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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007248', 'term': 'Infertility, Male'}, {'id': 'D009845', 'term': 'Oligospermia'}, {'id': 'D053627', 'term': 'Asthenozoospermia'}, {'id': 'D000072660', 'term': 'Teratozoospermia'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-25', 'studyFirstSubmitDate': '2014-02-13', 'studyFirstSubmitQcDate': '2014-02-13', 'lastUpdatePostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sperm count', 'timeFrame': '15 weeks', 'description': 'Change in sperm count from baseline to 15 weeks'}, {'measure': 'sperm concentration', 'timeFrame': '15 weeks', 'description': 'change in sperm concentration from baseline to 15 weeks'}, {'measure': 'sperm motility', 'timeFrame': '15 weeks', 'description': 'change in sperm motility (% of progressive forms) from baseline to 15 weeks'}, {'measure': 'sperm morphology', 'timeFrame': '15 weeks', 'description': 'change in sperm morphology ( % normal forms ) from baseline to 15 weeks'}], 'secondaryOutcomes': [{'measure': 'change in weight (BMI)', 'timeFrame': '15 weeks', 'description': 'change in body weight (BMI) from baseline to 15 weeks'}, {'measure': 'Change in serum cholesterol', 'timeFrame': '15 weeks', 'description': 'change in serum cholesterol levels from baseline to 15 weeks'}, {'measure': 'change in serum folate', 'timeFrame': '15 weeks', 'description': 'change in serum folate from baseline to 15 weeks'}, {'measure': 'change in plasma alpha linolenic acid (ALA) levels', 'timeFrame': '15 weeks', 'description': 'change in ALA levels from baseline to 15 weeks'}, {'measure': 'change in plasma eicosapentaenoic acid (EPA)', 'timeFrame': '15 weeks', 'description': 'change in plasma EPA levels from baseline to 15 weeks'}, {'measure': 'change in plasma docosahexaenoic acid (DHA)', 'timeFrame': '15 weeks', 'description': 'change in plasma DHA levels from baseline to 15 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sperm count', 'sperm concentration', 'mobility', 'diet', 'PUFA (polyunsaturated fatty acids)'], 'conditions': ['Male Subfertility', 'Oligospermia', 'Asthenospermia', 'Teratospermia']}, 'descriptionModule': {'briefSummary': 'Setting. Outpatient fertility clinic.\n\nAim. Investigate if a modification in nutritional habits may improve in the short term the qualities of human sperm, testing two hypothesis:\n\ni) that adding to the diet a natural whole food rich in polyunsaturated fatty acids (PUFA)\n\nOR\n\nii) that reducing the intake of saturated fatty acids and increasing the consumption of PUFA may affect beneficially sperm parameters.\n\nPopulation. N. 100 hypofertile male subjects attending a fertility clinic.\n\nType of study. Interventional study. No drugs or pharmacologic supplementation will be required nor allowed.\n\nTwo different type of intervention are scheduled:\n\n* Supplementation to western style diet with nuts, naturally rich in PUFA\n* Diet modification increasing intake of PUFA-rich foods and cutting the consumption of food rich in saturated fats.\n\nProtocol\n\n* Baseline visit and recruiting.\n* Informed consent\n* Randomized allocation to treatment group in a 1: 1 manner\n\nBlinding. Investigators deputed to sperm analysis and statistician are blinded as to type of intervention.\n\nPhases:\n\n* i) basal\n* ii) after 15 weeks That interval is chosen because encompasses an entire spermatogenesis cycle.\n\nOutcomes. Primary\n\n* sperm count, concentration,morphology and mobility.\n\nSecondary:\n\n* serum folate assay,\n* plasma PUFA (ALA, EPA, DHA) assay,\n* body weight and BMI variation\n\nStatistics. A comparison for all sperm parameters (count,concentration,morphologic abnormalities, mobility) will be carried out by an analysis within groups and within patient.', 'detailedDescription': '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.\n\nTwo different types of intervention are scheduled:\n\n* Supplementation to western style diet with food naturally rich in PUFA\n* Diet modification, increasing intake of PUFA naturally rich foods and cutting the consumption of saturated fats.\n\nThe 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.\n\nThe type of diet or supplementation is supported by oral and written information. The compliance to diet will be followed by administration of validated questionnaires.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sperm concentration \\> 5.000.000 ml\n* progressive motile forms \\< 35%\n* BMI \\< 30\n* normal FSH (Follicle Stimulating Hormone reference values 1-10 IU)\n\nExclusion Criteria:\n\n* allergy to nuts or seeds\n* clinical varicocele\n* recent surgery for varicocele\n* vasectomy'}, 'identificationModule': {'nctId': 'NCT02063256', 'briefTitle': '7 NUTS Study. Diet Modification and Male Fertility.', 'organization': {'class': 'OTHER', 'fullName': 'A.O.U. Città della Salute e della Scienza'}, 'officialTitle': '7 NUTS Study . A Randomized Dietary Intervention Trial on the Influence of Diet on Human Sperm Quality in Subfertile Men.', 'orgStudyIdInfo': {'id': 'CS93-2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '7 NUTS a day', '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)', 'interventionNames': ['Dietary Supplement: 7 nuts a day']}, {'type': 'EXPERIMENTAL', 'label': 'Diet modification', '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', 'interventionNames': ['Other: Diet modification']}], 'interventions': [{'name': '7 nuts a day', 'type': 'DIETARY_SUPPLEMENT', 'description': 'add 7 nuts a day (whole shelled weight 75 grams) to standard diet', 'armGroupLabels': ['7 NUTS a day']}, {'name': 'Diet modification', 'type': 'OTHER', 'description': 'modify the diet allowing more intake of PUFA rich food and cutting the consumption of saturated fatty acids', 'armGroupLabels': ['Diet modification']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Aldo Maina, MD', 'role': 'CONTACT', 'email': 'amaina@cittadellasalute.to.it', 'phone': '0039011313', 'phoneExt': '5735'}, {'name': 'Marco Manenti, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cinzia Racca, MScBiol', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maria Paola Puccinelli, M Chem', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Emanuele Pesce', 'role': 'SUB_INVESTIGATOR'}], 'facility': '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', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'centralContacts': [{'name': 'Aldo Maina, MD', 'role': 'CONTACT', 'email': 'amaina@citttadellasalute.to.it', 'phone': '0039011313', 'phoneExt': '5735'}], 'overallOfficials': [{'name': 'Aldo Maina, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Ospedale Sant'Anna Medicina Interna. Azienda Ospedaliera Universitaria Città della Salute e della Scienza Torino Italy"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A.O.U. Città della Salute e della Scienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Internal Medicine Obstetric Medicine', 'investigatorFullName': 'Aldo Maina', 'investigatorAffiliation': 'A.O.U. Città della Salute e della Scienza'}}}}