Status:
COMPLETED
Study of Macronutrients and Heart Disease Risk
Lead Sponsor:
Tulane University Health Sciences Center
Conditions:
Obesity
Body Composition
Eligibility:
All Genders
22-75 years
Phase:
NA
Brief 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), bo...
Detailed Description
Cardiovascular diseases (CVD) remain the leading cause of death globally as well as here in the United States. Manipulations of the macronutrient (protein, carbohydrate and fat) contents of diet have ...
Eligibility Criteria
Inclusion
- Men or women aged 22 - 75 years, any race/ethnicity
- BMI of 30 - 45 k/m2
- Willing and able to provide informed consent
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00609271
Start Date
January 1 2008
End Date
January 1 2012
Last Update
November 19 2018
Active Locations (1)
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1
Tulane University, Office of Health Research
New Orleans, Louisiana, United States, 70112