[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532576":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":32,"locations":40,"responsibleParty":75,"collaborators":32,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":32,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":32,"overallStatus":43,"whyStopped":32,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"University of Belgrade","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"AI Diet","EXPERIMENTAL","Personalised diet rich in whole grains high in fibres, vegetables (particularly leafy greens and tomatoes), polyphenol-rich fruits (berries), and n-3 FAs foods (fatty fish, nuts, seeds and oils)",[13],"Dietary Supplement: AI diet",{"label":15,"type":16,"description":17,"interventionNames":18},"Supplements","ACTIVE_COMPARATOR","2 gel capsules\u002Fd of fish oil (FO) + 3 gel capsules\u002Fd of evening primrose oil (EPO), containing 600 mg EPA, 400 mg DHA and 351 mg GLA + Standard diet: 55% carbohydrate, 15% protein and 30% fats",[19],"Dietary Supplement: Supplement",{"label":21,"type":22,"description":23,"interventionNames":24},"Placebo","PLACEBO_COMPARATOR","Standard diet: 55% carbohydrate, 15% protein and 30% fats + placebo capsules",[25],"Dietary Supplement: Placebo",[27,33,37],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DIETARY_SUPPLEMENT","Supplement","Supplements of anti-inflammatory oils rich in omega-3 and gamma-linolenic acid",[15],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"AI diet","diet rich in whole grains, healthy oils and polyphenols,",[9],{"type":28,"name":21,"description":38,"armGroupLabels":39,"otherNames":32},"Placebo caps with standard diet",[21],[41,60],{"facility":42,"status":43,"city":44,"state":32,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Clinical Hospital Center Bezanijska kosa","RECRUITING","Belgrade","11070","Serbia","RS",{"type":49,"coordinates":50},"Point",[51,52],20.46513,44.80401,{"lat":52,"lon":51},[55],{"name":56,"role":57,"phone":58,"phoneExt":32,"email":59},"Nebojsa Ivanovic, Dr","CONTACT","0603947871","ivanovicnebojsadr@gmail.com",{"facility":61,"status":43,"city":44,"state":32,"zip":62,"country":46,"countryCode":47,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade","11129",{"type":49,"coordinates":64},[51,52],{"lat":52,"lon":51},[67,71,73],{"name":68,"role":57,"phone":69,"phoneExt":32,"email":70},"Vesna Vucic, PhD","+381113031997","vesna.vucic.imr@gmail.com",{"name":72,"role":57,"phone":32,"phoneExt":32,"email":32},"Danijela Ristic Medic, MD PhD",{"name":68,"role":74,"phone":32,"phoneExt":32,"email":32},"PRINCIPAL_INVESTIGATOR",{"type":74,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Vesna Vucic","Principal Investigator","100532576","anti-inflammatory-diet-in-brc-patients-on-aromatase-inhibitors-100532576",false,"NCT06214598","Anti-Inflammatory Diet in BRC Patients on Aromatase Inhibitors","Anti-Inflammatory Dietary Intervention in Breast Cancer Patients Receiving Aromatase Inhibitors","AID","Inclusion Criteria:\n\n* Age: 45 to 70 years\n* Postmenopausal women\n* Histologically confirmed BRC, stage I to IIIa\n* ER positive \u002FHER2 negative\n* Application of adjuvant hormone therapy with aromase inhibitors: 6 to 30 months\n* Body mass index from 20 to 34.9 kg\u002Fm 2\n* Able to understand the requirements of the study and provide written information consent\n\nExclusion Criteria:\n\n* Metastatic or locally advanced disease\n* HER2-positive tumors\n* Presence of other malignant or serious chronic diseases\n* Active infections\n* Previous stroke or heart attack,\n* Rheumatoid arthritis and other types of autoimmune diseases\n* Presence of a significant neurological deficit\n* Dementia\n* Allergy to the ingredients of the dietary preparation or to fish, fish oil and nuts fruits.\n* Allergies to evening primrose oil or other oils containing gamma-linolenic acid (borage, black currant)\n* Use of lipid-lowering drugs (statins, Normolip)\n* Current use of warfarin or other anticoagulants\n* Corticosteroid therapy for the last month\n* Use of dietary supplements based on fish oil, evening primrose, and flaxseed oils, omega 3-6-9 fatty acids, multivitamins with added omega-3 of fatty acids 3 months before the start of the study","FEMALE","45 Years","70 Years",{"count":90,"type":91},90,"ESTIMATED","INTERVENTIONAL",[94],"NA","This project aims to decrease undesirable side effects and increase qulaity of life of aromatase inhibitors therapy in breast cancer survivors, by anti-inflammatory diet or supplementation.",[97],"Breast Cancer","2024-05-07",{"date":100,"type":101},"2024-05-09","ACTUAL",{"date":103,"type":101},"2024-03-01",{"date":105,"type":91},"2026-11-30",{"name":5,"class":6},2]