Trial record 9 of 62 for:    Open Studies | "Malabsorption Syndromes"

Digestibility of Selected Resistant Starches in Humans

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by St. Michael's Hospital, Toronto
Sponsor:
Collaborators:
Ingredion Incorporated
University of Toronto
Glycemic Index Laboratories, Inc
Iowa State University
Information provided by (Responsible Party):
Thomas Wolever, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01939600
First received: August 29, 2013
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Malabsorption; Carbohydrate
Ileostomy - Stoma
Other: Starch-free breakfast
Other: Hi-Maize 260
Other: Hylon VII
Other: Amioca

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Digestibility of Selected Resistant Starches in Humans

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Amount of carbohydrate in ileostomy effluent [ Time Frame: Up to 10 hours after starting to consume breakfast ] [ Designated as safety issue: No ]
    Carbohydrate in ileal effluent will be measured using by proximate analysis and expressed in grams.


Secondary Outcome Measures:
  • Amount of fiber in ileostomy effluent [ Time Frame: Up to 10 hours after starting to consume breakfast ] [ Designated as safety issue: No ]
    Fiber is measured using the Englyst method and expressed in grams.

  • Amount of starch in ileostomy effluent [ Time Frame: Up to 10 hours after starting to consume breakfast ] [ Designated as safety issue: No ]
    Starch will be measured using the Megazyme assay and expressed in grams.


Other Outcome Measures:
  • Amount of fiber in ileostomy effluent [ Time Frame: Up to 10 hours after starting to consume breakfast ] [ Designated as safety issue: No ]
    Fiber will be measured using fiber assay 2009.01 and expressed in grams.

  • Amount of fiber in ileostomy effluent [ Time Frame: Up to 10 hours after starting to consume breakfast ] [ Designated as safety issue: No ]
    Fiber will be measured using fiber assay 991.43 and expressed in grams.

  • Amount of starch in ileostomy effluent [ Time Frame: Up to 10 hours after starting to consume breakfast ] [ Designated as safety issue: No ]
    Starch will be measured by acid hydrolysis and expressed in grams.


Estimated Enrollment: 10
Study Start Date: September 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All subjects
All subjects will undergo all 4 treatments, starch-free breakfast, Hi-Maize 260, Hylon VII and Amioca in randomized order
Other: Starch-free breakfast
Starch-free breakfast alone
Other: Hi-Maize 260
Starch-free breakfast plus 55.3g Hi-Maize 260
Other: Hylon VII
Starch-free breakfast plus 56.9g Hylon VII
Other: Amioca
Starch-free breakfast plus 56.4g amioca starch

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01939600

Contacts
Contact: Thomas M. Wolever, MD, PhD 416-978-5556 thomas.wolever@utoronto.ca
Contact: Asmaa M. Alraefaei, B.Sc. 647-963-9951 asmaa.alraefaei@mail.utoronto.ca

Locations
Canada, Ontario
Glycemic Index Laboratories, Inc. Not yet recruiting
Toronto, Ontario, Canada, M5C 2N8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Ingredion Incorporated
University of Toronto
Glycemic Index Laboratories, Inc
Iowa State University
Investigators
Principal Investigator: Thomas M. Wolever, MD, PhD St. Michael's Hospital, Toronto
  More Information

No publications provided

Responsible Party: Thomas Wolever, Scientist at Keenan Research Centre in the Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01939600     History of Changes
Other Study ID Numbers: GIL-1322
Study First Received: August 29, 2013
Last Updated: September 5, 2013
Health Authority: Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
Resistant starch
Ileostomy
In vivo
Carbohydrate digestibility

Additional relevant MeSH terms:
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 01, 2014