Background: Human semen quality is affected by lifestyle and environmental factors. Objective: To evaluate the short-term effects of a diet and physical activity intervention on semen quality of healthy young men living in highly polluted areas of Italy. Design, setting, and participants: A randomized controlled trial was conducted. Healthy young men were assigned to an intervention or a control group. Intervention: A 4-mo Mediterranean diet and moderate physical activity program. Outcome measurements and statistical analysis: The primary outcomes were sperm concentration, motility and morphology, concentration of round cells, and semen total antioxidant capacity. Secondary outcomes were adherence to Mediterranean diet and physical activity. All outcomes were measured twice, at the enrollment (t0) and at the end of the intervention (t4). Results and limitations: A total of 263 individuals attended all visits, and underwent examinations and laboratory analyses: 137 in the intervention group and 126 in the control group. The adherence to Mediterranean diet and physical activity level increased more in the intervention group than in the control group from t0 to t4. Sperm concentration, total and progressive motility, and proportion of normal morphology cells increased in the intervention group but decreased in the control group, with statistically significant differences between the two groups at t4. The total antioxidant capacity increased in the intervention group but decreased in the control group, from t0 to t4. Conclusions: Study results showed that an intervention based on Mediterranean diet and regular physical activity can determine an improvement of semen quality in healthy young men. Patient summary: Our study aimed to evaluate the effect of a lifestyle intervention on semen quality of healthy young men. We assigned the 263 enrolled individuals to an intervention or a control group. The intervention group followed a 4-mo Mediterranean diet and moderate physical activity program, at the end of which the participants showed an improvement of semen quality parameters. Our 4-mo lifestyle intervention with a randomized study design showed that an intervention based on Mediterranean diet and regular physical activity can determine an increase of sperm concentration, total and progressive motility, and proportion of spermatozoa with normal morphology, that is, an increase in total antioxidant capacity in healthy young men. These findings underline the effect of lifestyle factors, particularly dietary habits and physical activity, on sperm quality, and show that moderate lifestyle changes recommended for health promotion and chronic disease prevention can also be helpful for preventing male infertility. © 2021 European Association of Urology

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