Diet, Obesity and Cardiovascular Risk Study

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Obesity
• Interventions: Other: Diet

• 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

Study Timeline

• Study Start: 2000-09
• Primary Completion: 2004-01
• Study Completion: 2004-01
• Status Verified: 2015-02
• Study First Submitted: 2015-02-14
• Study First Submitted QC: 2015-02-27
• Last Update Submitted: 2015-02-27
• Study First Posted: 2015-03-05
• Last Update Posted: 2015-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• BMI 28-28 kg/m2
• Male or postmenopausal female 45-65 yr

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LowGI+HighCarb	Diet	Low glycemic index + high carbohydrate/low fat diet
LowGI+ModCarb	Diet	Low glycemic index + moderate carbohydrate/moderate fat diet
HighGI+ModCarb	Diet	High glycemic index + moderate carbohydrate/moderate fat diet
HighGI+HighCarb	Diet	High glycemic index + high carbohydrate/low fat diet

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