Lentils as a Functional Food to Improve Glucose Tolerance and Decrease Cardiovascular Disease Risk in Hypercholesterolemic Overweight Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 4
- 主要终点
- To examine the effect of lentils on glucose tolerance and LDL-cholesterol.
研究概览
简要总结
Compared to control foods, consumption of 3 cups of cooked lentils given weekly for 12 weeks will significantly improve glucose tolerance and lower LDL-cholesterol in individuals with high cholesterol and obesity.
详细描述
This is a multi-site, randomized, controlled, parallel group food study designed to examine the health benefits, specifically glucose tolerance, insulin sensitivity and LDL-cholesterol in overweight individuals with a high waist circumference and elevated LDL-cholesterol. Recruitment will consist of approximately 102 overweight participants (n= 51 participants per site, at 2 sites located in Winnipeg and Toronto) with high waist circumference and elevated LDL-cholesterol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant, non-lactating females aged 30 to 75 years;
- •Body Mass Index of ≤40 kg/m2 and ≥23 kg/m2 if Asian or ≥25 kg/m2 if non-Asian;
- •Waist circumference ≥94 cm for males and ≥80 cm for females of Asian ethnicity,and ≥102 cm for males and ≥88 cm of non-Asian ethnicity;
- •Fasting plasma glucose <7 mmol/L;
- •Fasting triglycerides <4.00 mmol/L and LDL-cholesterol >2.50 mmol/L and <5.00 mmol/L;
- •Must be on a stable regime for the past 3 months if taking medications to treat hypertension or if taking vitamin and mineral/dietary/herbal supplements;
- •Stable body weight (±3 kg) for the past 3 months
排除标准
- •Previous diagnosis of type 2 diabetes;
- •High pulse consumption (≥2 servings per week);
- •Presence of liver disease (aspartate transaminase >2 times Upper Normal Limit), renal insufficiency (creatinine >1.5 times Upper Normal Limit); inflammatory bowel disease or other gastrointestinal disorders influencing gastrointestinal motility or nutrient absorption;
- •Use of medication which influence carbohydrate metabolism (i.e., steroids), or medications used to treat diabetes or to lower blood lipids, or any active medical or surgical conditions within the past 3 months;
- •Conditions or medications which are likely to increase the risk to the participants or study personnel, or to reduce the ability of the participant to comply with the protocol, or affect the results;
- •History of gastrointestinal reactions or allergies to lentils or potato-based foods, or to one or more ingredients in the study foods which significantly limits the number of study foods that can be consumed.
结局指标
主要结局
To examine the effect of lentils on glucose tolerance and LDL-cholesterol.
时间窗: 12 weeks
次要结局
- To examine the effect of lentils on glycated hemoglobin; fasting plasma glucose, insulin, triglycerides, HDL-cholesterol and C-reactive protein.(12 weeks)
研究者
Dr. Carla Taylor
Professor, Department of Human Nutritional Sciences
University of Manitoba