Nutritionally complete prepared meal plan to reduce cardiovascular risk factors: A randomized clinical trial

Objective: To compare a nutritionally complete prepared meal plan that meets national dietary guidelines to usual-care dietary therapy for hypertension, dyslipidemia, and glycemic control. Design: Randomized, controlled trial. Subjects/setting: Outpatients with hypertension, dyslipidemia, or diabetes mellitus (n=251) were recruited at 6 medical centers in the United States and Canada. Intervention: The prepared meal plan, which was developed by university-based nutrition and cardiovascular scientists and food technologists at Campbell's Center for Nutrition and Wellness (CCNW), provided the optimal levels of macronutrients and micronutrients recommended for cardiovascular risk reduction in a variety of prepackaged meals and snacks. After a 4-week pretrial period to assess baseline state, participants were randomized to the CCNW plan or 'usual-care' diet for 10 weeks. Main outcome measures: Blood pressure, carbohydrate metabolism, lipoproteins, homocysteine, weight, nutrient intake, compliance. Statistical analyses performed: Repeated measures analysis of variance. Results: Lipoproteins, carbohydrate metabolism, blood pressure, and weight improved on both plans. Mean differences (±standard deviation) between baseline and follow-up for the CCNW plan and the usual-care plan, respectively, were total cholesterol, -0.41±0.64 and -0.20±0.50 mmol/L (between-group P<.01); plasma glucose, -0.7±1.7 and -0.3±1.3 mmol/L (P<.05); systolic blood pressure, -5.2±10.0 and -4.7±9.0 mm Hg (P=.67), diastolic blood pressure, -3.8±5.9 and -2.2±5.5 mm Hg (P<.05); and homocysteine, -1.3±3.8 and 0.2±3.4 μmol/L (P<.01). The CCNW plan led to greater weight loss than the usual-care diet (-5.5±3.8 kg vs -3.0±3.2 kg, P<.0001). Applications/conclusion: The nutritionally complete CCNW plan offers greater improvements in lipids, blood sugars, homocysteine, and weight loss than usual-care diet therapy. This prepackaged comprehensive nutrition program can augment both the prescription and practice of optimal dietary therapy.