7 NUTS Study. Diet Modification and Male Fertility.

NCT ID: NCT02063256

Last Updated: 2014-05-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-12-31

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.

Conditions

Male Subfertility; Oligospermia; Asthenospermia; Teratospermia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

7 nuts a day

Intervention Type: DIETARY_SUPPLEMENT

add 7 nuts a day (whole shelled weight 75 grams) to standard diet

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

Group Type: EXPERIMENTAL

Diet modification

Intervention Type: OTHER

modify the diet allowing more intake of PUFA rich food and cutting the consumption of saturated fatty acids

Interventions

7 nuts a day

add 7 nuts a day (whole shelled weight 75 grams) to standard diet

Intervention Type: DIETARY_SUPPLEMENT

Diet modification

modify the diet allowing more intake of PUFA rich food and cutting the consumption of saturated fatty acids

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

A.O.U. Città della Salute e della Scienza

OTHER

Sponsor Role: lead

Responsible Party

Aldo Maina

MD Internal Medicine Obstetric Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aldo Maina, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Sant'Anna Medicina Interna. Azienda Ospedaliera Universitaria Città della Salute e della Scienza Torino Italy

Locations

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

Torino, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Aldo Maina, MD

Role: CONTACT

amaina@citttadellasalute.to.it

0039011313 ext. 5735

Facility Contacts

Aldo Maina, MD

Role: primary

amaina@cittadellasalute.to.it

0039011313 ext. 5735

Other Identifiers

CS93-2013

Identifier Type: -

Identifier Source: org_study_id