Study of Macronutrients and Heart Disease Risk

Completed · Not applicable

Conditions studied: Obesity, Body Composition, Blood Pressure, Cardiovascular Diseases

In brief

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.

Key facts

Study ID

NCT00609271

Run by

Tulane University Health Sciences Center

People needed

148

Starts

2008-01-01

Expected to finish

2012-01-01

Last updated by the study team

2018-11-19

Who can join

Age: 22 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men or women aged 22 - 75 years, any race/ethnicity
• BMI of 30 - 45 k/m2
• Willing and able to provide informed consent

You may not qualify if…

• History of self-reported clinical CVD (angina/myocardial infarction, coronary revascularization, heart failure, stroke/transient ischemic attack, peripheral arterial disease)
• Medical condition in which a low-carbohydrate diet may not be advised (diabetes, renal disease, cancer requiring treatment during the past year, osteoporosis, untreated thyroid disease, gout)
• Current use of more than 2 antihypertensive or more than 2 cholesterol-lowering medications
• For women, current pregnancy or breastfeeding or plans to become pregnant during the study period
• Consumption of more than 21 alcoholic beverages per week
• Currently on a diet or using prescription weight loss medications, underwent weight loss surgery, and/or experienced weight loss >15 pounds within 6 months of study entry
• Plans to move out of the study area (>1 hour from study site) or difficulty to come to the study site
• Participation of another household member in the study; employees or persons living with employees of the study
• Participation in other lifestyle intervention trials currently
• At the discretion of the study coordinator

Where it is running

• Tulane University, Office of Health Research — New Orleans, Louisiana, United States

Full record on ClinicalTrials.gov

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