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Completed

NCT Number: NCT01828671

A Study to Examine the Glycemic Response of Corn and Soy Tortillas in Healthy Individuals

Tortillas are a staple food in several cultures and are widely used to make tacos, burritos, and enchiladas. These foods are gaining a significant segment of the North American fast food and restaurant industry. From a health point of view, the addition of soy flour into corn tortillas will improve the nutritional profile of the tortillas and the presence of soy protein, dietary fibre and bioactive components has the potential to yield other health benefits. It is hypothesized that the addition of soy flour to corn tortillas will lower the glycemic index which could benefit those individuals with type 2 diabetes.

The purpose of this research is to investigate whether different levels of soy flour in corn tortillas influences the glycemic response.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Boniface General Hospital - Asper Clinical Research Institute

Winnipeg, Manitoba, R2H 2A6, Canada

About this study

Soybeans are an important crop in Canada, with approximately 10% of soybean production in Manitoba. Soybeans are grown primarily for their oil. The press cake that remains following oil extraction is a good source of protein and contains bioactive ingredients such as the isoflavones. The press cake can be ground into a flour (soy flour) and used in food products. For example, a finely ground flour can be used in infant formulas as well as for meat and dairy substitutes. This research is examining other applications of soy flour in food products such as corn tortillas. Tortillas are a staple food in several cultures and are widely used to make tacos, burritos, and enchiladas. These foods are gaining a significant segment of the North American fast food and restaurant industry. From a health point of view, the addition of soy flour into corn tortillas will improve the nutritional profile of the tortillas and the presence of soy protein, dietary fibre and bioactive components has the potential to yield other health benefits. It is hypothesized that the addition of soy flour to corn tortillas will lower the glycemic index. The glycemic index describes the potential of a food to increase blood glucose post-prandially in relation to the same amount of available carbohydrate in a glucose solution. Consumption of low glycemic index foods helps to achieve better glycemic control in individuals with type 2 diabetes. Recent meta-analyses are reporting that consumption of high glycemic index foods is associated with higher risk of coronary heart disease and breast cancer in women.

The purpose of this research is to investigate whether different levels of soy flour in corn tortillas influences the glycemic response. This information will form the basis of developing food products for glycemic management in type 2 diabetes and for reducing risk of other chronic diseases.

This single site, double-blind, randomized, controlled study designed to examine the glycemic response to corn and soy tortillas in healthy individuals will recruit 10 eligible volunteers into the study who will visit the research clinic on 6 separate visits for the glycemic testing. At each visit, one of the following products will be consumed: i) 296 mls (~1 cup) of oral glucose solution; ii) 296 mls (~1 cup) of oral glucose solution for a duplicate assessment as per standard glycemic index testing protocols; iii) corn tortillas; iv) corn tortillas with a low amount of soy flour; v) corn tortillas with a moderate amount of soy flour; or vi) corn tortillas made with a higher amount of soy flour.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female, greater or equal to 18 and less than or equal to 40 years of age;
  • Normal blood lipid profile (total cholesterol, LDL-cholesterol, HDL- cholesterol, triglycerides) and glycated hemoglobin <6%;
  • Body mass index (BMI) of 20 to 30;
  • Stable regime for the past 3 months if taking vitamin and mineral/dietary/herbal supplements;
  • Agree not to eat soybeans (edamame) or soy-based foods, or consume soy or isoflavone supplements while participating in this study;
  • Willing to comply with the protocol requirements;
  • Willing to provide informed consent.

Exclusion criteria

  • Allergies to corn or soy flour or to corn or soy products;
  • Presence of a clinically diagnosed disease affecting the circulatory, respiratory, immune, skeletal, urinary, muscular, endocrine, digestive, nervous or reproductive system that requires medical treatment;
  • Taking any prescribed medication (with the exception of birth control) within the last 3 months, or taking supplements which affect glycemic control within the last 3 months;
  • Cigarette/cigar smoking, current or within the last 6 months;
  • Current (within the last 30 days) bacterial, viral or fungal infection, or taking over-the-counter medication within the past 72 h;
  • Pregnancy or lactation.

Treatment and study plan

Oral Glucose Solution 296 mls

Other

Should the participant be eligible to participate, they will be scheduled for two separate study visits to assess the glycemic response of the oral glucose solution.

Corn Tortilla

Other

Should the participant be eligible to participate, they will be scheduled for a study visit to assess the glycemic response of the corn tortillas.

Low Soy Flour Corn Tortilla

Other

Should the participant be eligible to participate, they will be scheduled for a single study visit to assess the glycemic response of corn tortillas with a low amount of soy flour.

Moderate Soy Flour Corn Tortilla

Other

Should the participant be eligible to participate, they will be scheduled for a single study visit to assess the glycemic response of corn tortillas with a moderate amount of soy flour.

High Soy Flour Corn Tortilla

Other

Should the participant be eligible to participate, they will be scheduled for a single study visit to assess the glycemic response of corn tortillas with a high amount of soy flour.

Primary outcomes

  1. Blood glucose as measured via capillary sampling using glucometer

    Time frame: 0, 15, 30, 45, 60, 90 and 120 minutes

    Blood will be sampled via capillary finger prick at time-point 0, (before the product is consumed), and 15, 30, 45, 60, 90 and 120 minutes after the first bite of the tortillas or first sip of the glucose solution to determine blood glucose concentrations using a glucometer.

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Manitoba Pulse Growers

Registry information

Official study title

A Double-Blind, Randomized, Controlled Study to Examine the Glycemic Response of Corn and Soy Tortillas in Healthy Individuals.

Acronym: SOYT-2013

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 11, 2013
Registry last updated
May 15, 2014

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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