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 & 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 mu mol/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.