hr intervals (all fecal samples collected from 7am to 7am on the following day will be pooled prior to analysis)]

Secondary Outcome Measures

Name	Time	Method
ileal moisture content (%) will be assessed by laboratory analysis of ileal digesta[48 hrs post commencement of consumption of each test bread (primary timepoint). <br>24 hr intervals (all fecal samples collected from 7am to 7am on the following day will be pooled prior to analysis)]