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Barley Tortillas Study in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00831285
First Posted: January 28, 2009
Last Update Posted: February 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Manitoba
  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: Triple (Participant, Care Provider, Investigator)
Official Title: A Double-Blind, Randomized, Controlled Study to Examine the Glycemic Response of Barley Tortillas in Healthy Volunteers

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 ]

Secondary Outcome Measures:
  • comparison of food groups using ANOVA [ Time Frame: 6 weeks ]
  • measurement of incretins [ Time Frame: 6 weeks ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: January 26, 2009
First Posted: January 28, 2009
Last Update Posted: February 22, 2010
Last Verified: February 2010

Keywords provided by University of Manitoba:
Healthy volunteers