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7 NUTS Study. Diet Modification and Male Fertility.

NCT02063256 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-05-28

No results posted yet for this study

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.

Conditions

  • Male Subfertility
  • Oligospermia
  • Asthenospermia
  • Teratospermia

Interventions

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

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Aldo Maina, MD · Ospedale Sant'Anna Medicina Interna. Azienda Ospedaliera Universitaria Città della Salute e della Scienza Torino Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-05-31
Completion
2016-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02063256 on ClinicalTrials.gov