FITOPOL: Phytoestrogens and Colonic Adenomatous Polyps

• Sponsor: University of Bari (Other)
• Overall Status: Completed
• CT.gov ID: NCT03417258
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Actual Duration (Months): 34.3
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 30 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Bioavailability of Phytoestrogens and Prevalence of Adenomatous Polyps in Human Colon
• Actual Study Start Date: Jun 15, 2016
• Actual Primary Completion Date: Jun 15, 2017
• Actual Study Completion Date: Apr 24, 2019

Arms and Interventions

Arm	Intervention/Treatment
Patients with polyps urinary phytoestrogen excretion and intestinal microbiota evaluation
Patients without polyps urinary phytoestrogen excretion and intestinal microbiota evaluation

Outcome Measures

Primary Outcome Measures

1. Phytoestrogen absorption [one day]

   It will be evaluated on the basis of their 24h urine excretion

Secondary Outcome Measures

1. Intestinal microbiota [one day]

   It will be evaluated on fecal samples

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Policlinic Hospital	Bari		Italy	70124

Sponsors and Collaborators

• University of Bari

Investigators

• Study Chair: Alfredo Di Leo, University of Bari

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Jan 24, 2018

More Information

Publications

• 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. Review.
• 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. Review.
• 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. Review.
• 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. Review.
• 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.

• Responsible Party: Michele Barone, Researcher, University of Bari
• ClinicalTrials.gov Identifier: NCT03417258
• Other Study ID Numbers: Policlinic Hospital, Bari
• First Posted: Jan 31, 2018
• Last Update Posted: Mar 30, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Michele Barone, Researcher, University of Bari: phytoestrogens; isoflavones; adenomatous polyps; microbiome
• Additional relevant MeSH terms: Adenomatous Polyps; Polyps; Intestinal Polyps

Study Results

No Results Posted as of Mar 30, 2020