Ileostomy - Stoma Clinical Trial
Official title:
Digestibility of Selected Resistant Starches in Humans
Verified date | November 2014 |
Source | St. Michael's Hospital, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
Dietary fiber is a type of carbohydrate which is not digested in the human small intestine. Whole grains are a source of dietary fiber that are used to promote health; however, using whole grains in commercial products results in a different taste and/or texture than the usual products made from refined grains. Thus, other types of high-fiber ingredients have been developed which can be incorporated into food products with less effect on their taste and/or texture. An example of this is resistant starch, defined as starch which is not digested in the human small intestine. The digestibility of starch is usually determined in-vitro; however, there is evidence that such methods may overestimate the amount of resistant starch by as much as 100%. The measurement of the amount of carbohydrate in the ileal effluent, digestive waste, of subjects with an ileostomy is considered to be the best in-vivo method of starch digestibility. The subjects collect ileal effluent during the day during which time they consume a polysaccharide-free diet. There is evidence that resistant starch consumed at breakfast is completely recovered in ileal effluent 8-10hr after consumption. The purpose of this study will be to compare the carbohydrate content recovered in ileal effluent of 10 subjects with a conventional ileostomy.
Status | Completed |
Enrollment | 3 |
Est. completion date | August 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - males or non-pregnant females with a conventional ileostomy - clinically stable with no clinical evidence of malabsorption Exclusion Criteria: - short bowel syndrome - acute exacerbation of inflammatory bowel disease - prone to high output with change in diet - ileostomy created less than 6 months from the first study visit - subjects using medications which influence gastrointestinal motility or absorption - any condition which might, in the opinion of Dr. Wolever or Dr. Kim either: 1) make participation dangerous to the subject or to others, or 2) affect the results - subjects who cannot or will not comply with the experimental procedures - food allergies of any kind |
Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Canada | Glycemic Index Laboratories, Inc. | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
St. Michael's Hospital, Toronto | Glycemic Index Laboratories, Inc, Ingredion Incorporated, Iowa State University, University of Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Amount of fiber in ileostomy effluent | Fiber will be measured using fiber assay 2009.01 and expressed in grams. | Up to 10 hours after starting to consume breakfast | No |
Other | Amount of fiber in ileostomy effluent | Fiber will be measured using fiber assay 991.43 and expressed in grams. | Up to 10 hours after starting to consume breakfast | No |
Other | Amount of starch in ileostomy effluent | Starch will be measured by acid hydrolysis and expressed in grams. | Up to 10 hours after starting to consume breakfast | No |
Primary | Amount of carbohydrate in ileostomy effluent | Carbohydrate in ileal effluent will be measured using by proximate analysis and expressed in grams. | Up to 10 hours after starting to consume breakfast | No |
Secondary | Amount of fiber in ileostomy effluent | Fiber is measured using the Englyst method and expressed in grams. | Up to 10 hours after starting to consume breakfast | No |
Secondary | Amount of starch in ileostomy effluent | Starch will be measured using the Megazyme assay and expressed in grams. | Up to 10 hours after starting to consume breakfast | No |
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