Barley Tortillas Study in Healthy Volunteers

This study has been completed.

Sponsor:

Information provided by:

University of Manitoba

ClinicalTrials.gov Identifier:

NCT00831285

First received: January 26, 2009

Last updated: February 18, 2010

Last verified: February 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

January 26, 2009

Last Updated Date

February 18, 2010

Start Date ^ICMJE

December 2008

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Calculation of area under the curve for glucose and insulin [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Calculation of area under the curve for glucose and insulin [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00831285 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

comparison of food groups using ANOVA [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
measurement of incretins [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

comparion of food groups using ANOVA [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
measurement of incretins [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Barley Tortillas Study in Healthy Volunteers

Official Title ^ICMJE

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

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Dietary Supplement: food product

food product given at one of six visits

Study Arm (s)

Experimental: tortilla with high amylose flour
Intervention: Dietary Supplement: food product
Experimental: barley tortilla with low amylose flour
Intervention: Dietary Supplement: food product
Experimental: barley tortilla with low amylose flour and soluble fibre
Intervention: Dietary Supplement: food product
Experimental: barley tortilla with low amylose flour and insoluble fibre
Intervention: Dietary Supplement: food product
Active Comparator: glucose
Intervention: Dietary Supplement: food product
Experimental: barley tortilla with low amylose flour and low soluble fibre
Intervention: Dietary Supplement: food product

Publications *

Mäkeläinen H, Anttila H, Sihvonen J, Hietanen RM, Tahvonen R, Salminen E, Mikola M, Sontag-Strohm T. The effect of beta-glucan on the glycemic and insulin index. Eur J Clin Nutr. 2007 Jun;61(6):779-85. Epub 2006 Dec 6.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2010

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00831285

Other Study ID Numbers ^ICMJE

B2008:133, Agriculture and Agri-food CAN

Has Data Monitoring Committee

Responsible Party

Dr. Carla Taylor, Department of Human Nutritional Science, University of Manitoba

Study Sponsor ^ICMJE

University of Manitoba

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Carla Taylor, PhD

University of Manitoba

Information Provided By

University of Manitoba

Verification Date

February 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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