Male SubfertilityPhase 2/3NCT02063256
7 NUTS Study. Diet Modification and Male Fertility.
A Phase 2/3 study testing 7 nuts a day and Diet modification in people with Male Subfertility and Oligospermia, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Male Subfertility, Oligospermia, Asthenospermia
- What is being tested?
- 7 nuts a day and Diet modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- May 2014to Dec 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sperm concentration > 5.000.000 ml
- progressive motile forms < 35%
- BMI < 30
- normal FSH (Follicle Stimulating Hormone reference values 1-10 IU)
Who cannot join
- allergy to nuts or seeds
- clinical varicocele
- recent surgery for varicocele
- vasectomy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
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
Aldo Maina, MD, 0039011313 ext. 5735, amaina@cittadellasalute.to.it
Marco Manenti, MD
About this study
Official title: 7 NUTS Study . A Randomized Dietary Intervention Trial on the Influence of Diet on Human Sperm Quality in Subfertile Men.
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:
Read more
- 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.
Read the 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.
- Conditions
- Male Subfertility, Oligospermia, Asthenospermia, Teratospermia
- Being tested
- 7 nuts a day, Diet modification
- Keywords
- sperm count, sperm concentration, mobility, diet, PUFA (polyunsaturated fatty acids)
- Medical subject headings
- Infertility, Male, Oligospermia, Asthenozoospermia, Teratozoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7 nuts a dayDietary supplement
add 7 nuts a day (whole shelled weight 75 grams) to standard diet
Diet modificationOther
modify the diet allowing more intake of PUFA rich food and cutting the consumption of saturated fatty acids
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Other: Diet modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
sperm count
Change in sperm count from baseline to 15 weeks
Measured: 15 weeks
sperm concentration
change in sperm concentration from baseline to 15 weeks
Measured: 15 weeks
sperm motility
change in sperm motility (% of progressive forms) from baseline to 15 weeks
Measured: 15 weeks
sperm morphology
change in sperm morphology ( % normal forms ) from baseline to 15 weeks
Measured: 15 weeks
Secondary outcomes (6)
change in weight (BMI)
change in body weight (BMI) from baseline to 15 weeks
Measured: 15 weeks
Change in serum cholesterol
change in serum cholesterol levels from baseline to 15 weeks
Measured: 15 weeks
change in serum folate
change in serum folate from baseline to 15 weeks
Measured: 15 weeks
change in plasma alpha linolenic acid (ALA) levels
change in ALA levels from baseline to 15 weeks
Measured: 15 weeks
change in plasma eicosapentaenoic acid (EPA)
change in plasma EPA levels from baseline to 15 weeks
Measured: 15 weeks
change in plasma docosahexaenoic acid (DHA)
change in plasma DHA levels from baseline to 15 weeks
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male SubfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aldo Maina, A.O.U. Città della Salute e della Scienza
- Investigators
- Aldo Maina, MD, Principal investigator, Ospedale Sant'Anna Medicina Interna. Azienda Ospedaliera Universitaria Città della Salute e della Scienza Torino Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063256
- Sponsor's protocol ID
- CS93-2013
- Status last verified
- May 2014
- First submitted
- 13 Feb 2014
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 7 NUTS Study . A Randomized Dietary Intervention Trial on the Influence of Diet on Human Sperm Quality in Subfertile Men.
- ClinicalTrials.gov ID
- NCT02063256
- Acronym / sponsor ID
- CS93-2013
- Conditions
- Male Subfertility, Oligospermia, Asthenospermia, Teratospermia
- Keywords
- sperm count, sperm concentration, mobility, diet, PUFA (polyunsaturated fatty acids)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 14 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7 NUTS a day | Active comparator | Dietary Supplement: 7 nuts a daythe patients allocated to this arm will be instructed to supplement their diet with 7 nuts a day (whole shelled weight around 75 grams) |
| Diet modification | Experimental | Other: Diet modificationthe patients allocated to this arm will be instructed to modify their diet allowing more intake of PUFA rich food avoiding saturated fat rich food |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- sperm concentration > 5.000.000 ml
- progressive motile forms < 35%
- BMI < 30
- normal FSH (Follicle Stimulating Hormone reference values 1-10 IU)
Key exclusion criteria (4 listed)
- allergy to nuts or seeds
- clinical varicocele
- recent surgery for varicocele
- vasectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7 nuts a dayadd 7 nuts a day (whole shelled weight 75 grams) to standard diet | Dietary supplement | 7 NUTS a day |
| Diet modificationmodify the diet allowing more intake of PUFA rich food and cutting the consumption of saturated fatty acids | Other | Diet modification |
Primary outcome
sperm count
Time frame: 15 weeks
Change in sperm count from baseline to 15 weeks
sperm concentration
Time frame: 15 weeks
change in sperm concentration from baseline to 15 weeks
sperm motility
Time frame: 15 weeks
change in sperm motility (% of progressive forms) from baseline to 15 weeks
sperm morphology
Time frame: 15 weeks
change in sperm morphology ( % normal forms ) from baseline to 15 weeks
6 secondary outcomes
change in weight (BMI)
Time frame: 15 weeks
Change in serum cholesterol
Time frame: 15 weeks
change in serum folate
Time frame: 15 weeks
change in plasma alpha linolenic acid (ALA) levels
Time frame: 15 weeks
change in plasma eicosapentaenoic acid (EPA)
Time frame: 15 weeks
change in plasma docosahexaenoic acid (DHA)
Time frame: 15 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aldo Maina, MD principal investigator
Ospedale Sant'Anna Medicina Interna. Azienda Ospedaliera Universitaria Città della Salute e della Scienza Torino Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 7 nuts a day and Diet modification in people with Male Subfertility and Oligospermia, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aldo Maina, MD (0039011313 ext. 5735, amaina@citttadellasalute.to.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sperm count (time frame: 15 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2014.