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7 NUTS Study. Diet Modification and Male Fertility.

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ClinicalTrials.gov Identifier: NCT02063256
Recruitment Status : Unknown
Verified May 2014 by Aldo Maina, Azienda Ospedaliera Città della Salute e della Scienza di Torino.
Recruitment status was:  Recruiting
First Posted : February 14, 2014
Last Update Posted : May 28, 2014
Sponsor:
Information provided by (Responsible Party):
Aldo Maina, Azienda Ospedaliera Città della Salute e della Scienza di Torino

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
  • 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.


Condition or disease Intervention/treatment Phase
Male Subfertility Oligospermia Asthenospermia Teratospermia Dietary Supplement: 7 nuts a day Other: Diet modification Phase 2 Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 7 NUTS Study . A Randomized Dietary Intervention Trial on the Influence of Diet on Human Sperm Quality in Subfertile Men.
Study Start Date : May 2014
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Active Comparator: 7 NUTS a day
the patients allocated to this arm will be instructed to supplement their diet with 7 nuts a day (whole shelled weight around 75 grams)
Dietary Supplement: 7 nuts a day
add 7 nuts a day (whole shelled weight 75 grams) to standard diet

Experimental: Diet modification
the patients allocated to this arm will be instructed to modify their diet allowing more intake of PUFA rich food avoiding saturated fat rich food
Other: Diet modification
modify the diet allowing more intake of PUFA rich food and cutting the consumption of saturated fatty acids




Primary Outcome Measures :
  1. sperm count [ Time Frame: 15 weeks ]
    Change in sperm count from baseline to 15 weeks

  2. sperm concentration [ Time Frame: 15 weeks ]
    change in sperm concentration from baseline to 15 weeks

  3. sperm motility [ Time Frame: 15 weeks ]
    change in sperm motility (% of progressive forms) from baseline to 15 weeks

  4. sperm morphology [ Time Frame: 15 weeks ]
    change in sperm morphology ( % normal forms ) from baseline to 15 weeks


Secondary Outcome Measures :
  1. change in weight (BMI) [ Time Frame: 15 weeks ]
    change in body weight (BMI) from baseline to 15 weeks

  2. Change in serum cholesterol [ Time Frame: 15 weeks ]
    change in serum cholesterol levels from baseline to 15 weeks

  3. change in serum folate [ Time Frame: 15 weeks ]
    change in serum folate from baseline to 15 weeks

  4. change in plasma alpha linolenic acid (ALA) levels [ Time Frame: 15 weeks ]
    change in ALA levels from baseline to 15 weeks

  5. change in plasma eicosapentaenoic acid (EPA) [ Time Frame: 15 weeks ]
    change in plasma EPA levels from baseline to 15 weeks

  6. change in plasma docosahexaenoic acid (DHA) [ Time Frame: 15 weeks ]
    change in plasma DHA levels from baseline to 15 weeks



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • sperm concentration > 5.000.000 ml
  • progressive motile forms < 35%
  • BMI < 30
  • normal FSH (Follicle Stimulating Hormone reference values 1-10 IU)

Exclusion Criteria:

  • allergy to nuts or seeds
  • clinical varicocele
  • recent surgery for varicocele
  • vasectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063256


Contacts
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Contact: Aldo Maina, MD 0039011313 ext 5735 amaina@citttadellasalute.to.it

Locations
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Italy
Ospedale Sant'Anna. Dipartimento di Ostetricia e Neonatologia. S.C. Biochimica Clinica "Baldi e Riberi" Settore Malattie Metaboliche - Dipartimento di Medicina di Laboratorio A.O.U. Citta' della Salute e della Scienza Presidio San Giovanni Battista - Moli Recruiting
Torino, Italy, 10126
Contact: Aldo Maina, MD    0039011313 ext 5735    amaina@cittadellasalute.to.it   
Sub-Investigator: Marco Manenti, MD         
Sub-Investigator: Cinzia Racca, MScBiol         
Sub-Investigator: Maria Paola Puccinelli, M Chem         
Sub-Investigator: Emanuele Pesce         
Sponsors and Collaborators
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Investigators
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Principal Investigator: Aldo Maina, MD Ospedale Sant'Anna Medicina Interna. Azienda Ospedaliera Universitaria Città della Salute e della Scienza Torino Italy

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Responsible Party: Aldo Maina, MD Internal Medicine Obstetric Medicine, Azienda Ospedaliera Città della Salute e della Scienza di Torino
ClinicalTrials.gov Identifier: NCT02063256     History of Changes
Other Study ID Numbers: CS93-2013
First Posted: February 14, 2014    Key Record Dates
Last Update Posted: May 28, 2014
Last Verified: May 2014

Keywords provided by Aldo Maina, Azienda Ospedaliera Città della Salute e della Scienza di Torino:
sperm count
sperm concentration
mobility
diet
PUFA (polyunsaturated fatty acids)

Additional relevant MeSH terms:
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Infertility
Oligospermia
Asthenozoospermia
Infertility, Male
Teratozoospermia
Genital Diseases, Male
Genital Diseases, Female