Diet, Obesity and Cardiovascular Risk Study
- Conditions
- Cardiovascular DiseasesObesity
- Registration Number
- NCT02379897
- Lead Sponsor
- Tufts University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 107
- BMI 28-28 kg/m2
- Male or postmenopausal female 45-65 yr
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in body weight Baseline to 12 weeks
- Secondary Outcome Measures
Name Time Method 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 Oral glucose tolerance test
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
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