OmniHeart Trial: Macronutrients and Cardiovascular Risk
|ClinicalTrials.gov Identifier: NCT00051350|
Recruitment Status : Completed
First Posted : January 13, 2003
Last Update Posted : April 23, 2008
|Condition or disease||Intervention/treatment|
|Cardiovascular Diseases Heart Diseases Atherosclerosis Hypertension||Behavioral: Diet therapy|
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.
The study design was a randomized, three period cross-over feeding study that compared the effects on blood pressure and plasma lipids of a carbohydrate-rich diet patterned after the DASH diet (CARB) to two other diets, one rich in protein (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 were fed samples of the three study diets (CARB, PROTEIN and UNSAT). Using a three period cross-over design, participants were then randomly assigned to the CARB, PROTEIN or UNSAT diet. Each feeding period lasted six weeks; a washout period of at least two weeks separated each feeding period. Throughout feeding (run-in and the three intervention periods), participants were fed sufficient calories to maintain their weight. Trial participants were 30 years of age or older, with systolic blood pressure of 120-159 mmHg or diastolic blood pressure of 90-99 mmHg. Primary outcomes variables were blood pressure and the established plasma lipid risk factors (LDL-C, HDL-C and triglycerides). Secondary outcomes include total cholesterol, apolipoproteins VLDL-apoB, VLDL-apoCIII, apolipoprotein B, non-HDL cholesterol, and lipoprotein(a).
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Crossover Assignment|
|Study Start Date :||May 2002|
|Primary Completion Date :||March 2008|
|Study Completion Date :||March 2008|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051350
|OverallOfficial:||Lawrence Appel||Johns Hopkins University|