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Completed

NCT Number: NCT00831285

Barley Tortillas Study in Healthy Volunteers

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

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Boniface General Hospital Research Centre

Winnipeg, Manitoba, R2H 2A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

food product

Dietary Supplement

food product given at one of six visits

Primary outcomes

  1. Calculation of area under the curve for glucose and insulin

    Time frame: 6 weeks

Secondary outcomes

  1. comparison of food groups using ANOVA

    Time frame: 6 weeks

  2. measurement of incretins

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 28, 2009
Registry last updated
Feb 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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