BRE-13: Mediterranean Diet

NCT07869355 — Not applicable, Not yet recruiting, 30 participants, University of Illinois at Chicago

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BRE-13: Mediterranean Diet-A Presurgical Window of Opportunity Trial Among Women With Breast Cancer

Registry	NCT07869355, acronym BRE-13
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	30 (Estimated)
Sponsor	University of Illinois at Chicago (Other)
Conditions	Dietary Assessment, Dietary and Lifestyle Behaviour Change, Dietary Behavior, Metabolic Health, Obesity, Lifestyle Modification, Metabolic Syndrome Risk
Interventions	Explore the effect of MedDiet vs. Usual Diet on Fatty Acid Profile, Explore the effect of MedDiet vs. Usual Diet on Breast Tumor Tissue, Explore the effect of MedDiet vs. Usual Diet on Lipids, Explore the effect of MedDiet vs. Usual Diet on tumor tissue expression (Dietary supplement, diagnostic test)
Dates	start 2027-02-15 (estimated), primary completion 2028-09-01 (estimated), completion 2028-09-01 (estimated), first posted 2026-10-09, last updated 2026-10-09

-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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Med Diet	Active comparator	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	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).
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

Explore the effect of MedDiet vs. Usual Diet on Fatty Acid Profile (Dietary supplement): Fatty acid profile (chain length and degree of saturation) in circulation of blood, tumor tissue, and tumor interstitial fluid.
Explore the effect of MedDiet vs. Usual Diet on Breast Tumor Tissue (Diagnostic test): Fatty acid profile (chain length and degree of saturation) in breast tumor tissue.
Explore the effect of MedDiet vs. Usual Diet on Lipids (Diagnostic test): Lipid availability in blood, tumor tissue, and tumor interstitial fluid.
Explore the effect of MedDiet vs. Usual Diet on tumor tissue expression (Diagnostic test): 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).

+Outcome measures

Primary outcomes

Aim 1a [3 weeks]: Fatty acid profile (chain length and degree of saturation) in blood.
Aim 1b [3 weeks]: Lipid availability in blood, tumor tissue, and interstitial fluid.
Aim 1c [3 weeks]: Fatty acid profile (chain length and degree of saturation) in breast tumor tissue,
Aim 2a [3 weeks]: peripheral blood monocyte cells from the electronic health record.
Aim 2b [3 weeks]: Tumor tissue will explore the effects on tumor proliferation (Ki67) cells.
Aim 2c [3 weeks]: Tumor tissue will explore the effects on expression of NK cells.
Aim 2d [3 weeks]: Tumor tissue will explore the effects on CD8 T cells(immunohistochemistry) cells.
Aim 2e [3 weeks]: Tumor tissue will explore the effects on chylomicrons (Apo48 staining) cells.

Secondary outcomes

Exploratory aim a [3weeks]: 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.
Exploratory aim b [3weeks]: Stool will be used to analyze downstream bioinformatics to study compositional and metabolic changes among the two study arms.
Exploratory aim c [3weeks]: Stool will be used to analyze metabolic changes among the two study arms.

+Eligibility

Sex: Female, ages: 18 Years to 80 Years

Inclusion Criteria:

1. Age ≥ 18 years;
2. Newly diagnosed stage I-III luminal breast cancer
3. Planned surgical resection at UI Health
4. Ability to speak, read, write, and understand English
5. A Mediterranean Eating Pattern for Americans (MEPA-III) score <13 indicating that they do not currently follow a MedDiet;
6. ECOG performance status of 0 or 1.

Exclusion Criteria:

1. Currently following a MedDiet, vegan diet, or dietary restrictions (e.g., religious, food intolerance/allergy) that preclude adoption of a MedDiet;
2. Lack of access to a space to safely store and reheat foods items;
3. Living in facility that provides meals;
4. Chronic CKD stage 3+ or currently receiving dialysis treatment;
5. History of GI surgery involving removal of part of the stomach or intestines;
6. Type 1 or Type 2 diabetes;
7. Autoimmune or Inflammatory disease or immunocompromised; and
8. 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

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