Diet is the cornerstone of therapy for hypertension, dyslipidemia and diabetes mellitus; these dietary modifications include reduced intake of total and saturated fat, cholesterol, sodium and refined sugars, and attaining adequate intakes of minerals, vitamins, fiber and complex carbohydrates. Unfortunately, it is difficult for many people to change their diets. Thus, non-compliance with therapeutic dietary regimens remains a major obstacle in achieving improvements in cardiovascular disease (CVD) morbidity and mortality. The difficulties in complying with dietary recommendations come from a number of areas. Understanding, planning and implementing diets that meet the guidelines recommended for the control of diet responsive chronic diseases is a complex task that requires considerable effort on the patient's part. To meet the guidelines, patients must calculate the nutrient content of the foods they eat, select a balance of foods that provide the right combination of nutrients, determine appropriate portion sizes, and then prepare the food in specific ways. To address the challenge of implementing the diverse dietary recommendations commonly prescribed for patients at increased risk of cardiovascular disease, the principles of nutrition science and procedures of food technology were combined to develop a balanced and convenient total nutrition food program. Three short term clinical trials were performed to test the acceptability and effectiveness of this program These clinical trials demonstrated that it is feasible for free-living individuals to follow (for a short time) a food plan that provides essentially all the RDA's of the National Academy of Sciences while meeting the nutritional recommendations for cardiovascular risk reduction of major U.S. health organizations. This intervention, although of limited duration, resulted in improvements in multiple cardiovascular risk factors including hypertension, hyperlipidemia, hyperinsulinemia and body weight. The purpose of the current study is to test the acceptability and effectiveness of this program in a long term clinical trial. This study is designed to: measure the acceptability of following a long-term Meal Program and determine the difference between two dietary intervention groups that follow a therapeutically prescribed meal program over 52 weeks by either the usual care therapeutic diet or a Meal Program. The variables to be studies include: body weight, blood pressure, plasma lipids, insulin, hemoglobin A1C, vitamin levels, urine electrolytes, serum iron and ferritin, quality of life, diet satisfaction, and compliance with diet.
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