Diet, Obesity and Cardiovascular Risk Study

Study Overview
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Brief Summary
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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.

Official Title
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Diet, Obesity and Cardiovascular Risk Study

Conditions
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Obesity, Cardiovascular Diseases

Intervention / Treatment
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* Other: Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 28-28 kg/m2 Male or postmenopausal female 45-65 yr Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LowGI+ModCarb<br>Low glycemic index + moderate carbohydrate/moderate fat diet | Other: Diet<br> <br> |
| Experimental: LowGI+HighCarb<br>Low glycemic index + high carbohydrate/low fat diet | Other: Diet<br> <br> |
| Experimental: HighGI+ModCarb<br>High glycemic index + moderate carbohydrate/moderate fat diet | Other: Diet<br> <br> |
| Experimental: HighGI+HighCarb<br>High glycemic index + high carbohydrate/low fat diet | Other: Diet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight |  | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting plasma high density lipoprotein cholesterol |  | Baseline to 12 weeks, 17 weeks, and 16 months | 
| Change in fasting plasma low density lipoprotein cholesterol-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 fasting plasma triglycerides |  | 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 glycated hemoglobin |  | 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 blood pressure |  | Baseline to 12weeks, 17weeks and 16months | 
| Change in body weight |  | Baseline to 17weeks and 16months | 
| Change in postprandial blood glucose | Oral glucose tolerance test | Baseline to 12weeks and 17weeks |