7 NUTS Study. Diet Modification and Male Fertility.

Plain-language summary

Setting. Outpatient fertility clinic. Aim. Investigate if a modification in nutritional habits may improve in the short term the qualities of human sperm, testing two hypothesis: i) that adding to the diet a natural whole food rich in polyunsaturated fatty acids (PUFA) OR ii) that reducing the intake of saturated fatty acids and increasing the consumption of PUFA may affect beneficially sperm parameters. Population. N. 100 hypofertile male subjects attending a fertility clinic. Type of study. Interventional study. No drugs or pharmacologic supplementation will be required nor allowed. Two different type of intervention are scheduled: * Supplementation to western style diet with nuts, naturally rich in PUFA * Diet modification increasing intake of PUFA-rich foods and cutting the consumption of food rich in saturated fats. Protocol * Baseline visit and recruiting. * Informed consent * Randomized allocation to treatment group in a 1: 1 manner Blinding. Investigators deputed to sperm analysis and statistician are blinded as to type of intervention. Phases: * i) basal * ii) after 15 weeks That interval is chosen because encompasses an entire spermatogenesis cycle. Outcomes. Primary * sperm count, concentration,morphology and mobility. Secondary: * serum folate assay, * plasma PUFA (ALA, EPA, DHA) assay, * body weight and BMI variation Statistics. A comparison for all sperm parameters (count,concentration,morphologic abnormalities, mobility) will be carried out by an analysis within groups and within patient.

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