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6% at 2 years. (ClinicalTrials. Participants Our goal was to recruit 800 overweight and obese subjects (400 at each site), of whom about 40% would be men. gov number, NCT00072995. The participants were offered group and individual instructional sessions for 2 years. The crucial question is whether overweight people have a better response in the long term to diets that emphasize a specific macronutrient composition. The diets consisted of similar foods and met guidelines for cardiovascular health. The more favorable effects on lipids (with the low-carbohydrate diet) and on glycemic control (with the Mediterranean diet) suggest that personal preferences and metabolic considerations might inform individualized tailoring of dietary interventions. Conclusions Reduced-calorie diets result in clinically meaningful weight loss regardless of which macronutrients they emphasize. ) Full Text of Discussion. Methods Eligibility and Study Design We conducted the trial between July 2005 and June 2007 in Dimona, Israel, in a workplace at a research center with an on-site medical clinic. The primary outcome was the change in body weight after 2 years in two-by-two factorial comparisons of low fat versus high fat and average protein versus high protein and in the comparison of highest and lowest carbohydrate content. ) Full Text of Discussion. The project staff of the National Heart, Lung, and Blood Institute also participated in the development of the protocol, monitoring of progress, interpretation of results, and critical review of the manuscript. Media in This Article Figure 1 Enrollment of the Participants and Completion of the Study.
Conclusions Mediterranean and low-carbohydrate diets may be effective alternatives to low-fat diets. Media in This Article Poll Results Contributors Figure 1 Mean Change in Body Weight and Waist Circumference from Baseline to 2 Years According to Dietary Macronutrient Content. Abstract Background The possible advantage for weight loss of a diet that emphasizes protein, fat, or carbohydrates has not been established, and there are few studies that extend beyond 1 year. Figure 2 Weight Changes during 2 Years According to Diet Group. Abstract Background Trials comparing the effectiveness and safety of weight-loss diets are frequently limited by short follow-up times and high dropout rates. (ClinicalTrials. The diets improved lipid-related risk factors and fasting insulin levels. Thus, we recognized the need for a large trial that would be designed to overcome the limitations of previous trials and that would compare the effects of three principal dietary macronutrients. The criteria for eligibility were an age of 40 to 65 years and a body-mass index (BMI, the weight in kilograms divided by the square of the height in meters) of at least 27, or the presence of type 2 diabetes (according to the American Diabetes Association criteria 18 ) or coronary heart disease, regardless of age and BMI. gov number, NCT00160108. The Mediterranean-diet group consumed the largest amounts of dietary fiber and had the highest ratio of monounsaturated to saturated fat (P Full Text of Results. Participants had to be 30 to 70 years of age and have a body-mass index (the weight in kilograms divided by the square of the height in meters) of 25 to 40. The participants were randomly assigned within strata of sex, age (below or above the median), BMI (below or above the median), history of coronary heart disease (yes or no), history of type 2 diabetes (yes or no), and current use of statins (none, The members of each of the three diet groups were assigned to subgroups of 17 to 19 participants, with six subgroups for each group. Figure 2 Mean Changes in Body Weight and Waist Circumference at Various Time Points. Results The rate of adherence to a study diet was 95. 4% at 1 year and 84.
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