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On the basis of the results of an interim analysis, the trial was stopped after a median follow-up of 4. Methods We conducted a one-year, multicenter, controlled trial involving 63 obese men and women who were randomly assigned to either a low-carbohydrate, high-protein, high-fat diet or a low-calorie, high-carbohydrate, low-fat (conventional) diet. None of the sponsors had any role in the trial design, data analysis, or reporting of the results. Figure 2 Percentage of Subjects with a Positive Urinary Ketone Concentration, According to Whether They Were on the Low-Carbohydrate Diet or the Conventional (Low-Calorie, High-Carbohydrate) Diet. Abstract Background Observational cohort studies and a secondary prevention trial have shown an inverse association between adherence to the Mediterranean diet and cardiovascular risk. The increase in high-density lipoprotein cholesterol concentrations and the decrease in triglyceride concentrations were greater among subjects on the low-carbohydrate diet than among those on the conventional diet throughout most of the study. The two Mediterranean-diet groups had good adherence to the intervention, according to self-reported intake and biomarker analyses. Participants received quarterly individual and group educational sessions and, depending on group assignment, free provision of extra-virgin olive oil, mixed nuts, or small nonfood gifts. The low-carbohydrate diet was associated with a greater improvement in some risk factors for coronary heart disease. Methods In a multicenter trial in Spain, we randomly assigned participants who were at high cardiovascular risk, but with no cardiovascular disease at enrollment, to one of three diets: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat). 8,9 The Atkins diet, originally published in 1973 and again in 1992 and 2002, may be the most popular of these diets. 10-12 The trial was designed and conducted by the authors, and the protocol was approved by the institutional review boards at all study locations. Beginning on October 1, 2003, participants were randomly assigned, in a 1:1:1 ratio, to one of three dietary intervention groups: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with nuts, or a control diet. We conducted a randomized trial of this diet pattern for the primary prevention of cardiovascular events.
Details of the trial design are provided elsewhere. 8 years. Abstract Background Despite the popularity of the low-carbohydrate, high-protein, high-fat (Atkins) diet, no randomized, controlled trials have evaluated its efficacy. Longer and larger studies are required to determine the long-term safety and efficacy of low-carbohydrate, high-protein, high-fat diets. Detailed enrollment criteria are provided in the Supplementary Appendix, available at NEJM. Professional contact was minimal to replicate the approach used by most dieters. Low-carbohydrate, high-protein, high-fat diets have become increasingly popular, and many best-selling diet books have promoted this approach. All participants provided written informed consent. Conclusions The low-carbohydrate diet produced a greater weight loss (absolute difference, approximately 4 percent) than did the conventional diet for the first six months, but the differences were not significant at one year. Adherence was poor and attrition was high in both groups. A primary end-point event occurred in 288 participants. Both diets significantly decreased diastolic blood pressure and the insulin response to an oral glucose load. org. The primary end point was the rate of major cardiovascular events (myocardial infarction, stroke, or death from cardiovascular causes). Full Text of Methods.
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