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
• The planned trial is nutritional based only, with a modification of diet in order to obtain an increase of PUFA intake with/without a reduction of saturated fatty acid intake.

  Two different types of intervention are scheduled:

  • Supplementation to western style diet with food naturally rich in PUFA
  • Diet modification, increasing intake of PUFA naturally rich foods and cutting the consumption of saturated fats.

  The supplementation is obtained adding 7 nuts a day to regular diet. The diet modification is obtained by increasing intake of nuts and seeds (walnuts, hazelnuts, almonds, peanuts, sesame, sunflower, flaxseed) and derived oils, fish and vegetables; cutting the consumption of processed meat and dairy products is required as well.

  The type of diet or supplementation is supported by oral and written information. The compliance to diet will be followed by administration of validated questionnaires.

  The effect of the diet modifications will be followed by a number of plasma biomarkers we plan to compare at baseline and post intervention. The body weight and BMI will be checked, as both types of intervention are intended to not affect significantly mean body weight.

  
  Sponsor: Azienda Ospedaliera Città della Salute e della Scienza di Torino
  

  Current Primary Outcome:

  • sperm count [ Time Frame: 15 weeks ]
    Change in sperm count from baseline to 15 weeks
  • sperm concentration [ Time Frame: 15 weeks ]
    change in sperm concentration from baseline to 15 weeks
  • sperm motility [ Time Frame: 15 weeks ]
    change in sperm motility (% of progressive forms) from baseline to 15 weeks
  • sperm morphology [ Time Frame: 15 weeks ]
    change in sperm morphology ( % normal forms ) from baseline to 15 weeks
  
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:

  • change in weight (BMI) [ Time Frame: 15 weeks ]
    change in body weight (BMI) from baseline to 15 weeks
  • Change in serum cholesterol [ Time Frame: 15 weeks ]
    change in serum cholesterol levels from baseline to 15 weeks
  • change in serum folate [ Time Frame: 15 weeks ]
    change in serum folate from baseline to 15 weeks
  • change in plasma alpha linolenic acid (ALA) levels [ Time Frame: 15 weeks ]
    change in ALA levels from baseline to 15 weeks
  • change in plasma eicosapentaenoic acid (EPA) [ Time Frame: 15 weeks ]
    change in plasma EPA levels from baseline to 15 weeks
  • change in plasma docosahexaenoic acid (DHA) [ Time Frame: 15 weeks ]
    change in plasma DHA levels from baseline to 15 weeks
  
  
  

  Original Secondary Outcome: Same as current
  
  Information By: Azienda Ospedaliera Città della Salute e della Scienza di Torino
  

  Dates:
  Date Received: February 13, 2014
  Date Started: May 2014
  Date Completion: December 2016
  Last Updated: May 25, 2014
  Last Verified: May 2014