Glycemic Index Laboratories, Inc.
Toronto, Ontario, M5C 2N8, Canada
NCT Number: NCT01939600
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.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Toronto, Ontario, M5C 2N8, Canada
Dietary fiber consists mainly of carbohydrates which are not digested in the human small intestine. A high intake of dietary fiber is associated with many health benefits including, but not limited to, improved bowel function and reduced risk of weight gain, cardiovascular disease and diabetes. Therefore, there is great interest in the food industry to produce products enriched with dietary fiber to promote health. One way to achieve this is to use more whole grains (wheat, rice, oats, barley) as ingredients in products such as breakfast cereals, breads and food bars. However, the use of whole grains results in products which have 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. Examples of such ingredients are inulin (an oligosaccharide containing fructose) and resistant starch. Resistant starch, defined as starch which is not digested in the human small intestine, is present in small amounts (2-5% of total starch) in many normal foods.
Starch is the most abundant energy containing nutrient in the human diet; it consists of 2 types of polysaccharides: amylose, is a linear polymer consisting of long chains of glucose molecules joined by 1-4 linkages; and amylopectin, a highly branched polymer consisting of long chains of glucose molecules joined by 1-4 linkages with numerous 1-6 linkage branch points. Most (70-80%) of the starch in normal starchy foods (eg. cereals and potatoes) is amylopectin. Amylopectin is highly digestible because its branched structure makes it readily able to gelatinize, the process whereby adjacent starch molecules swell and separate from each other under the influence of moist heat (ie. cooking). By contrast amylose is less digestible because its linear structure allows adjacent molecules to associate by hydrogen bonding which reduces their ability to gelatinize. Some types of commercially available resistant starch come from strains of corn which produce starch containing 70 to 100% amylose.
The digestibility of starch is usually determined in-vitro using methods involving digestion of the starch with α-amylase under pH and temperature conditions thought to mimick digestion in the human small intestine. However, there is evidence that such methods may overestimate the amount of resistant starch by as much as 100%. Methods used to estimate starch digestibility in-vivo include the breath hydrogen method and the measurement of the amount of carbohydrate in the ileal effluent of subjects with an ileostomy. The latter is considered to be the best in-vivo method which involves preparation of subjects with a polysaccharide-free diet the day before then consumption of the test carbohydrate with breakfast. 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 objective of this study is to determine the amount of carbohydrates in 3 commercially available starches (Hi-Maize® 260, Hylon® VII and Amioca corn starch) which escape digestion in the human small intestine.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Starch-free breakfast alone
Starch-free breakfast plus 55.3g Hi-Maize 260
Starch-free breakfast plus 56.9g Hylon VII
Starch-free breakfast plus 56.4g amioca starch
Time frame: Up to 10 hours after starting to consume breakfast
Carbohydrate in ileal effluent will be measured using by proximate analysis and expressed in grams.
Time frame: Up to 10 hours after starting to consume breakfast
Fiber is measured using the Englyst method and expressed in grams.
Time frame: Up to 10 hours after starting to consume breakfast
Starch will be measured using the Megazyme assay and expressed in grams.
Time frame: Up to 10 hours after starting to consume breakfast
Fiber will be measured using fiber assay 2009.01 and expressed in grams.
Time frame: Up to 10 hours after starting to consume breakfast
Fiber will be measured using fiber assay 991.43 and expressed in grams.
Time frame: Up to 10 hours after starting to consume breakfast
Starch will be measured by acid hydrolysis and expressed in grams.
Unity Health Toronto
Other
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.
Published trials that share one or more normalized conditions with this study.
NCT06648967
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Digestive System Diseases
Phoenix, Arizona, United States
View Trial DetailsNCT04577456
Digestive System Diseases, Digestive System Fistula
Gainesville, Florida, United States
View Trial DetailsNCT06897163
Ileostomy - Stoma
Copenhagen, Denmark
View Trial DetailsNCT06320002
Colostomy Stoma, Ileostomy - Stoma
Boston, Massachusetts, United States
View Trial Details