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Completed

NCT Number: NCT01939600

Digestibility of Selected Resistant Starches in Humans

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glycemic Index Laboratories, Inc.

Toronto, Ontario, M5C 2N8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Starch-free breakfast

Other

Starch-free breakfast alone

Hi-Maize 260

Other

Starch-free breakfast plus 55.3g Hi-Maize 260

Hylon VII

Other

Starch-free breakfast plus 56.9g Hylon VII

Amioca

Other

Starch-free breakfast plus 56.4g amioca starch

Primary outcomes

  1. Amount of carbohydrate in ileostomy effluent

    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.

Secondary outcomes

  1. Amount of fiber in ileostomy effluent

    Time frame: Up to 10 hours after starting to consume breakfast

    Fiber is measured using the Englyst method and expressed in grams.

  2. Amount of starch in ileostomy effluent

    Time frame: Up to 10 hours after starting to consume breakfast

    Starch will be measured using the Megazyme assay and expressed in grams.

Other outcomes

  1. Amount of fiber in ileostomy effluent

    Time frame: Up to 10 hours after starting to consume breakfast

    Fiber will be measured using fiber assay 2009.01 and expressed in grams.

  2. Amount of fiber in ileostomy effluent

    Time frame: Up to 10 hours after starting to consume breakfast

    Fiber will be measured using fiber assay 991.43 and expressed in grams.

  3. Amount of starch in ileostomy effluent

    Time frame: Up to 10 hours after starting to consume breakfast

    Starch will be measured by acid hydrolysis and expressed in grams.

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • Glycemic Index Laboratories, Inc
  • Ingredion Incorporated
  • Iowa State University
  • University of Toronto

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Sep 11, 2013
Registry last updated
Nov 18, 2014

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.

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