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 proposed study will evaluate these 3 dietary approaches by studying their effects on established coronary risk factors and a selected group of emerging risk factors. The study design is a randomized, three period cross-over feeding study that will compare 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 1 week run- in, all participants will be fed samples of the 3 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 6 weeks; a washout period of at least 2 weeks will separate each feeding period. Throughout feeding (run-in and the 3 intervention periods), participants will be fed sufficient calories to maintain their weight. Trial participants (n=200, 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). In this fashion, the trial should advance our fundamental knowledge of the effects of diet on both traditional and emerging risk factors, and in the process, inform policy makers and health care providers on the relative benefits of carbohydrate, protein and unsaturated fat, predominantly monounsaturated fat, as means to reduce cardiovascular risk.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
5R01HL067098-05
Application #
7033061
Study Section
Nutrition Study Section (NTN)
Program Officer
Loria, Catherine
Project Start
2002-05-25
Project End
2009-03-31
Budget Start
2006-04-01
Budget End
2009-03-31
Support Year
5
Fiscal Year
2006
Total Cost
$1,125,377
Indirect Cost
Name
Johns Hopkins University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
Haring, Bernhard; von Ballmoos, Moritz C Wyler; Appel, Lawrence J et al. (2014) Healthy dietary interventions and lipoprotein (a) plasma levels: results from the Omni Heart Trial. PLoS One 9:e114859
Gadgil, Meghana D; Appel, Lawrence J; Yeung, Edwina et al. (2013) The effects of carbohydrate, unsaturated fat, and protein intake on measures of insulin sensitivity: results from the OmniHeart trial. Diabetes Care 36:1132-7
Furtado, Jeremy D; Campos, Hannia; Sumner, Anne E et al. (2010) Dietary interventions that lower lipoproteins containing apolipoprotein C-III are more effective in whites than in blacks: results of the OmniHeart trial. Am J Clin Nutr 92:714-22
Yeung, Edwina H; Appel, Lawrence J; Miller 3rd, Edgar R et al. (2010) The effects of macronutrient intake on total and high-molecular weight adiponectin: results from the OMNI-Heart trial. Obesity (Silver Spring) 18:1632-7
Beasley, Jeannette M; Ange, Brett A; Anderson, Cheryl A M et al. (2009) Characteristics associated with fasting appetite hormones (obestatin, ghrelin, and leptin). Obesity (Silver Spring) 17:349-54
Beasley, Jeannette M; Ange, Brett A; Anderson, Cheryl A M et al. (2009) Associations between macronutrient intake and self-reported appetite and fasting levels of appetite hormones: results from the Optimal Macronutrient Intake Trial to Prevent Heart Disease. Am J Epidemiol 169:893-900
de Souza, Russell J; Swain, Janis F; Appel, Lawrence J et al. (2008) Alternatives for macronutrient intake and chronic disease: a comparison of the OmniHeart diets with popular diets and with dietary recommendations. Am J Clin Nutr 88:1-11
Swain, Janis F; McCarron, Phyllis B; Hamilton, Eileen F et al. (2008) Characteristics of the diet patterns tested in the optimal macronutrient intake trial to prevent heart disease (OmniHeart): options for a heart-healthy diet. J Am Diet Assoc 108:257-65
Furtado, Jeremy D; Campos, Hannia; Appel, Lawrence J et al. (2008) Effect of protein, unsaturated fat, and carbohydrate intakes on plasma apolipoprotein B and VLDL and LDL containing apolipoprotein C-III: results from the OmniHeart Trial. Am J Clin Nutr 87:1623-30
Carey, Vincent J; Bishop, Louise; Charleston, Jeanne et al. (2005) Rationale and design of the Optimal Macro-Nutrient Intake Heart Trial to Prevent Heart Disease (OMNI-Heart). Clin Trials 2:529-37

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