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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

January 26, 2009
February 18, 2010
December 2008
February 2010   (final data collection date for primary outcome measure)
Calculation of area under the curve for glucose and insulin [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Calculation of area under the curve for glucose and insulin [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00831285 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Barley Tortillas Study in Healthy Volunteers
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Healthy
Dietary Supplement: food product
food product given at one of six visits
  • 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
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.
 
Completed
12
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00831285
B2008:133, Agriculture and Agri-food CAN
No
Dr. Carla Taylor, Department of Human Nutritional Science, University of Manitoba
University of Manitoba
Not Provided
Principal Investigator: Carla Taylor, PhD University of Manitoba
University of Manitoba
February 2010

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