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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
  Purpose

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


Condition Intervention
Healthy
 Dietary Supplement: food product

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: A Double-Blind, Randomized, Controlled Study to Examine the Glycemic Response of Barley Tortillas in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Manitoba:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: December 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831285

Locations
Canada, Manitoba
St. Boniface General Hospital Research Centre
Winnipeg, Manitoba, Canada, R2H 2A6
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Carla Taylor, PhD University of Manitoba
  More Information

Additional Information:
Canadian Centre for AgriFood Research in Health and Medicine  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Dr. Carla Taylor, Department of Human Nutritional Science, University of Manitoba
ClinicalTrials.gov Identifier: NCT00831285     History of Changes
Other Study ID Numbers: B2008:133, Agriculture and Agri-food CAN
Study First Received: January 26, 2009
Last Updated: February 18, 2010
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
Healthy volunteers

ClinicalTrials.gov processed this record on October 18, 2012