Clinical trial NCT02063256: 7 NUTS Study. Diet Modification and Male Fertility.
Official title: 7 NUTS Study . A Randomized Dietary Intervention Trial on the Influence of Diet on Human Sperm Quality in Subfertile Men.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Male Subfertility
Oligospermia
Asthenospermia
Teratospermia
Keywords: sperm count
sperm concentration
mobility
diet
PUFA (polyunsaturated fatty acids)
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 100
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: sperm count
timeFrame: 15 weeks
measure: sperm concentration
timeFrame: 15 weeks
measure: sperm motility
timeFrame: 15 weeks
measure: sperm morphology
timeFrame: 15 weeks
Secondary outcomes:
measure: change in weight (BMI)
timeFrame: 15 weeks
measure: Change in serum cholesterol
timeFrame: 15 weeks
measure: change in serum folate
timeFrame: 15 weeks
measure: change in plasma alpha linolenic acid (ALA) levels
timeFrame: 15 weeks
measure: change in plasma eicosapentaenoic acid (EPA)
timeFrame: 15 weeks
measure: change in plasma docosahexaenoic acid (DHA)
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Torino
country: Italy
facility: 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
Study officials:
affiliation: Ospedale Sant'Anna Medicina Interna. Azienda Ospedaliera Universitaria Città della Salute e della Scienza Torino Italy
name: Aldo Maina, MD
role: PRINCIPAL_INVESTIGATOR
References: