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Not yet recruitingNCT07869355BRE-13Updated Oct 9, 2026

BRE-13: Mediterranean Diet

An interventional study of Explore the effect of MedDiet vs. Usual Diet on Fatty Acid Profile and Explore the effect of MedDiet vs. Usual Diet on Breast Tumor Tissue in Dietary Assessment, Dietary and Lifestyle Behaviour Change and Dietary Behavior, sponsored by University of Illinois at Chicago. Not yet recruiting. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Treatment

Updated Oct 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Dietary Assessment
  • Dietary and Lifestyle Behaviour Change
  • Dietary Behavior
  • Metabolic Health
  • Obesity
  • Lifestyle Modification
  • Metabolic Syndrome Risk

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03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's planned enrollment of 30 is below the median of 77 across 5,084 interventional studies indexed under Obesity.

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Lead sponsor

University of Illinois at Chicago is the lead sponsor of 523 studies on the registry; 132 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.

Browse University of Illinois at Chicago studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Med Diet

    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).

    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

  • No intervention
    Usual Diet

    Dietary fat and cancer has been conducted in preclinical models of diet-induced obesity, where high-fat diets promote tumor growth

Interventions

  • Dietary supplementExplore 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.

  • Diagnostic testExplore the effect of MedDiet vs. Usual Diet on Breast Tumor Tissue

    Fatty acid profile (chain length and degree of saturation) in breast tumor tissue.

  • Diagnostic testExplore the effect of MedDiet vs. Usual Diet on Lipids

    Lipid availability in blood, tumor tissue, and tumor interstitial fluid.

  • Diagnostic testExplore 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).

06

What researchers measure

Primary outcomes

  1. Aim 1a

    Fatty acid profile (chain length and degree of saturation) in blood.

    Time frame: 3 weeks

  2. Aim 1b

    Lipid availability in blood, tumor tissue, and interstitial fluid.

    Time frame: 3 weeks

  3. Aim 1c

    Fatty acid profile (chain length and degree of saturation) in breast tumor tissue,

    Time frame: 3 weeks

  4. Aim 2a

    peripheral blood monocyte cells from the electronic health record.

    Time frame: 3 weeks

  5. Aim 2b

    Tumor tissue will explore the effects on tumor proliferation (Ki67) cells.

    Time frame: 3 weeks

  6. Aim 2c

    Tumor tissue will explore the effects on expression of NK cells.

    Time frame: 3 weeks

  7. Aim 2d

    Tumor tissue will explore the effects on CD8 T cells(immunohistochemistry) cells.

    Time frame: 3 weeks

  8. Aim 2e

    Tumor tissue will explore the effects on chylomicrons (Apo48 staining) cells.

    Time frame: 3 weeks

Secondary outcomes

  1. 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.

    Time frame: 3weeks

  2. Exploratory aim b

    Stool will be used to analyze downstream bioinformatics to study compositional and metabolic changes among the two study arms.

    Time frame: 3weeks

  3. Exploratory aim c

    Stool will be used to analyze metabolic changes among the two study arms.

    Time frame: 3weeks

07

Study locations

No study locations are listed for this record.

08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07869355
Lead sponsor
University of Illinois at Chicago
Responsible party
Lisa Tussing-Humphreys (Principal Investigator, University of Illinois at Chicago) — Principal investigator
First posted
Oct 9, 2026
Start date
Feb 15, 2027 (estimated)
Primary completion
Sep 1, 2028 (estimated)
Completion
Sep 1, 2028 (estimated)
Last update
Oct 9, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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