Clinical trial · Observational
Phytoestrogens and Colonic Adenomatous Polyps
Bioavailability of Phytoestrogens and Prevalence of Adenomatous Polyps in Human Colon
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intestinal Polyps | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Patients with polyps
- description
- urinary phytoestrogen excretion and intestinal microbiota evaluation
- label
- Patients without polyps
- description
- urinary phytoestrogen excretion and intestinal microbiota evaluation
Primary outcomes (1)
- measure
- Phytoestrogen absorption
- timeFrame
- one day
- description
- It will be evaluated on the basis of their 24h urine excretion
Secondary outcomes (1)
- measure
- Intestinal microbiota
- timeFrame
- one day
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDXu 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. PMID 7666247
- BACKGROUNDAtkinson 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. PMID 15734719
- BACKGROUNDJin H, Leng Q, Li C. Dietary flavonoid for preventing colorectal neoplasms. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD009350. doi: 10.1002/14651858.CD009350.pub2. PMID 22895989
- BACKGROUNDKocic 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. PMID 23613386
- BACKGROUNDSetchell 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. PMID 12468591