Phytoestrogens and Colonic Adenomatous Polyps

Intestinal Polyps Clinical Trial

— FITOPOL  

Official title:

Bioavailability of Phytoestrogens and Prevalence of Adenomatous Polyps in Human Colon

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03417258
• Other study ID #: Policlinic Hospital, Bari
• Status: Completed
• Start date: June 15, 2016
• Est. completion date: April 24, 2019

Study information

• Verified date: March 2020
• Source: University of Bari
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 24, 2019
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenomatous Polyps
• Intestinal Polyps
• Polyps

Locations

Country	Name	City	State
Italy	Policlinic Hospital	Bari

Sponsors (1)

Lead Sponsor	Collaborator
University of Bari

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phytoestrogen absorption	It will be evaluated on the basis of their 24h urine excretion	one day
Secondary	Intestinal microbiota	It will be evaluated on fecal samples	one day