NUTRITIONAL MANAGEMENT OF CARDIOVASCULAR RISK-FACTORS - A RANDOMIZED CLINICAL-TRIAL

Background: Adherence to dietary recommendations for disease managemen t is often hindered by the complexity of incorporating them into the d aily diet. Nutrition and cardiovascular scientists and food technologi sts collaborated to develop a prepared meal plan that meets national d ietary guidelines for cardiovascular risk reduction. Objective: To ass ess the clinical effects of this plan, which incorporates all National Academy of Sciences National Research Council recommended dietary all owances for vitamins, minerals, and macronutrients, compared with a pa tient-selected American Heart Association Step I and Step II diet plan . Methods: This multicenter, randomized, parallel intervention trial w as conducted at 10 medical centers in the United States and Canada and involved 560 men and women with hypertension, dyslipidemia, or diabet es. Following calculation of prescriptions to meet individual nutritio nal requirements based on the Harris-Benedict equation, participants w ere randomized to the Campbell's Center for Nutrition and Wellness (CC NW) plan, which is composed of prepackaged breakfast, lunch, and dinne r meals provided to participants, or a nutritionist-guided American He art Association Step I and Step II diet, in which participants self-se lected foods to meet their nutrition prescription for 10 weeks. Main O utcome Measures: Blood pressure (BP); lipid, glucose, glycosylated hem oglobin (HbA(1c)), and insulin levels; body weight; dietary intake; an d quality of life. Results: Patients' BP, lipid levels, carbohydrate m etabolism, weight, and quality of life (P less than or equal to.001 fo r all findings except low-density lipoprotein-high-density lipoprotein ratio, P=.25) all improved on both nutrition plans. Mean differences (+/-SD) between baseline and treatment clinical values for the CCNW an d the self-selected diet groups (between-group P values), respectively , were as follows: systolic BP, -6.4+/-9.2 mm Hg and -4.6+/-9.0 mm Hg (P=.02); diastolic BP, -4.2+/-5.7 mm Hg and -3.0+/-5.1 mm Hg (P=.006); cholesterol, -0.32+/-0.58 mmol/L and -0.27+/-0.56 mmol/L (-12.4+/-22. 5 mg/dL and -10.4+/-21.9 mg/dL) (P=.30); glucose, -0.65+/-1.88 mmol/L and -0.75+/-2.03 mmol/L (-11.7+/-34.0 mg/dL and -13.5+/-36.6 mg/dL) (P =.10); and HbA(1c), -0.4%+/-0.8% and -0.3%+/-0.7% (P=.66). Weight loss with the CCNW and self-selected plans, respectively, was as follows: men, -4.5+/-3.6 kg and -3.5+/-3.3 kg; and women, -4.8+/-3.0 kg and -2. 8+/-2.8 kg. Quality of life was significantly improved for daily and w ork activities (P<.05) and nutritional health perceptions (P<.05) with the CCNW plan relative to the self-selected group. Overall nutrient i ntake and compliance were both significantly (P<.001) better with the CCNW plan. Conclusions: Nutritionally balanced meals that meet the rec ommendations of national health organizations improved multiple risk f actors for patients with cardiovascular disease. The CCNW plan resulte d in greater clinical benefits, nutritional completeness, and complian ce than the self-selected diet. The CCNW is a comprehensive nutrition plan, convenient for both prescription and practice, and appears viabl e for effecting favorable dietary changes in patients at high risk for cardiovascular disease.