BRE-13: Mediterranean Diet
BRE-13
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2027
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2026
CompletedFirst Posted
Study publicly available on registry
October 9, 2026
CompletedStudy Start
First participant enrolled
February 15, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
Study Completion
Last participant's last visit for all outcomes
September 1, 2028
October 9, 2026
October 1, 2026
1.5 years
October 1, 2026
October 6, 2026
Conditions
Outcome Measures
Primary Outcomes (8)
Aim 1a
Fatty acid profile (chain length and degree of saturation) in blood.
3 weeks
Aim 1b
Lipid availability in blood, tumor tissue, and interstitial fluid.
3 weeks
Aim 1c
Fatty acid profile (chain length and degree of saturation) in breast tumor tissue,
3 weeks
Aim 2a
peripheral blood monocyte cells from the electronic health record.
3 weeks
Aim 2b
Tumor tissue will explore the effects on tumor proliferation (Ki67) cells.
3 weeks
Aim 2c
Tumor tissue will explore the effects on expression of NK cells.
3 weeks
Aim 2d
Tumor tissue will explore the effects on CD8 T cells(immunohistochemistry) cells.
3 weeks
Aim 2e
Tumor tissue will explore the effects on chylomicrons (Apo48 staining) cells.
3 weeks
Secondary Outcomes (3)
Exploratory aim a
3weeks
Exploratory aim b
3weeks
Exploratory aim c
3weeks
Study Arms (2)
Med Diet
ACTIVE COMPARATORMediterranean 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).
Usual Diet
NO INTERVENTIONDietary fat and cancer has been conducted in preclinical models of diet-induced obesity, where high-fat diets promote tumor growth
Interventions
Fatty acid profile (chain length and degree of saturation) in circulation of blood, tumor tissue, and tumor interstitial fluid.
Fatty acid profile (chain length and degree of saturation) in breast tumor tissue.
Lipid availability in blood, tumor tissue, and tumor interstitial fluid.
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).
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years;
- Newly diagnosed stage I-III luminal breast cancer
- Planned surgical resection at UI Health
- Ability to speak, read, write, and understand English
- A Mediterranean Eating Pattern for Americans (MEPA-III) score \<13 indicating that they do not currently follow a MedDiet;
- ECOG performance status of 0 or 1.
You may not qualify if:
- Currently following a MedDiet, vegan diet, or dietary restrictions (e.g., religious, food intolerance/allergy) that preclude adoption of a MedDiet;
- Lack of access to a space to safely store and reheat foods items;
- Living in facility that provides meals;
- Chronic CKD stage 3+ or currently receiving dialysis treatment;
- History of GI surgery involving removal of part of the stomach or intestines;
- Type 1 or Type 2 diabetes;
- Autoimmune or Inflammatory disease or immunocompromised; and
- Cachexia.
- We will not exclude other neoadjuvant treatments. Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant or breastfeeding women Prisoners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 1, 2026
First Posted
October 9, 2026
Study Start (Estimated)
February 15, 2027
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
October 9, 2026
Record last verified: 2026-10