Disposition of Dietary Polyphenols and Methylxanthines in Mammary Tissues From Breast Cancer Patients

Metabolic Profiling of Dietary Polyphenols and Methylxanthines in Normal and Malignant Mammary Tissues From Breast Cancer Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03482401

Acronym

POLYSEN

Enrollment

Registered

2018-03-29

Start date

2017-06-01

Completion date

2019-12-31

Last updated

2020-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Polyphenol, Methylxanthine, Metabolism, Breast tissue, Disposition, UPLC-QTOF

Brief summary

The aim is to characterise the metabolic profiling of dietary polyphenols in normal and malignant breast tissues from breast cancer patients.

Detailed description

The objective of this exploratory trial is to determine the disposition and characterise the metabolic profiling of dietary polyphenols in normal and malignant glandular breast tissues from newly diagnosed breast cancer patients. The patients consumed a polyphenol-rich dietary supplement containing 37 different phenolics and 2 methylxanthines (theobromine and caffeine) from the diagnosis to the surgery. The metabolic profiling was characterized in normal and malignant breast tissues as well as plasma and urine using UPLC-ESI-QTOF-MS/MS.

Interventions

DIETARY_SUPPLEMENTPolyphenol

Patients consume 3 capsules/day (474 mg phenolics/day) from the biopsy-confirmed breast cancer diagnosis to the surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Intervention model description

Randomised, parallel-controlled dietary intervention

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Eligible patients are those over 18 years with a newly biopsy-confirmed breast cancer, programmed surgery at least 3 days after the recruitment and no neoadjuvant treatment.

Exclusion criteria

* Suspected intolerance to any component of fruits or vegetables. * Neoadjuvant chemo- or radiotherapy. * Urgent surgery (less than 3 days after the recruitment). * Patient under 18 years. * Patient with breast adenoma.

Design outcomes

Primary

Measure	Time frame	Description
Quantification of dietary polyphenols and methylxanthines in breast tissues	1-24 months	Quantification of dietary polyphenols and methylxanthines in normal and malignant mammary tissues from breast cancer patients using ultra-high resolution liquid chromatography coupled to quadrupole-time-of-flight mass spectrometry (UPLC-ESI-QTOF-MS/MS). * Quantification (pmol/g) of each phenolic-derived metabolite in breast tissues. * Quantification (pmol/g) of each methylxanthine-derived metabolite in breast tissues.

Secondary

Measure	Time frame	Description
Quantification of dietary polyphenols and methylxanthines in plasma and urine	8-24 months	Quantification of dietary polyphenols and methylxanthines in urine and plasma from breast cancer patients using ultra-high resolution liquid chromatography coupled to quadrupole-time-of-flight mass spectrometry (UPLC-ESI-QTOF-MS/MS). * Quantification of each phenolic-derived metabolite in urine and plasma (nmol/L). * Quantification of each methylxanthine-derived metabolite in urine and plasma (nmol/L).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026