A Double-Blind, Randomized, Controlled Study to Examine the Glycemic Response of Barley Tortillas in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Calculation of area under the curve for glucose and insulin
研究概览
简要总结
The variation in starch and fibre composition of prepared barley tortillas will have a significant effect on glycemic response.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, 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 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
排除标准
- •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
研究组 & 干预措施
tortilla with high amylose flour
干预措施: food product (Dietary Supplement)
barley tortilla with low amylose flour
干预措施: food product (Dietary Supplement)
barley tortilla with low amylose flour and soluble fibre
干预措施: food product (Dietary Supplement)
barley tortilla with low amylose flour and insoluble fibre
干预措施: food product (Dietary Supplement)
glucose
干预措施: food product (Dietary Supplement)
barley tortilla with low amylose flour and low soluble fibre
干预措施: food product (Dietary Supplement)
结局指标
主要结局
Calculation of area under the curve for glucose and insulin
时间窗: 6 weeks
次要结局
- comparison of food groups using ANOVA(6 weeks)
- measurement of incretins(6 weeks)