A Double-Blind, Randomized, Controlled Study to Examine the Glycemic Response of Corn and Soy Tortillas in Healthy Individuals.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Blood glucose as measured via capillary sampling using glucometer
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Blood glucose as measured via capillary sampling using glucometer
时间窗: 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.
次要结局
未报告次要终点
研究者
Dr. Carla Taylor
Professor and Principal Investigator
University of Manitoba
