Health TrialsbyHealthPanel

BRE-13: Mediterranean Diet

ConditionsDietary AssessmentDietary and Lifestyle Behaviour ChangeDietary BehaviorMetabolic HealthObesityLifestyle ModificationMetabolic Syndrome Risk
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorUniversity of Illinois at Chicago

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Med DietActive comparator 4 interventions
Group B: Usual DietNo intervention 0 interventions

Trial outcomes

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Illinois at Chicago

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: