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 m ellitus (n=251) were recruited at 6 medical centers in the United States an d Canada. Intervention The prepared meal plan, which was developed by university-base d nutrition and cardiovascular scientists and food technologists at Campbel l's Center for Nutrition & Wellness (CCNW), provided the optimal levels of macronutrients and micronutrients recommended for cardiovascular risk reduc tion in a variety of prepackaged meals and snacks. After a 4-week pretrial period to assess baseline state, participants were randomized to the CCNW p lan 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 i mproved on both plans. Mean differences (+/-standard deviation) between bas eline 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-gro up P<.01); plasma glucose, -0.7+/-1.7 and -0.3+/-1.3 mmol/L (P<.05); systol ic blood pressure, -5.2+/-10.0 and -4.7+/-9.0 mm Hg (P=.67), diastolic bloo d 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 u sual-care diet therapy. This prepackaged comprehensive nutrition program ca n augment both the prescription and practice of optimal dietary therapy.