Dietary AssessmentBRE-13NCT07869355
BRE-13: Mediterranean Diet
A study testing Explore the effect of MedDiet vs. Usual Diet on Fatty Acid Profile, Explore the effect of MedDiet vs. Usual Diet on Breast Tumor Tissue and Explore the effect of MedDiet vs. Usual Diet on Lipids in people with Dietary Assessment and Dietary and Lifestyle Behaviour Change, run by University of Illinois at Chicago.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Dietary Assessment, Dietary and Lifestyle Behaviour Change, Dietary Behavior
- What is being tested?
- Explore the effect of MedDiet vs. Usual Diet on Fatty Acid Profile, Explore the effect of MedDiet vs. Usual Diet on Breast Tumor Tissue and Explore the effect of MedDiet vs. Usual Diet on Lipids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2027to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
About this study
Official title: BRE-13: Mediterranean Diet-A Presurgical Window of Opportunity Trial Among Women With Breast Cancer
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.
- Conditions
- Dietary Assessment, Dietary and Lifestyle Behaviour Change, Dietary Behavior, Metabolic Health, Obesity, Lifestyle Modification
- Being tested
- 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
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Explore the effect of MedDiet vs. Usual Diet on Fatty Acid ProfileDietary 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 TissueDiagnostic test
Fatty acid profile (chain length and degree of saturation) in breast tumor tissue.
Explore the effect of MedDiet vs. Usual Diet on LipidsDiagnostic test
Lipid availability in blood, tumor tissue, and tumor interstitial fluid.
Explore the effect of MedDiet vs. Usual Diet on tumor tissue expressionDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1a
Fatty acid profile (chain length and degree of saturation) in blood.
Measured: 3 weeks
Aim 1b
Lipid availability in blood, tumor tissue, and interstitial fluid.
Measured: 3 weeks
Aim 1c
Fatty acid profile (chain length and degree of saturation) in breast tumor tissue,
Measured: 3 weeks
Aim 2a
peripheral blood monocyte cells from the electronic health record.
Measured: 3 weeks
Aim 2b
Tumor tissue will explore the effects on tumor proliferation (Ki67) cells.
Measured: 3 weeks
Aim 2c
Tumor tissue will explore the effects on expression of NK cells.
Measured: 3 weeks
Aim 2d
Tumor tissue will explore the effects on CD8 T cells(immunohistochemistry) cells.
Measured: 3 weeks
Aim 2e
Tumor tissue will explore the effects on chylomicrons (Apo48 staining) cells.
Measured: 3 weeks
Secondary outcomes (3)
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.
Measured: 3weeks
Exploratory aim b
Stool will be used to analyze downstream bioinformatics to study compositional and metabolic changes among the two study arms.
Measured: 3weeks
Exploratory aim c
Stool will be used to analyze metabolic changes among the two study arms.
Measured: 3weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start15 Feb 2027 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- MedDiet vs. Usual Diet
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Tussing-Humphreys, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869355
- Sponsor's protocol ID
- 2026-0573
- Acronym
- BRE-13
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRE-13: Mediterranean Diet-A Presurgical Window of Opportunity Trial Among Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT07869355
- Acronym / sponsor ID
- BRE-13 / 2026-0573
- Conditions
- Dietary Assessment, Dietary and Lifestyle Behaviour Change, Dietary Behavior, Metabolic Health, Obesity, Lifestyle Modification
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Study start
- 15 Feb 2027 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- MedDiet vs. Usual Diet
| Arm | Type | Receives |
|---|---|---|
| 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 expressionMediterranean 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Explore the effect of MedDiet vs. Usual Diet on Fatty Acid ProfileFatty acid profile (chain length and degree of saturation) in circulation of blood, tumor tissue, and tumor interstitial fluid. | Dietary supplement | Med Diet |
| Explore the effect of MedDiet vs. Usual Diet on Breast Tumor TissueFatty acid profile (chain length and degree of saturation) in breast tumor tissue. | Diagnostic test | Med Diet |
| Explore the effect of MedDiet vs. Usual Diet on LipidsLipid availability in blood, tumor tissue, and tumor interstitial fluid. | Diagnostic test | Med Diet |
| Explore the effect of MedDiet vs. Usual Diet on tumor tissue expressionTumor 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). | Diagnostic test | Med Diet |
Primary outcome
Aim 1a
Time frame: 3 weeks
Fatty acid profile (chain length and degree of saturation) in blood.
Aim 1b
Time frame: 3 weeks
Lipid availability in blood, tumor tissue, and interstitial fluid.
Aim 1c
Time frame: 3 weeks
Fatty acid profile (chain length and degree of saturation) in breast tumor tissue,
Aim 2a
Time frame: 3 weeks
peripheral blood monocyte cells from the electronic health record.
Aim 2b
Time frame: 3 weeks
Tumor tissue will explore the effects on tumor proliferation (Ki67) cells.
Aim 2c
Time frame: 3 weeks
Tumor tissue will explore the effects on expression of NK cells.
Aim 2d
Time frame: 3 weeks
Tumor tissue will explore the effects on CD8 T cells(immunohistochemistry) cells.
Aim 2e
Time frame: 3 weeks
Tumor tissue will explore the effects on chylomicrons (Apo48 staining) cells.
3 secondary outcomes
Exploratory aim a
Time frame: 3weeks
Exploratory aim b
Time frame: 3weeks
Exploratory aim c
Time frame: 3weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Explore the effect of MedDiet vs. Usual Diet on Fatty Acid Profile, Explore the effect of MedDiet vs. Usual Diet on Breast Tumor Tissue and Explore the effect of MedDiet vs. Usual Diet on Lipids in people with Dietary Assessment and Dietary and Lifestyle Behaviour Change, run by University of Illinois at Chicago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1a (time frame: 3 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.