7 NUTS Study. Diet Modification and Male Fertility.

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

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.

Study Overview

• Status: Unknown
• Conditions: Oligospermia; Male Subfertility; Teratospermia; Asthenospermia
• Intervention / Treatment: Dietary supplement: 7 nuts a day; Other: Diet modification

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Aldo Maina, MD; Phone Number: 5735 0039011313; Email: amaina@citttadellasalute.to.it

Study Locations

• Italy
  • Torino, Italy, 10126
    • Recruiting
    • 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
    • Contact: Aldo Maina, MD; Phone Number: 5735 0039011313; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sperm count	Change in sperm count from baseline to 15 weeks	15 weeks
sperm concentration	change in sperm concentration from baseline to 15 weeks	15 weeks
sperm motility	change in sperm motility (% of progressive forms) from baseline to 15 weeks	15 weeks
sperm morphology	change in sperm morphology ( % normal forms ) from baseline to 15 weeks	15 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Investigators: Principal Investigator: Aldo Maina, MD, Ospedale Sant'Anna Medicina Interna. Azienda Ospedaliera Universitaria Città della Salute e della Scienza Torino Italy

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ANTICIPATED): May 1, 2016
• Study Completion (ANTICIPATED): December 1, 2016

Study Registration Dates

• First Submitted: February 13, 2014
• First Submitted That Met QC Criteria: February 13, 2014
• First Posted (ESTIMATE): February 14, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): May 28, 2014
• Last Update Submitted That Met QC Criteria: May 25, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: mobility; diet; sperm count; sperm concentration; PUFA (polyunsaturated fatty acids)
• Additional Relevant MeSH Terms: Infertility; Infertility, Male; Oligospermia; Teratozoospermia
• Other Study ID Numbers: CS93-2013