Impact of High Milk Product and Calcium Intake During Weight Loss on Markers of Insulin Resistance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Weight loss
研究概览
简要总结
The purpose of this study is to determine if increased intake of low-fat milk products and calcium as part of a calorie restricted diet helps achieve a healthier body weight and body composition and decrease blood glucose levels in people with insulin resistance or type 2 diabetes.
详细描述
Obesity can cause many health problems as it is linked to several chronic diseases including type 2 diabetes. We know that individuals who are overweight or obese, and have impaired glucose tolerance or insulin resistance, have a good chance of developing type 2 diabetes. Research tells us that the risk of developing type 2 diabetes can be decreased by losing weight and making dietary changes. A promising area of study involves using low-fat milk products and calcium to prevent and/or control obesity and diabetes. This study is important because it will determine if including low-fat milk products in weight reducing diets can enhance weight loss, improve fat loss and decrease levels of blood glucose and insulin in individuals with impaired glucose tolerance or type 2 diabetes not treated with medication. This information is directly applicable to treating diseases such as obesity, type 2 diabetes and heart disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overweight and obese (BMI of 27 to 37 kg/m2)
- •Impaired glucose tolerance (fasting blood glucose >5.6 mmol/L) or
- •Type 2 diabetes treated with diet and exercise alone (no medications)
- •One or more of the following criteria for metabolic syndrome:
- •Hypertriglyceridemia (> 1.70 mmol/L)
- •Low high-density lipoprotein (HDL) cholesterol (< 1.04 mmol/L in men and < 1.30 mmol/L in women)
- •High blood pressure (> 130/85 mm Hg)
- •High waist circumference ( > 94 cm in men, > 80 cm in women)
- •Weight stable and no changes in exercise in past 3 months
排除标准
- •Type 1 diabetes
- •Type 2 diabetes treated with oral hypoglycemic agents or insulin
- •HbA1c > 8%
- •myocardial infarction or have undergone a cardiovascular intervention within the past three months
- •Subjects taking fibrate or statins who have had a dose change within the 8 weeks prior to randomization
- •Liver or pancreas disease
- •Major gastrointestinal surgeries
- •Pregnant or lactating
- •Exhibit alcohol or drug dependence
- •Taking drugs influencing appetite
- •Have a milk allergy or lactose intolerance
- •Following a diet or exercise regime designed for weight loss
- •Have a body weight greater than 350 lb (weight limit for DEXA instrument)
- •Chronic use of bulk laxatives, antacids or calcium supplements
结局指标
主要结局
Weight loss
时间窗: 12 weeks
次要结局
- Insulin and glucose response(12 weeks)
- Inflammatory Markers(12 weeks)