CONTEXT: Healthy lifestyle factors are associated with maintenance of erectile function in men. OBJECTIVE: To determine the effect of weight loss and increased physical activity on erectile and endothelial functions in obese men. DESIGN, SETTING, AND PATIENTS: 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 triglycerides, 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 < 0.001), as did serum concentrations of interleukin 6 (p = 0.03), and c-reactive protein (p = 0.02). The mean (SD) level of physical activity increased more in the intervention group (from 48 (10) to 195 (36) min/wk; p < 0.001) than in the control group (from 51 (9) to 84 (28) min/wk; p < 0.001). The mean (SD) IIEF score improved in the intervention group (from 13.9 (4.0) to 17 (5); p < 0.001), but remained stable in the control group (from 13.5 (4.0) to 13.6 (4.1); p = 0.89). Seventeen men in the intervention group and 3 in the control group (p = 0.001) reported an IIEF score of 22 or higher. In multivariate analyses, changes in body mass index (p = 0.02), physical activity (p = 0.02), and c-reactive protein (p = 0.03) were independently associated with changes in IIEF score. CONCLUSION: Lifestyle changes are associated with improvement in sexual function in about one third of obese men with erectile dysfunction at baseline.

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