The Effects of Increased Dietary Protein Intake on Insulin Sensitivity in Stable Weight Individuals, Independent of Dietary Content of Carbohydrate and Saturated Fat
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 660
- 试验地点
- 4
- 主要终点
- HDL Cholesterol
研究概览
简要总结
The overall objective of the Dietary Protein and Insulin Sensitivity Study is to test the hypothesis that increased protein in a diet with reduced carbohydrate (35% energy) can ameliorate insulin resistance in the absence of weight loss, and that this effect is independent of saturated fat content. Moreover, we will test whether such diets result in beneficial changes in total LDL cholesterol, small, dense LDL, and HDL cholesterol that are also independent of saturated fat intake.
详细描述
Insulin resistance is a major metabolic disturbance associated with excess adiposity that contributes to atherogenic dyslipidemia and predisposes to both cardiovascular disease and type 2 diabetes mellitus. The effects on insulin resistance of changes in dietary macronutrient composition in the absence of weight loss are poorly understood. To better understand these effects, we will study men and women with insulin resistance after 4 weeks on a basal diet (15% protein, 55% carbohydrate, 30% fat) and 4 weeks after random assignment to the basal diet or one of 4 diets with 35% carbohydrate and either 20% or 30% protein, and either 7% or 15% saturated fat. At the end of each dietary period (4 weeks and 8 weeks), we will draw a blood sample for detailed metabolic measurements and measure insulin sensitivity by the frequently sampled intravenous glucose tolerance test (FSIGT) method. In addition to insulin resistance, we will assess the effect of dietary composition on parameters of atherogenic dyslipidemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) ≥ 27 and ≤ 40 kg/m2
- •HOMA-IR ≥ 2.5
- •Non-smoking
- •Total cholesterol and LDL cholesterol <95th percentile for sex and age
- •Fasting triglycerides < 500mg/dl
- •Fasting blood sugar < 126
- •Urinary microalbumin < 30 mg/L
- •Normal thyroid stimulating hormone levels
- •Hematocrit ≥ 36%
- •Blood pressure < 150/90
- •At least 3 months of a weight-stable state (± 5 lbs) prior to the study. During the study, subjects will be required to maintain their body weight within ± 3% (up to a maximum change of 5 lbs) of their initial weight over the course of any consecutive two weeks after the second week of baseline diet or during the last week of each diet phase
排除标准
- •History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, HIV, or cancer (other than skin cancer) in the last 5 years
- •Use of drugs known to affect lipid metabolism or insulin resistance, hormones, or the blood thinning agent, warfarin
- •Use of alcohol or dietary supplements during the study
- •Pregnancy
结局指标
主要结局
HDL Cholesterol
时间窗: 4wks and 8wks
LDL subclasses
时间窗: 4wks and 8wks
Total Cholesterol
时间窗: 4wks and 8wks
Triglycerides
时间窗: 4wks and 8wks
LDL peak particle size
时间窗: 4wks and 8wks
LDL Cholesterol
时间窗: 4wks and 8wks
Insulin Sensitivity by Frequently Sampled Intravenous Glucose Tolerance test
时间窗: 4wks and 8wks
次要结局
- Apolipoprotein B(4wks and 8wks)
- Apolipoprotein A1(4wks and 8wks)