This Article Full Text (PDF) References Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Carey, V. J Articles by Appel, L. J Search for Related Content PubMed PubMed Citation Articles by Carey, V. J Articles by Appel, L. J Pubmed/NCBI databases Substance via MeSH Medline Plus Health Information Cholesterol Clinical Trials Diets Heart Disease in Women Heart Diseases High Blood Pressure Social Bookmarking                         What's this?

Rationale and design of the Optimal Macro-Nutrient Intake Heart Trial to Prevent Heart Disease (OMNI-Heart)

Channing Laboratory, Harvard Medical School, 181 Longwood Avenue, Boston, MA 02115, USA vincent.carey{at}channing.harvard.edu

Louise Bishop

Brigham and Women's Hospital, Boston, MA, USA

Jeanne Charleston

Johns Hopkins University Bloomberg School of Public Health, 1849 Gwynn Oak Avenue Suite 1, Baltimore, MD, USA

Paul Conlin

Brigham and Women's Hospital, Boston, MA, USA

Tate Erlinger

Welch Center for Prevention, Epidemiology and International Health, Johns Hopkins University, Baltimore, MD, USA

Nancy Laranjo

Channing Laboratory, Harvard Medical School, Boston, MA, USA

Phyllis McCarron

Johns Hopkins University School of Medicine, Baltimore, MD, USA

Edgar Miller

Welch Center for Prevention, Epidemiology and International Health, Johns Hopkins University, Baltimore, MD, USA

Bernard Rosner

Channing Laboratory, Harvard Medical School, Boston, MA, USA

Janis Swain

Brigham and Women's Hospital, Boston, MA, USA

Frank M Sacks

Dept of Nutrition, Harvard School of Public Health, Boston, MA, USA

Lawrence J Appel

Welch Center for Prevention, Epidemiology and International Health, Johns Hopkins University, Baltimore, MD, USA

Background The DASH (Dietary Approaches to Stop Hypertension) diet is a carbohydrate-rich, reduced-fat diet that lowers blood pressure (BP) and LDL-cholesterol. Whether partial replacement of some carbohydrate (C) with either protein (P) or unsaturated fat (U) can further improve these and other cardiovascular (CVD) risk factors is unknown.

Methods OmniHeart is a randomized, three-period, crossover feeding study designed to compare the effects on BP and blood lipids of a carbohydrate-rich diet (CARB, similar to the DASH diet) with a diet rich in protein (PROT, predominantly from nonmeat sources) and a diet rich in unsaturated fat (UNSAT, predominantly monounsaturated). Throughout feeding (run in and the three intervention periods), participants are provided with all of their meals that meet the nutrient profile of their assigned diet. Calorie intake is adjusted to maintain weight. The target sample size is 160 (50% African-American). Participants are adults, aged 30 or older, with prehypertension or Stage 1 hypertension (systolic BP 120–159 or diastolic BP 80–99 mmHg). The primary outcome variables are systolic BP and LDL-cholesterol. Secondary outcomes are diastolic BP, HDL-cholesterol, and triglycerides. Other outcome variables are total cholesterol, apolipoproteins VLDL-apoB, VLDL-apoCIII, apolipoprotein B, non-HDL cholesterol, and lipoprotein(a), and insulin resistance, as measured by Homeostasis Model Assessment (HOMA).

Conclusions OMNI-Heart should advance our fundamental knowledge of the effects of diet on both traditional and emerging risk factors, and, in the process, guide policy makers, health care providers and the general public on the relative benefits of carbohydrate, protein, and unsaturated fat as a means to reduce CVD risk.

Clinical Trials, Vol. 2, No. 6, 529-537 (2005)
DOI: 10.1191/1740774505cn123oa


CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				J. M. Beasley, B. A. Ange, C. A. M. Anderson, E. R. Miller III, T. P. Erlinger, J. T. Holbrook, F. M. Sacks, and L. J. Appel 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., April 1, 2009; 169(7): 893 - 900. [Abstract] [Full Text] [PDF]