7 NUTS Study. Diet Modification and Male Fertility.

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Oligospermia; Asthenospermia; Teratospermia; Male Subfertility

Treatments: Other: Diet modification; Dietary Supplement: 7 nuts a day

Study type: Interventional

Funder types: Other

Identifiers

NCT02063256

CS93-2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

7 NUTS a day

Active Comparator group

Description:

the patients allocated to this arm will be instructed to supplement their diet with 7 nuts a day (whole shelled weight around 75 grams)

Treatment:

Dietary Supplement: 7 nuts a day

Diet modification

Experimental group

Description:

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

Treatment:

Other: Diet modification