Clinical Trial: 7 NUTS Study. Diet Modification and Male Fertility.

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional



Official Title: 7 NUTS Study . A Randomized Dietary Intervention Trial on the Influence of Diet on Human Sperm Quality in Subfertile Men.

Brief 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