NCT01939600

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 11, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

3 months

First QC Date

August 29, 2013

Last Update Submit

November 17, 2014

Conditions

Malabsorption; CarbohydrateIleostomy - Stoma

Keywords

Resistant starchIleostomyIn vivoCarbohydrate digestibility

Outcome Measures

Primary Outcomes (1)

  • Amount of carbohydrate in ileostomy effluent

    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 Outcomes (2)

  • Amount of fiber in ileostomy effluent

    Up to 10 hours after starting to consume breakfast

  • Amount of starch in ileostomy effluent

    Up to 10 hours after starting to consume breakfast

Other Outcomes (3)

  • Amount of fiber in ileostomy effluent

    Up to 10 hours after starting to consume breakfast

  • Amount of fiber in ileostomy effluent

    Up to 10 hours after starting to consume breakfast

  • Amount of starch in ileostomy effluent

    Up to 10 hours after starting to consume breakfast

Study Arms (1)

All subjects

EXPERIMENTAL

All subjects will undergo all 4 treatments, starch-free breakfast, Hi-Maize 260, Hylon VII and Amioca in randomized order

Other: Starch-free breakfastOther: Hi-Maize 260Other: Hylon VIIOther: Amioca

Interventions

Starch-free breakfastOTHER

Starch-free breakfast alone

All subjects
Hi-Maize 260OTHER

Starch-free breakfast plus 55.3g Hi-Maize 260

All subjects
Hylon VIIOTHER

Starch-free breakfast plus 56.9g Hylon VII

All subjects
AmiocaOTHER

Starch-free breakfast plus 56.4g amioca starch

All subjects

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • males or non-pregnant females with a conventional ileostomy
  • clinically stable with no clinical evidence of malabsorption

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glycemic Index Laboratories, Inc.

Toronto, Ontario, M5C 2N8, Canada

Location

MeSH Terms

Conditions

Malabsorption Syndromes

Interventions

high-amylose maize type 2 resistant starch, maizeAmylopectin

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

StarchDietary CarbohydratesCarbohydratesGlucansPolysaccharides

Study Officials

  • Thomas M. Wolever, MD, PhD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientist at Keenan Research Centre in the Li Ka Shing Knowledge Institute

Study Record Dates

First Submitted

August 29, 2013

First Posted

September 11, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2013

Study Completion

August 1, 2014

Last Updated

November 18, 2014

Record last verified: 2014-11

Locations

CA(1)