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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Canada1 site
  • Glycemic Index Laboratories, Inc.

    Toronto, Ontario, M5C 2N8

Other trials in Canada

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.

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 groups in NCT01939600
Study groupRoleWhat they receive
All subjectsExperimentalAll 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted11 Sep 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionDec 2013
  4. Study completionAug 2014

Resources

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)
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

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.

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