Diet, Obesity and Cardiovascular Risk Study

February 27, 2015 updated by: Susan Roberts, Tufts University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in body weight
Time Frame: Baseline to 12 weeks
Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fasting plasma high density lipoprotein cholesterol
Time Frame: Baseline to 12 weeks, 17 weeks, and 16 months
Baseline to 12 weeks, 17 weeks, and 16 months
Change in fasting plasma low density lipoprotein cholesterol-cholesterol
Time Frame: Baseline to 12 weeks, 17 weeks, and 16 months
Baseline to 12 weeks, 17 weeks, and 16 months
Change in fasting plasma very low density lipoprotein cholesterol-cholesterol
Time Frame: Baseline to 12 weeks, 17 weeks, and 16 months
Baseline to 12 weeks, 17 weeks, and 16 months
Change in fasting plasma triglycerides
Time Frame: Baseline to 12 weeks, 17 weeks, and 16 months
Baseline to 12 weeks, 17 weeks, and 16 months
Change in fasting plasma insulin
Time Frame: Baseline to 12 weeks, 17 weeks, and 16 months
Baseline to 12 weeks, 17 weeks, and 16 months
Change in fasting blood glucose
Time Frame: Baseline to 12 weeks, 17 weeks, and 16 months
Baseline to 12 weeks, 17 weeks, and 16 months
Change in glycated hemoglobin
Time Frame: Baseline to 12 weeks, 17 weeks, and 16 months
Baseline to 12 weeks, 17 weeks, and 16 months
Change in plasma C-reactive protein
Time Frame: Baseline to 12 weeks, 17 weeks, and 16 months
Baseline to 12 weeks, 17 weeks, and 16 months
Change in body fat
Time Frame: Baseline to 12 weeks and 17 weeks
Baseline to 12 weeks and 17 weeks
Change in resting metabolic rate
Time Frame: Baseline to 12 weeks and 17 weeks
Baseline to 12 weeks and 17 weeks
Change in blood pressure
Time Frame: Baseline to 12weeks, 17weeks and 16months
Baseline to 12weeks, 17weeks and 16months
Change in body weight
Time Frame: Baseline to 17weeks and 16months
Baseline to 17weeks and 16months
Change in postprandial blood glucose
Time Frame: Baseline to 12weeks and 17weeks
Oral glucose tolerance test
Baseline to 12weeks and 17weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion (Actual)

January 1, 2004

Study Completion (Actual)

January 1, 2004

Study Registration Dates

First Submitted

February 14, 2015

First Submitted That Met QC Criteria

February 27, 2015

First Posted (Estimate)

March 5, 2015

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

February 27, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01HL 57981

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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