Cardiovascular Diseases And Disorders |
Cardiovascular Diseases |
Clinical Trial: Macronutrients and Cardiovascular Risk
This study is not yet open for patient recruitment.
Purpose
To compare the effects on blood pressure and plasma lipids of three different diets--a carbohydrate-rich diet, a protein-rich diet, or a diet rich in unsaturated fat.
| Condition | Treatment or Intervention |
|---|---|
| Cardiovascular Diseases Heart Diseases Atherosclerosis Hypertension | Behavior: Diet therapy |
MedlinePlus related topics: Heart Diseases; Heart Diseases--Prevention; High Blood Pressure; Vascular Diseases
Study Type: Interventional
Study Design: Randomized, Crossover Assignment
Study start: May 2002; Expected completion: March 2007
BACKGROUND: While there is widespread consensus that the optimal diet to reduce cardiovascular risk should be low in saturated fat, the type of macronutrient that should replace saturated fat (carbohydrate, protein or unsaturated fat) is a major, unresolved research question with substantial public health implications. The study will evaluate these three dietary approaches by studying their effects on established coronary risk factors and a selected group of emerging risk factors.
DESIGN NARRATIVE: The study design is a randomized, three period cross-over feeding study that compares the effects on blood pressure and plasma lipids of a carbohydrate-rich diet (the DASH diet) to two other diets, one rich in protein and another rich in unsaturated (UNSAT) fat, predominantly monounsaturated fat. The DASH diet has been shown to reduce blood pressure and LDL-cholesterol substantially, and is currently recommended by policy makers. During a one week run-in, all participants will be fed samples of the three study diets (DASH, PROTEIN and UNSAT). Using a three period cross-over design, participants will then be randomly assigned to the DASH, PROTEIN OR UNSAT diet. Each feeding period will last six weeks; a washout period of at least two weeks will separate each feeding period. Throughout feeding (run-in and the three intervention periods), participants will be fed sufficient calories to maintain their weight. Trial participants (n=160, approximately 50 percent female, approximately 50 percent African-American) will be 20 years of age or older, with systolic blood pressure of 120-159 mmHg and diastolic blood pressure of 80-95 mmHg. Primary outcomes variables will be blood pressure and the established plasma lipid risk factors (LDL-C, HDL-C and triglycerides). Secondary outcomes will include apolipoproteins VLDL-apoB and VLDL-apoCIII, which should be superior to triglycerides as predictors of cardiovascular events, as well as total apolipoprotein B, non-HDL cholesterol, and lipoprotein(a).
Eligibility
Ages Eligible for Study: 20 Years and above, Genders Eligible for Study: Both
Criteria
Location Information
Lawrence Appel, Johns Hopkins University
More Information
Record last reviewed: December 2004
Last Updated: January 10, 2005
Record first received: January 9, 2003
ClinicalTrials.gov Identifier: NCT00051350
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Not Signed In -


