Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-03 @ 2:00 AM
Study NCT ID:
NCT02063256
Status:
UNKNOWN
Last Update Posted:
2014-05-28
First Post:
2014-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
7 NUTS Study. Diet Modification and Male Fertility.
Sponsor:
A.O.U. Città della Salute e della Scienza
Organization:
Study Overview
Official Title:
7 NUTS Study . A Randomized Dietary Intervention Trial on the Influence of Diet on Human Sperm Quality in Subfertile Men.
Status:
UNKNOWN
Status Verified Date:
2014-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: