Diet, Obesity and Cardiovascular Risk Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 主要终点
- Change in body weight
研究概览
简要总结
Controversy exists about the role of dietary glycemic index (GI) and fat content and cardiovascular risk. Our aim was to assess the long term effects of altering dietary GI, carbohydrate, and fat on body weight, lipids, glucose homeostasis, and C reactive protein (CRP) in overweight and obese subjects. Men and post-menopausal women with body mass index values between 28-38 kg/m2 were placed on an isoweight average American diet for 5 weeks, then randomized to one of 4 diets which differed in GI, carbohydrate and fat content with calorie restriction for 12 weeks. The same diets were continued for 5 weeks under isoweight conditions, and in the free-living state for 48 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 28-28 kg/m2
- •Male or postmenopausal female 45-65 yr
排除标准
- •Abnormal thyroid, liver, kidney function
- •Abnormal hemoglobin
- •LDL-cholesterol ≤ 100 mg/dL
- •Fasting triglycerides ≥ 400 mg/dL
- •Diabetes or on medication for diabetes
- •Chronic illness
- •Elevated blood lipids
结局指标
主要结局
Change in body weight
时间窗: Baseline to 12 weeks
次要结局
- Change in fasting plasma high density lipoprotein cholesterol(Baseline to 12 weeks, 17 weeks, and 16 months)
- Change in fasting plasma very low density lipoprotein cholesterol-cholesterol(Baseline to 12 weeks, 17 weeks, and 16 months)
- Change in plasma C-reactive protein(Baseline to 12 weeks, 17 weeks, and 16 months)
- Change in body fat(Baseline to 12 weeks and 17 weeks)
- Change in resting metabolic rate(Baseline to 12 weeks and 17 weeks)
- Change in body weight(Baseline to 17weeks and 16months)
- Change in postprandial blood glucose(Baseline to 12weeks and 17weeks)
- Change in fasting plasma low density lipoprotein cholesterol-cholesterol(Baseline to 12 weeks, 17 weeks, and 16 months)
- Change in fasting plasma triglycerides(Baseline to 12 weeks, 17 weeks, and 16 months)
- Change in glycated hemoglobin(Baseline to 12 weeks, 17 weeks, and 16 months)
- Change in fasting plasma insulin(Baseline to 12 weeks, 17 weeks, and 16 months)
- Change in fasting blood glucose(Baseline to 12 weeks, 17 weeks, and 16 months)
- Change in blood pressure(Baseline to 12weeks, 17weeks and 16months)
研究者
Susan Roberts
Senior Scientist
Tufts University