- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01939600
Digestibility of Selected Resistant Starches in Humans
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5C 2N8
- Glycemic Index Laboratories, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: All subjects
All subjects will undergo all 4 treatments, starch-free breakfast, Hi-Maize 260, Hylon VII and Amioca in randomized order
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 10 hours after starting to consume breakfast
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 10 hours after starting to consume breakfast
|
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.
|
Up to 10 hours after starting to consume breakfast
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 10 hours after starting to consume breakfast
|
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.
|
Up to 10 hours after starting to consume breakfast
|
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.
|
Up to 10 hours after starting to consume breakfast
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas M. Wolever, MD, PhD, Unity Health Toronto
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIL-1322
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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