7 NUTS Study. Diet Modification and Male Fertility.

Oligospermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02063256
• Other study ID #: CS93-2013
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: February 13, 2014
• Last updated: May 25, 2014
• Start date: May 2014
• Est. completion date: December 2016

Study information

• Verified date: May 2014
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: Aldo Maina, MD
• Phone: 0039011313
• Email: amaina[@]citttadellasalute.to.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthenospermia
• Asthenozoospermia
• Male Subfertility
• Oligospermia
• Teratospermia

Intervention

Dietary Supplement:
• 7 nuts a day
add 7 nuts a day (whole shelled weight 75 grams) to standard diet

Other:
• Diet modification
modify the diet allowing more intake of PUFA rich food and cutting the consumption of saturated fatty acids

Locations

Country	Name	City	State
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	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sperm count	Change in sperm count from baseline to 15 weeks	15 weeks	No
Primary	sperm concentration	change in sperm concentration from baseline to 15 weeks	15 weeks	No
Primary	sperm motility	change in sperm motility (% of progressive forms) from baseline to 15 weeks	15 weeks	No
Primary	sperm morphology	change in sperm morphology ( % normal forms ) from baseline to 15 weeks	15 weeks	No
Secondary	change in weight (BMI)	change in body weight (BMI) from baseline to 15 weeks	15 weeks	Yes
Secondary	Change in serum cholesterol	change in serum cholesterol levels from baseline to 15 weeks	15 weeks	Yes
Secondary	change in serum folate	change in serum folate from baseline to 15 weeks	15 weeks	No
Secondary	change in plasma alpha linolenic acid (ALA) levels	change in ALA levels from baseline to 15 weeks	15 weeks	No
Secondary	change in plasma eicosapentaenoic acid (EPA)	change in plasma EPA levels from baseline to 15 weeks	15 weeks	No
Secondary	change in plasma docosahexaenoic acid (DHA)	change in plasma DHA levels from baseline to 15 weeks	15 weeks	No