Phytoestrogens and Colonic Adenomatous Polyps (FITOPOL)

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.

Study Overview

• Status: Completed
• Conditions: Intestinal Polyps

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70124
    • Policlinic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients (aged between 50 and 75 years) undergoing colonoscopy within 3 months from the study evaluation.

Description

Inclusion Criteria:

• subjects of both sexes aged between 50 and 75 years
• colonoscopy within 3 months from the study evaluation

Exclusion Criteria:

• age < 50 and > 75 years
• previous diagnosis of colon cancer or inflammatory bowel diseases (IBD)
• Hereditary intestinal tumors (FAP, HNPCC, ...)
• ongoing infections
• intake, in the last 4 weeks, of drugs that alter the intestinal bacterial flora
• creatinine clearance below 60 ml/min
• liver failure

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with polyps; urinary phytoestrogen excretion and intestinal microbiota evaluation
Patients without polyps; urinary phytoestrogen excretion and intestinal microbiota evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phytoestrogen absorption	It will be evaluated on the basis of their 24h urine excretion	one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal microbiota	It will be evaluated on fecal samples	one day

Collaborators and Investigators

• Sponsor: University of Bari
• Investigators: Study Chair: Alfredo Di Leo, University of Bari

Publications and helpful links

General Publications

• Xu X, Harris KS, Wang HJ, Murphy PA, Hendrich S. Bioavailability of soybean isoflavones depends upon gut microflora in women. J Nutr. 1995 Sep;125(9):2307-15. doi: 10.1093/jn/125.9.2307.
• Atkinson C, Frankenfeld CL, Lampe JW. Gut bacterial metabolism of the soy isoflavone daidzein: exploring the relevance to human health. Exp Biol Med (Maywood). 2005 Mar;230(3):155-70. doi: 10.1177/153537020523000302.
• Jin H, Leng Q, Li C. Dietary flavonoid for preventing colorectal neoplasms. Cochrane Database Syst Rev. 2012 Aug 15;(8):CD009350. doi: 10.1002/14651858.CD009350.pub2.
• Kocic B, Kitic D, Brankovic S. Dietary flavonoid intake and colorectal cancer risk: evidence from human population studies. J BUON. 2013 Jan-Mar;18(1):34-43.
• Setchell KD, Brown NM, Lydeking-Olsen E. The clinical importance of the metabolite equol-a clue to the effectiveness of soy and its isoflavones. J Nutr. 2002 Dec;132(12):3577-84. doi: 10.1093/jn/132.12.3577.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2016
• Primary Completion (ACTUAL): June 15, 2017
• Study Completion (ACTUAL): April 24, 2019

Study Registration Dates

• First Submitted: January 18, 2018
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (ACTUAL): January 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 26, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: microbiome; isoflavones; phytoestrogens; adenomatous polyps
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Adenoma; Polyps; Intestinal Polyps; Adenomatous Polyps
• Other Study ID Numbers: Policlinic Hospital, Bari

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No