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Results of the OmniHeart Randomized Trial

Lawrence J. Appel, MD, MPH; Frank M. Sacks, MD; Vincent J. Carey, PhD; Eva Obarzanek, PhD; Janis F. Swain, MS, RD; Edgar R. Miller III, MD, PhD; Paul R. Conlin, MD; Thomas P. Erlinger, MD, MPH; Bernard A. Rosner, PhD; Nancy M. Laranjo; Jeanne Charleston, RN; Phyllis McCarron, MS, RD; Louise M. Bishop, RD; for the OmniHeart Collaborative Research Group

JAMA. 2005;294:2455-2464.

Context  Reduced intake of saturated fat is widely recommended for prevention of cardiovascular disease. The type of macronutrient that should replace saturated fat remains uncertain.

Objective  To compare the effects of 3 healthful diets, each with reduced saturated fat intake, on blood pressure and serum lipids.

Design, Setting, and Participants  Randomized, 3-period, crossover feeding study (April 2003 to June 2005) conducted in Baltimore, Md, and Boston, Mass. Participants were 164 adults with prehypertension or stage 1 hypertension. Each feeding period lasted 6 weeks and body weight was kept constant.

Interventions  A diet rich in carbohydrates; a diet rich in protein, about half from plant sources; and a diet rich in unsaturated fat, predominantly monounsaturated fat.

Main Outcome Measures  Systolic blood pressure and low-density lipoprotein cholesterol.

Results  Blood pressure, low-density lipoprotein cholesterol, and estimated coronary heart disease risk were lower on each diet compared with baseline. Compared with the carbohydrate diet, the protein diet further decreased mean systolic blood pressure by 1.4 mm Hg (P = .002) and by 3.5 mm Hg (P = .006) among those with hypertension and decreased low-density lipoprotein cholesterol by 3.3 mg/dL (0.09 mmol/L; P = .01), high-density lipoprotein cholesterol by 1.3 mg/dL (0.03 mmol/L; P = .02), and triglycerides by 15.7 mg/dL (0.18 mmol/L; P<.001). Compared with the carbohydrate diet, the unsaturated fat diet decreased systolic blood pressure by 1.3 mm Hg (P = .005) and by 2.9 mm Hg among those with hypertension (P = .02), had no significant effect on low-density lipoprotein cholesterol, increased high-density lipoprotein cholesterol by 1.1 mg/dL (0.03 mmol/L; P = .03), and lowered triglycerides by 9.6 mg/dL (0.11 mmol/L; P = .02). Compared with the carbohydrate diet, estimated 10-year coronary heart disease risk was lower and similar on the protein and unsaturated fat diets.

Conclusion  In the setting of a healthful diet, partial substitution of carbohydrate with either protein or monounsaturated fat can further lower blood pressure, improve lipid levels, and reduce estimated cardiovascular risk.

Clinical Trials Registration  ClinicalTrials.gov Identifier: NCT00051350.

Author Affiliations: Welch Center for Prevention, Epidemiology and Clinical Research (Drs Appel, Miller, and Erlinger and Ms Charleston), Division of General Internal Medicine (Drs Appel, Miller, and Erlinger and Ms McCarron), and Department of Epidemiology (Drs Appel, Miller, and Erlinger and Ms Charleston), Johns Hopkins University School of Medicine and the Bloomberg School of Public Health, Baltimore, Md; Channing Laboratory (Drs Carey and Rosner and Mss Laranjo and Swain), Division of Endocrinology, Diabetes and Hypertension (Dr Conlin), and the General Clinical Research Center (Ms Swain), Brigham and Women’s Hospital and Harvard Medical School, Boston, Mass; Nutrition Department (Dr Sacks and Ms Bishop), Harvard School of Public Health, Boston, Mass; Division of Epidemiology and Clinical Applications, National Heart, Lung, and Blood Institute, Bethesda, Md (Dr Obarzanek); Endocrinology Division, VA Boston Healthcare System; Harvard Medical School, Boston, Mass (Dr Conlin).

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