Intestinal Polyps Clinical Trial
Official title:
Bioavailability of Phytoestrogens and Prevalence of Adenomatous Polyps in Human Colon
INTRODUCTION: The data obtained by experimental studies about the influence of phytoestrogens
on colorectal cancer (CRC) have been very promising. On the other hand, clinical trials have
produced conflicting results. The literature suggests that some subclasses of phytoestrogens
may have protective effects against CRC and colon adenomas, but most of these results come
from population studies based on the dietary intake of phytoestrogens. On these premises, it
is possible to hypothesize that the variability of the data reported in the literature may be
due to the fact that the real absorption of phytoestrogens (by assessing their concentration
in the serum or urine) and/or the ability of the single individual of producing equol was not
evaluated.
PURPOSE: In the present study, the association between the phytoestrogens intake and the
prevalence of colon adenomas was evaluated not only on the basis of the simply dietary intake
but also on the measurement their intestinal absorption. Moreover, a specific evaluation of
equol production by the intestinal flora was performed. Finally, intestinal bacteria involved
in equol production were evaluated.
MATERIALS AND METHODS: Patients with sporadic colon adenomas were enrolled in group I (case) and patients without sporadic colorectal adenomas matched for sex, age and BMI were enrolled in group II (control). All participants underwent the following evaluations: BMI, dietary history (for quantitative and qualitative analysis of dietary habits), quantitative analysis of phytoestrogens (by dietary questionnaires), medications (chronic assumption of aspirin at low doses), characteristics of the polyps (for a calculation the cancer risk), analysis of urinary excretion of phytoestrogens [by high pressure liquid chromatography (HPLC)] and intestinal flora [by mass spectrometry with Matrix Assisted Laser Desorption Ionization Time-of-Flight (MALDI-TOF) technology]. At the enrolment, patients will be invited to assume a standard quantitative of phytoestrogens at 8:00 a.am. and collect both a fecal sample and the urine of the following 24 hrs. ;
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