7 NUTS Study. Diet Modification and Male Fertility.
Primary Purpose
Male Subfertility, Oligospermia, Asthenospermia
Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
7 nuts a day
Diet modification
Sponsored by
About this trial
This is an interventional treatment trial for Male Subfertility focused on measuring sperm count, sperm concentration, mobility, diet, PUFA (polyunsaturated fatty acids)
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
Sites / 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 - MoliRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
7 NUTS a day
Diet modification
Arm 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)
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
Outcomes
Primary Outcome Measures
sperm count
Change in sperm count from baseline to 15 weeks
sperm concentration
change in sperm concentration from baseline to 15 weeks
sperm motility
change in sperm motility (% of progressive forms) from baseline to 15 weeks
sperm morphology
change in sperm morphology ( % normal forms ) from baseline to 15 weeks
Secondary Outcome Measures
change in weight (BMI)
change in body weight (BMI) from baseline to 15 weeks
Change in serum cholesterol
change in serum cholesterol levels from baseline to 15 weeks
change in serum folate
change in serum folate from baseline to 15 weeks
change in plasma alpha linolenic acid (ALA) levels
change in ALA levels from baseline to 15 weeks
change in plasma eicosapentaenoic acid (EPA)
change in plasma EPA levels from baseline to 15 weeks
change in plasma docosahexaenoic acid (DHA)
change in plasma DHA levels from baseline to 15 weeks
Full Information
NCT ID
NCT02063256
First Posted
February 13, 2014
Last Updated
May 25, 2014
Sponsor
Azienda Ospedaliera Città della Salute e della Scienza di Torino
1. Study Identification
Unique Protocol Identification Number
NCT02063256
Brief Title
7 NUTS Study. Diet Modification and Male Fertility.
Official Title
7 NUTS Study . A Randomized Dietary Intervention Trial on the Influence of Diet on Human Sperm Quality in Subfertile Men.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Città della Salute e della Scienza di Torino
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Subfertility, Oligospermia, Asthenospermia, Teratospermia
Keywords
sperm count, sperm concentration, mobility, diet, PUFA (polyunsaturated fatty acids)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
7 NUTS a day
Arm Type
Active Comparator
Arm 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)
Arm Title
Diet modification
Arm Type
Experimental
Arm 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
Intervention Type
Dietary Supplement
Intervention Name(s)
7 nuts a day
Intervention Description
add 7 nuts a day (whole shelled weight 75 grams) to standard diet
Intervention Type
Other
Intervention Name(s)
Diet modification
Intervention Description
modify the diet allowing more intake of PUFA rich food and cutting the consumption of saturated fatty acids
Primary Outcome Measure Information:
Title
sperm count
Description
Change in sperm count from baseline to 15 weeks
Time Frame
15 weeks
Title
sperm concentration
Description
change in sperm concentration from baseline to 15 weeks
Time Frame
15 weeks
Title
sperm motility
Description
change in sperm motility (% of progressive forms) from baseline to 15 weeks
Time Frame
15 weeks
Title
sperm morphology
Description
change in sperm morphology ( % normal forms ) from baseline to 15 weeks
Time Frame
15 weeks
Secondary Outcome Measure Information:
Title
change in weight (BMI)
Description
change in body weight (BMI) from baseline to 15 weeks
Time Frame
15 weeks
Title
Change in serum cholesterol
Description
change in serum cholesterol levels from baseline to 15 weeks
Time Frame
15 weeks
Title
change in serum folate
Description
change in serum folate from baseline to 15 weeks
Time Frame
15 weeks
Title
change in plasma alpha linolenic acid (ALA) levels
Description
change in ALA levels from baseline to 15 weeks
Time Frame
15 weeks
Title
change in plasma eicosapentaenoic acid (EPA)
Description
change in plasma EPA levels from baseline to 15 weeks
Time Frame
15 weeks
Title
change in plasma docosahexaenoic acid (DHA)
Description
change in plasma DHA levels from baseline to 15 weeks
Time Frame
15 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aldo Maina, MD
Phone
0039011313
Ext
5735
Email
amaina@citttadellasalute.to.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aldo Maina, MD
Organizational Affiliation
Ospedale Sant'Anna Medicina Interna. Azienda Ospedaliera Universitaria Città della Salute e della Scienza Torino Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
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
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aldo Maina, MD
Phone
0039011313
Ext
5735
Email
amaina@cittadellasalute.to.it
First Name & Middle Initial & Last Name & Degree
Marco Manenti, MD
First Name & Middle Initial & Last Name & Degree
Cinzia Racca, MScBiol
First Name & Middle Initial & Last Name & Degree
Maria Paola Puccinelli, M Chem
First Name & Middle Initial & Last Name & Degree
Emanuele Pesce
12. IPD Sharing Statement
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