Malabsorption; CarbohydrateNCT01939600
Digestibility of Selected Resistant Starches in Humans
A study testing Starch-free breakfast, Hi-Maize 260 and Hylon VII in people with Malabsorption; Carbohydrate and Ileostomy - Stoma, run by Unity Health Toronto at 1 site in Canada.
Trial 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 and/or texture than the usual products made from refined grains. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malabsorption; Carbohydrate, Ileostomy - Stoma
- What is being tested?
- Starch-free breakfast, Hi-Maize 260 and Hylon VII
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- males or non-pregnant females with a conventional ileostomy
- clinically stable with no clinical evidence of malabsorption
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Malabsorption; Carbohydrate, Ileostomy - Stoma
- Being tested
- Starch-free breakfast, Hi-Maize 260, Hylon VII, Amioca
- Keywords
- Resistant starch, Ileostomy, In vivo, Carbohydrate digestibility
- Medical subject headings
- Malabsorption Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Starch-free breakfastOther
Starch-free breakfast alone
Hi-Maize 260Other
Starch-free breakfast plus 55.3g Hi-Maize 260
Hylon VIIOther
Starch-free breakfast plus 56.9g Hylon VII
AmiocaOther
Starch-free breakfast plus 56.4g amioca starch
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | All subjects will undergo all 4 treatments, starch-free breakfast, Hi-Maize 260, Hylon VII and Amioca in randomized order Receives: Other: Starch-free breakfast; Other: Hi-Maize 260; Other: Hylon VII; Other: Amioca |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of carbohydrate in ileostomy effluent
Carbohydrate in ileal effluent will be measured using by proximate analysis and expressed in grams.
Measured: Up to 10 hours after starting to consume breakfast
Secondary outcomes (2)
Amount of fiber in ileostomy effluent
Fiber is measured using the Englyst method and expressed in grams.
Measured: Up to 10 hours after starting to consume breakfast
Amount of starch in ileostomy effluent
Starch will be measured using the Megazyme assay and expressed in grams.
Measured: Up to 10 hours after starting to consume breakfast
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malabsorption; CarbohydrateStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ingredion Incorporated, University of Toronto, Glycemic Index Laboratories, Inc, Iowa State University
- Responsible party
- Principal investigator, Thomas Wolever, Unity Health Toronto
- Investigators
- Thomas M. Wolever, MD, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939600
- Sponsor's protocol ID
- GIL-1322
- Status last verified
- Nov 2014
- First submitted
- 29 Aug 2013
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digestibility of Selected Resistant Starches in Humans
- ClinicalTrials.gov ID
- NCT01939600
- Acronym / sponsor ID
- GIL-1322
- Conditions
- Malabsorption; Carbohydrate, Ileostomy - Stoma
- Keywords
- Resistant starch, Ileostomy, In vivo, Carbohydrate digestibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Ingredion Incorporated, University of Toronto, Glycemic Index Laboratories, Inc, Iowa State University
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 11 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Other: Starch-free breakfast, Other: Hi-Maize 260, Other: Hylon VII, Other: AmiocaAll subjects will undergo all 4 treatments, starch-free breakfast, Hi-Maize 260, Hylon VII and Amioca in randomized order |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- males or non-pregnant females with a conventional ileostomy
- clinically stable with no clinical evidence of malabsorption
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Starch-free breakfastStarch-free breakfast alone | Other | All subjects |
| Hi-Maize 260Starch-free breakfast plus 55.3g Hi-Maize 260 | Other | All subjects |
| Hylon VIIStarch-free breakfast plus 56.9g Hylon VII | Other | All subjects |
| AmiocaStarch-free breakfast plus 56.4g amioca starch | Other | All subjects |
Primary outcome
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.
2 secondary outcomes
Amount of fiber in ileostomy effluent
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas M. Wolever, MD, PhD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Starch-free breakfast, Hi-Maize 260 and Hylon VII in people with Malabsorption; Carbohydrate and Ileostomy - Stoma, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of carbohydrate in ileostomy effluent (time frame: Up to 10 hours after starting to consume breakfast). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2014.