Viewing Study NCT01939600



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Study NCT ID: NCT01939600
Status: COMPLETED
Last Update Posted: 2014-11-18
First Post: 2013-08-29

Brief Title: Digestibility of Selected Resistant Starches in Humans
Sponsor: Unity Health Toronto
Organization: Unity Health Toronto

Study Overview

Official Title: Digestibility of Selected Resistant Starches in Humans
Status: COMPLETED
Status Verified Date: 2014-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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 andor 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 andor 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
Detailed Description: 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 andor 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 andor 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None