Disposition of Dietary Polyphenols and Methylxanthines in Mammary Tissues From Breast Cancer Patients (POLYSEN)
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|ClinicalTrials.gov Identifier: NCT03482401|
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : March 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Dietary Supplement: Polyphenol||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomised, parallel-controlled dietary intervention|
|Masking:||None (Open Label)|
|Official Title:||Metabolic Profiling of Dietary Polyphenols and Methylxanthines in Normal and Malignant Mammary Tissues From Breast Cancer Patients|
|Actual Study Start Date :||June 1, 2017|
|Actual Primary Completion Date :||December 1, 2018|
|Actual Study Completion Date :||December 31, 2019|
Experimental: Polyphenol group
Patients consumed a polyphenol-rich dietary supplement (commercial lemon, orange, pomegranate, olive, grape, cocoa, curcuma and broccoli extracts), mainly rich in simple phenolics such as hydroxytyrosol and the polyphenols procyanidins, hesperidin, eriocitrin, curcumin, resveratrol, punicalagin and ellagic acid. Cocoa extract also contains the methylxanthines theobromine and caffeine.
Dietary Supplement: Polyphenol
Patients consume 3 capsules/day (474 mg phenolics/day) from the biopsy-confirmed breast cancer diagnosis to the surgery
No Intervention: Control group
Participating patients did not consume the supplement but provided biological samples to the trial
- Quantification of dietary polyphenols and methylxanthines in breast tissues [ Time Frame: 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.
- Quantification of dietary polyphenols and methylxanthines in plasma and urine [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482401
|Hospital General Universitario Reina Sofía|
|Murcia, Spain, 30003|
|Principal Investigator:||Juan C. Espín, PhD||National Research Council, Spain|