7 NUTS Study. Diet Modification and Male Fertility.

NCT02063256 | Unknown Phase 2

• 1 other identifier: CS93-2013
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Male Subfertility; Oligospermia; Asthenospermia; Teratospermia

Keywords

sperm count; sperm concentration; mobility; diet; PUFA (polyunsaturated fatty acids)

Outcome Measures

Primary Outcomes (4)

• sperm count

  Change in sperm count from baseline to 15 weeks

  15 weeks

• sperm concentration

  change in sperm concentration from baseline to 15 weeks

  15 weeks

• sperm motility

  change in sperm motility (% of progressive forms) from baseline to 15 weeks

  15 weeks

• sperm morphology

  change in sperm morphology ( % normal forms ) from baseline to 15 weeks

  15 weeks

Secondary Outcomes (6)

• change in weight (BMI)

  15 weeks

• Change in serum cholesterol

  15 weeks

• change in serum folate

  15 weeks

• change in plasma alpha linolenic acid (ALA) levels

  15 weeks

• change in plasma eicosapentaenoic acid (EPA)

  15 weeks

Study Arms (2)

7 NUTS a day

ACTIVE COMPARATOR

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

Dietary Supplement: 7 nuts a day

Diet modification

EXPERIMENTAL

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

Other: Diet modification

Interventions

7 nuts a day DIETARY_SUPPLEMENT

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

7 NUTS a day

Diet modification OTHER

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

Diet modification

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• sperm concentration \> 5.000.000 ml
• progressive motile forms \< 35%
• BMI \< 30
• normal FSH (Follicle Stimulating Hormone reference values 1-10 IU)

You may not qualify if:

• allergy to nuts or seeds
• clinical varicocele
• recent surgery for varicocele
• vasectomy

Sponsors & Collaborators

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

Study Sites (1)

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, 10126, Italy

RECRUITING

MeSH Terms

Conditions

Infertility, Male; Oligospermia; Asthenozoospermia; Teratozoospermia

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Aldo Maina, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aldo Maina, MD

CONTACT

0039011313; amaina@citttadellasalute.to.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Internal Medicine Obstetric Medicine

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: February 14, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 28, 2014

Record last verified: 2014-05

Locations

IT (1)