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Study of Macronutrients and Heart Disease Risk

NCT00609271 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2018-11-19

Study results available
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Summary

The objective of this trial is to examine the long-term effects of a diet low in carbohydrates, as compared to one low in fat, on cardiovascular disease risk factors, including blood pressure (BP), body weight and composition, serum lipids, plasma glucose, insulin, adipocytokines (adiponectin, leptin, resistin), and C-reactive protein (CRP) among obese adults.

The investigators will test the following hypotheses:

Hypothesis 1: Compared to a low fat diet, a diet low in carbohydrates will reduce systolic and diastolic BP over 12 months; Hypothesis 2: Compared to a low fat diet, a diet low in carbohydrates will reduce body weight, total percent body fat, and waist circumference over 12 months; Hypothesis 3: Compared to a low fat diet, a diet low in carbohydrates will reduce serum levels of LDL-cholesterol and triglycerides and increase serum levels of HDL-cholesterol over 12 months; Hypothesis 4: Compared to a low fat diet, a diet low in carbohydrates will reduce plasma levels of glucose and insulin levels over 12 months; and Hypothesis 5: Compared to a low fat diet, a diet low in carbohydrates will reduce plasma levels of leptin, resistin, and CRP and increase plasma levels of adiponectin over 12 months.

Conditions

Interventions

BEHAVIORAL

low carbohydrate diet

\<40 grams carbohydrate/day

BEHAVIORAL

low fat diet

\<30% fat, \<7% saturated fat

Sponsors & Collaborators

  • Tulane University Health Sciences Center

    lead OTHER

Principal Investigators

  • Lydia A Bazzano, MD, PhD · Tulane University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2011-01-31
Completion
2012-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00609271 on ClinicalTrials.gov