[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659693":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":53,"studyPopulation":45,"armGroups":54,"interventions":68,"overallOfficials":45,"centralContacts":45,"locations":45,"responsibleParty":87,"collaborators":45,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":45,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":45,"overallStatus":117,"whyStopped":45,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":45},{"fullName":5,"class":6},"University of Illinois at Chicago","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":34,"otherOutcomes":45},[9,13,16,19,22,25,28,31],{"measure":10,"description":11,"timeFrame":12},"Aim 1a","Fatty acid profile (chain length and degree of saturation) in blood.","3 weeks",{"measure":14,"description":15,"timeFrame":12},"Aim 1b","Lipid availability in blood, tumor tissue, and interstitial fluid.",{"measure":17,"description":18,"timeFrame":12},"Aim 1c","Fatty acid profile (chain length and degree of saturation) in breast tumor tissue,",{"measure":20,"description":21,"timeFrame":12},"Aim 2a","peripheral blood monocyte cells from the electronic health record.",{"measure":23,"description":24,"timeFrame":12},"Aim 2b","Tumor tissue will explore the effects on tumor proliferation (Ki67) cells.",{"measure":26,"description":27,"timeFrame":12},"Aim 2c","Tumor tissue will explore the effects on expression of NK cells.",{"measure":29,"description":30,"timeFrame":12},"Aim 2d","Tumor tissue will explore the effects on CD8 T cells(immunohistochemistry) cells.",{"measure":32,"description":33,"timeFrame":12},"Aim 2e","Tumor tissue will explore the effects on chylomicrons (Apo48 staining) cells.",[35,39,42],{"measure":36,"description":37,"timeFrame":38},"Exploratory aim a","Stool will be used to analyze gut microbiome changes using shotgun bioinformatics and downstream bioinformatics to study compositional and metabolic changes among the two study arms.","3weeks",{"measure":40,"description":41,"timeFrame":38},"Exploratory aim b","Stool will be used to analyze downstream bioinformatics to study compositional and metabolic changes among the two study arms.",{"measure":43,"description":44,"timeFrame":38},"Exploratory aim c","Stool will be used to analyze metabolic changes among the two study arms.",null,{"allocation":47,"interventionModel":48,"interventionModelDescription":49,"primaryPurpose":50,"observationalModel":45,"timePerspective":45,"maskingInfo":51},"RANDOMIZED","PARALLEL","MedDiet vs. Usual Diet","TREATMENT",{"masking":52,"maskingDescription":45,"whoMasked":45},"NONE","Conduct a 3-week presurgical window trial among 30 women with stage I-III luminal breast cancer. Participants will be randomized 1:1 to a controlled MedDiet or an enhanced usual-care control. This study will generate critical translational data on how dietary fat composition influences tumor metabolism and immune response, informing future diet-based cancer interventions.",[55,64],{"label":56,"type":57,"description":58,"interventionNames":59},"Med Diet","ACTIVE_COMPARATOR","Mediterranean Diet (MedDiet) is a dietary pattern characterized by a low intake of saturated fats and a high intake of unsaturated fats, with olive oil as the primary culinary fat (7, 8).",[60,61,62,63],"Dietary Supplement: Explore the effect of MedDiet vs. Usual Diet on Fatty Acid Profile","Diagnostic Test: Explore the effect of MedDiet vs. Usual Diet on Breast Tumor Tissue","Diagnostic Test: Explore the effect of MedDiet vs. Usual Diet on Lipids","Diagnostic Test: Explore the effect of MedDiet vs. Usual Diet on tumor tissue expression",{"label":65,"type":66,"description":67,"interventionNames":45},"Usual Diet","NO_INTERVENTION","Dietary fat and cancer has been conducted in preclinical models of diet-induced obesity, where high-fat diets promote tumor growth",[69,74,79,83],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":45},"DIETARY_SUPPLEMENT","Explore the effect of MedDiet vs. Usual Diet on Fatty Acid Profile","Fatty acid profile (chain length and degree of saturation) in circulation of blood, tumor tissue, and tumor interstitial fluid.",[56],{"type":75,"name":76,"description":77,"armGroupLabels":78,"otherNames":45},"DIAGNOSTIC_TEST","Explore the effect of MedDiet vs. Usual Diet on Breast Tumor Tissue","Fatty acid profile (chain length and degree of saturation) in breast tumor tissue.",[56],{"type":75,"name":80,"description":81,"armGroupLabels":82,"otherNames":45},"Explore the effect of MedDiet vs. Usual Diet on Lipids","Lipid availability in blood, tumor tissue, and tumor interstitial fluid.",[56],{"type":75,"name":84,"description":85,"armGroupLabels":86,"otherNames":45},"Explore the effect of MedDiet vs. Usual Diet on tumor tissue expression","Tumor tissue will explore the effect of MedDiet vs. Usual Diet on tumor proliferation (Ki67) and expression of NK and CD8 T cells and chylomicrons (Apo48 staining).",[56],{"type":88,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"PRINCIPAL_INVESTIGATOR","Lisa Tussing-Humphreys","Principal Investigator","100659693","bre-13-mediterranean-diet-100659693",false,"NCT07869355","BRE-13: Mediterranean Diet","BRE-13: Mediterranean Diet-A Presurgical Window of Opportunity Trial Among Women With Breast Cancer","BRE-13","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Newly diagnosed stage I-III luminal breast cancer\n3. Planned surgical resection at UI Health\n4. Ability to speak, read, write, and understand English\n5. A Mediterranean Eating Pattern for Americans (MEPA-III) score \\\u003C13 indicating that they do not currently follow a MedDiet;\n6. ECOG performance status of 0 or 1.\n\nExclusion Criteria:\n\n1. Currently following a MedDiet, vegan diet, or dietary restrictions (e.g., religious, food intolerance\u002Fallergy) that preclude adoption of a MedDiet;\n2. Lack of access to a space to safely store and reheat foods items;\n3. Living in facility that provides meals;\n4. Chronic CKD stage 3+ or currently receiving dialysis treatment;\n5. History of GI surgery involving removal of part of the stomach or intestines;\n6. Type 1 or Type 2 diabetes;\n7. Autoimmune or Inflammatory disease or immunocompromised; and\n8. Cachexia.\n\nWe will not exclude other neoadjuvant treatments. Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant or breastfeeding women Prisoners","FEMALE","18 Years","80 Years",{"count":103,"type":104},30,"ESTIMATED","INTERVENTIONAL",[107],"NA","Explore the effect of MedDiet vs. Usual Diet on circulating and breast tumor fatty acid profiles. The investigators aim to examine impact on tumor biology in newly diagnosed participants.",[110,111,112,113,114,115,116],"Dietary Assessment","Dietary and Lifestyle Behaviour Change","Dietary Behavior","Metabolic Health","Obesity","Lifestyle Modification","Metabolic Syndrome Risk","NOT_YET_RECRUITING","2026-10-06",{"date":120,"type":121},"2026-10-09","ACTUAL",{"date":123,"type":104},"2027-02-15",{"date":125,"type":104},"2028-09-01",{"name":5,"class":6}]