Barley Tortillas Study in Healthy Volunteers

February 18, 2010 updated by: University of Manitoba

A Double-Blind, Randomized, Controlled Study to Examine the Glycemic Response of Barley Tortillas in Healthy Volunteers

The variation in starch and fibre composition of prepared barley tortillas will have a significant effect on glycemic response.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Specifically, we wish to examine the glycemic response of barley tortillas containing different ratios of amylose and amylopectin and different amounts of soluble and insoluble fibre with an appropriate control during acute phase testing in healthy volunteers. Possible relationships between composition of the barley tortillas and the degree of physiological response will also be investigated as the secondary objective.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface General Hospital Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male or female age 18 to 40 years
  • normal glycated hemoglobin of <6%
  • BMI of 20 to 30
  • must read the consent form
  • must comply with the protocol requirements

Exclusion Criteria:

  • allergies to barley flour
  • presence of chronic conditions such as cardiovascular disease, hypertension, disorders affecting the gastrointestinal tract, thyroid disease, and requiring medication for these conditions
  • requiring medication for glycemic control
  • consumption of supplements which have an effect on blood glucose response

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tortilla with high amylose flour
Dietary supplement: food product
food product given at one of six visits
Experimental: barley tortilla with low amylose flour
Dietary supplement: food product
food product given at one of six visits
Experimental: barley tortilla with low amylose flour and soluble fibre
Dietary supplement: food product
food product given at one of six visits
Experimental: barley tortilla with low amylose flour and insoluble fibre
Dietary supplement: food product
food product given at one of six visits
Active Comparator: glucose
Dietary supplement: food product
food product given at one of six visits
Experimental: barley tortilla with low amylose flour and low soluble fibre
Dietary supplement: food product
food product given at one of six visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Calculation of area under the curve for glucose and insulin
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
comparison of food groups using ANOVA
Time Frame: 6 weeks
6 weeks
measurement of incretins
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Investigators

  • Principal Investigator: Carla Taylor, PhD, University of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

January 26, 2009

First Submitted That Met QC Criteria

January 27, 2009

First Posted (Estimate)

January 28, 2009

Study Record Updates

Last Update Posted (Estimate)

February 22, 2010

Last Update Submitted That Met QC Criteria

February 18, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B2008:133
  • Agriculture and Agri-food CAN

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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