Diet, Obesity and Cardiovascular Risk Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2004-01-31

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.

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Detailed Description

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Conditions

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Cardiovascular Diseases Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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LowGI+ModCarb

Low glycemic index + moderate carbohydrate/moderate fat diet

Group Type EXPERIMENTAL

Diet

Intervention Type OTHER

LowGI+HighCarb

Low glycemic index + high carbohydrate/low fat diet

Group Type EXPERIMENTAL

Diet

Intervention Type OTHER

HighGI+ModCarb

High glycemic index + moderate carbohydrate/moderate fat diet

Group Type EXPERIMENTAL

Diet

Intervention Type OTHER

HighGI+HighCarb

High glycemic index + high carbohydrate/low fat diet

Group Type EXPERIMENTAL

Diet

Intervention Type OTHER

Interventions

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Diet

Intervention Type OTHER

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes