Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2026-01-06 @ 12:37 AM
Study NCT ID:
NCT07270393
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-08
First Post:
2025-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Influence of the Mediterranean Diet on the Quality of Life of Patients With Endometriosis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-11-26', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Personal data', 'timeFrame': '24 weeks', 'description': 'Date and place of birth.'}, {'measure': 'Personal data', 'timeFrame': '24 weeks', 'description': 'Number of children.'}, {'measure': 'Physical examination', 'timeFrame': '24 weeks', 'description': 'Weight (kg)'}, {'measure': 'Physical examination', 'timeFrame': '24 weeks', 'description': 'Height (cm)'}, {'measure': 'Physical examination', 'timeFrame': '24 weeks', 'description': 'Body Mass Index (BMI) (kg/m2)'}, {'measure': 'Physical examination', 'timeFrame': '24 weeks', 'description': 'Abdominal circumference. (cm)'}, {'measure': 'Physical examination', 'timeFrame': '24 weeks', 'description': 'Hip circumference (cm)'}, {'measure': 'Obstetric history', 'timeFrame': '24 weeks', 'description': 'Assisted reproduction treatments (Current/completed/future)'}, {'measure': 'Obstetric history', 'timeFrame': '24 weeks', 'description': 'Gestational desire'}, {'measure': 'Medical history related to endometriosis', 'timeFrame': '24 weeks', 'description': 'Type of endometriosis (Not reported/ Ovarian endometriosis/ Deep endometriosis/ Endometriosis)'}, {'measure': 'Medical history related to endometriosis', 'timeFrame': '24 weeks', 'description': 'Diagnosis of endometriosis by: radiology and/or surgery.'}, {'measure': 'Medical history related to endometriosis', 'timeFrame': '24 weeks', 'description': 'Previous diets performed.'}, {'measure': 'Medical history related to endometriosis', 'timeFrame': '24 weeks', 'description': 'Treatments received: Medical (hormonal contraception, analogues, other).'}, {'measure': 'Medical history related to endometriosis', 'timeFrame': '24 weeks', 'description': 'Treatments received: Surgical (conservative vs. radical surgery).'}, {'measure': 'Current situation related to endometriosis', 'timeFrame': '24 weeks', 'description': 'Symptoms.'}, {'measure': 'Current situation related to endometriosis', 'timeFrame': '24 weeks', 'description': 'Current treatment.'}, {'measure': 'Medical history related to endometriosis', 'timeFrame': '24 weeks', 'description': 'Diagnosis: Date- time of evolution since onset of symptom.'}], 'primaryOutcomes': [{'measure': 'Quality of life and endometriosis.', 'timeFrame': '24 weeks', 'description': 'Endometriosis Health Profile 30 (EHP-30) questionnaire (0-100)'}, {'measure': 'Pain intensity in symptoms related to endometriosis', 'timeFrame': '24 weeks', 'description': 'Pain with menstruation or Dysmenorrhea - A numeric scale (0-10)'}, {'measure': 'Pain intensity in symptoms related to endometriosis', 'timeFrame': '24 weeks', 'description': 'Pain with sexual intercourse or Dyspareunia - A numeric scale (0-10)'}, {'measure': 'Pain intensity in symptoms related to endometriosis', 'timeFrame': '24 weeks', 'description': 'Pain with defecation or Dyschezia - A numeric scale (0-10)'}, {'measure': 'Pain intensity in symptoms related to endometriosis', 'timeFrame': '24 weeks', 'description': 'Pain with urination or Dysuria - A numeric scale (0-10)'}, {'measure': 'Pain intensity in symptoms related to endometriosis', 'timeFrame': '24 weeks', 'description': 'Non-menstrual pelvic pain - A numeric scale (0-10)'}, {'measure': 'Pain intensity in symptoms related to endometriosis', 'timeFrame': '24 weeks', 'description': 'Abdominal bloating or distension - A numeric scale (0-10)'}, {'measure': 'Pain intensity in symptoms related to endometriosis', 'timeFrame': '24 weeks', 'description': 'Tiredness - A numeric scale (0-10)'}], 'secondaryOutcomes': [{'measure': 'General Quality of Life', 'timeFrame': '24 weeks', 'description': 'WHOQOL-BREF questionnaire. (0-100)'}, {'measure': 'Use of analgesics', 'timeFrame': '24 weeks', 'description': 'Collecting the use of analgesics.'}, {'measure': 'Change in BMI', 'timeFrame': '24 weeks', 'description': 'Abdominal and hip circumference. (cm)'}, {'measure': 'Diet quality', 'timeFrame': '24 weeks', 'description': 'Diet Quality Assessment Survey developed by the Spanish Society of Dietetics and Food Sciences (SEDCA).'}, {'measure': 'Adherence to the Mediterranean diet', 'timeFrame': '24 weeks', 'description': 'Diet adherence test, used in the PREDIMED study, available free of charge on the website of the Spanish Society of Dietetics and Food Sciences (SEDCA).'}, {'measure': 'Satisfaction Survey', 'timeFrame': '24 weeks', 'description': "Brief questionnaire that seeks to know the patient's opinion about his or her experience and degree of satisfaction with different aspects of the study."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endometriosis', 'Mediterranean diet', 'Quality of life'], 'conditions': ['Endometriosis']}, 'descriptionModule': {'briefSummary': 'The severities of chronic disease symptoms correlate with the levels of analytical parameters of inflammation. Studies have been published in which the Mediterranean diet has an anti-inflammatory phenomenon, decreasing inflammation parameters. This decrease correlates with an improvement in symptoms.\n\nEndometriosis is a chronic inflammatory disease and the influence of the Mediterranean diet on the decrease of inflammation parameters in women with endometriosis has been studied.\n\nThe studies carried out to assess whether this decrease in inflammatory parameters correlates with clinical improvement and quality of life in these patients have low/very low scientific evidence (small sample size, no control group) and with different interventions (diets, restrictions and/or supplements), which prevent their analysis as a whole.\n\nTherefore, our hypothesis is that the Mediterranean diet, due to its anti-inflammatory effect, can improve the symptomatology and quality of life of patients with endometriosis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION CRITERIA:\n\n* Female.\n* Age 18-45.\n* Premenopausal status.\n* Radiological diagnosis (by transvaginal ultrasound and/or MRI) and/or surgical diagnosis of endometriosis.\n* Follow-up in the Gynecology Department of OSI Donostia (at least 1 visit in the last year).\n* Clinical score of at least 3/10 on the Numerical Scale in at least one symptom related to endometriosis).\n* Possibility of understanding Spanish.\n* Possibility of understanding the indicated dietary recommendations.\n* Acceptance of inclusion in clinical study, by signing informed consent.\n\nEXCLUSION CRITERIA:\n\n* Diagnosis of Eating Disorder.\n* Diagnosis of malabsorptive syndromes: Chron's disease, Ulcerative colitis, short bowel syndrome, gastric by-pass, irritable bowel.\n* Other concomitant diseases that produce CPD.\n* Autoimmune diseases.-\n* Metabolic diseases requiring follow-up of specific diets.\n* Diagnosed gluten intolerance.\n* Vegan diet.\n* Follow-up by a nutritionist.\n* Diagnosis of severe mental illness requiring treatment.\n* Pregnancy or current breastfeeding.\n* Active cancer process.\n* Personal history of gynecologic or digestive oncologic process.\n* Change of treatment or surgery during follow-up.\n* Surgery related to endometriosis or change of treatment in the 6 weeks prior to enrollment in the study.\n* Drug abuse. Opioid analgesia \\< 3 months."}, 'identificationModule': {'nctId': 'NCT07270393', 'briefTitle': 'Study of the Influence of the Mediterranean Diet on the Quality of Life of Patients With Endometriosis.', 'organization': {'class': 'OTHER', 'fullName': 'Biogipuzkoa Health Research Institute'}, 'officialTitle': 'Estudio de la Influencia de la Dieta mediterránea en la Calidad de Vida de Las Pacientes Con Endometriosis.', 'orgStudyIdInfo': {'id': 'PAR-DON-2024-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'This group will not receive normocaloric Mediterranean diet recommendations.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'This group will receive a series of normocaloric Mediterranean diet recommendations.', 'interventionNames': ['Other: Diet supplementation']}], 'interventions': [{'name': 'Diet supplementation', 'type': 'OTHER', 'description': 'The severities of chronic disease symptoms correlate with the levels of analytical parameters of inflammation. Studies have been published in which the Mediterranean diet has an anti-inflammatory phenomenon, decreasing inflammation parameters. This decrease correlates with an improvement in symptoms .\n\nEndometriosis is a chronic inflammatory disease and the influence of the Mediterranean diet on the decrease of inflammation parameters in women with endometriosis has been studied.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20014', 'city': 'Donostia / San Sebastian', 'state': 'Gipuzkoa', 'country': 'Spain', 'facility': 'Hospital Universitario Donostia (HUD)', 'geoPoint': {'lat': 43.31283, 'lon': -1.97499}}], 'centralContacts': [{'name': 'Jone Paredes Goenaga JONE.PAREDESGOENAGA@osakidetza.eus, Ginecology and Obstetrics', 'role': 'CONTACT', 'email': 'JONE.PAREDESGOENAGA@osakidetza.eus', 'phone': '943007478'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogipuzkoa Health Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}