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Randomized, single-blind trial of 110 obese men (body mass index 30) aged 35 to 55 years, without diabetes, hypertension, or hyperlipidemia, who had erectile dysfunction that was determined by having a score of 21 or less on the International Index of Erectile Function (IIEF). The study was conducted from October 2000 to October 2003 at a university hospital in Italy. Interventions? The 55 men randomly assigned to the intervention group received detailed advice about how to achieve a loss of 10% or more in their total body weight by reducing caloric intake and increasing their level of physical activity. Men in the control group (n = 55) were given general information about healthy food choices and exercise. Main Outcomes Measures? Erectile function score, levels of cholesterol and tryglycerides, circulating levels of interleukin 6, interleukin 8, and C-reactive protein, and endothelial function as assessed by vascular responses to L-arginine. Results? After 2 years, body mass index decreased more in the intervention group (from a mean [SD] of 36.9 [2.5] to 31.2 [2.1]) than in the control group (from 36.4 [2.3] to 35.7 [2.5]) (P.001), as did serum concentrations of interleukin 6 (P = .03), and C-reactive protein (P = .02). The mean (SD) level of physical activity increased more in the intervention group (from 48 [10] to 195 [36] min/wk; P.001) than in the control group (from 51 [9] to 84 [28] min/wk; P.001). The mean (SD) IIEF score improved in the intervention group (from 13.9 [4.0] to 17 [5]; P.001), but remained stable in the control group (from 13.5 [4.0] to 13.6 [4.1]; P = .89). Seventeen men in the intervention group and 3 in the control group (P = .001) reported an IIEF score of 22 or higher. In multivariate analyses, changes in body mass index (P = .02), physical activity (P = .02), and C-reactive protein (P = .03) were independently associated with changes in IIEF score. Conclusion? Lifestyle changes are associated with improvement in sexual function in
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