An interventional study of Oral Glucose Solution 296 mls and Corn Tortilla in Healthy, sponsored by University of Manitoba. Completed at 1 site in Canada. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-15.
Sponsored by University of Manitoba · Not applicable, Interventional, and Supportive care
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.
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.
University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
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Exclusion Criteria:
Study Participants will consume oral glucose solution 296 mls. Blood will be sampled via capillary at time-point 0 (before the product is consumed), and 15, 30, 45, 60, 90 and 120 minutes after consumption to determine blood glucose concentrations using a glucometer. Per standard glycemic index testing protocols, this will be repeated at another visit.
Other: Corn Tortilla · Other: Low Soy Flour Corn Tortilla · Other: Moderate Soy Flour Corn Tortilla · Other: High Soy Flour Corn Tortilla
Study Participants will consume 2 to 3.5 corn tortillas (12-15 cm in diameter each) with a total serving of 25 grams of available carbohydrate. Blood will be sampled via capillary at time-point 0 (before the product is consumed), and 15, 30, 45, 60, 90 and 120 minutes after consumption to determine blood glucose concentrations using a glucometer.
Other: Oral Glucose Solution 296 mls
Study Participants will consume 2 to 3.5 tortillas (12-15 cm in diameter each) with a low amount of soy flour that is 25 grams of available carbohydrate. Blood will be sampled via capillary at time-point 0 (before the product is consumed), and 15, 30, 45, 60, 90 and 120 minutes after consumption to determine blood glucose concentrations using a glucometer.
Other: Oral Glucose Solution 296 mls
Study Participants will consume 2 to 3.5 tortillas (12-15 cm in diameter each) with moderate amount of soy flour that has 25 grams of available carbohydrate. Blood will be sampled via capillary at time-point 0 (before the product is consumed), and 15, 30, 45, 60, 90 and 120 minutes after consumption to determine blood glucose concentrations using a glucometer.
Other: Oral Glucose Solution 296 mls
Study Participants will consume 2 to 3.5 tortillas (12-15 cm in diameter each) with a high amount soy flour that has 25 grams of available carbohydrate. Blood will be sampled via capillary at time-point 0 (before the product is consumed), and 15, 30, 45, 60, 90 and 120 minutes after consumption to determine blood glucose concentrations using a glucometer.
Other: Oral Glucose Solution 296 mls
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.
Should the participant be eligible to participate, they will be scheduled for a study visit to assess the glycemic response of the corn tortillas.
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.
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.
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.
Blood glucose as measured via capillary sampling using glucometer
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.
Time frame: 0, 15, 30, 45, 60, 90 and 120 minutes
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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University of Manitoba