Clinical trial · Interventional
Polyp Prevention Trial
NCT00339625CI-TRIAL-00045109completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The primary objective of the Poly Prevention Trial (PPT) is to determine whether a low fat, high fiber, high vegetable and fruit eating plan will decrease the recurrence of adenomatous polyps of the large bowel. Secondary objectives of the PPT include 1) evaluating the effectiveness of the intervention program with respect to participant achievement of dietary goals; 2) examining the relation of dietary change and biochemical markers in blood; and 3) assessing the impact of the intervention on quality of life indicators.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoma | Adenoma | ONTOLOGY_EXACT | 0.98 |
| Diet | — | UNRESOLVED | — |
| Polyps | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| low fat, high fiber, high fruit and vegetable eating plan | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- low fat, high fiber, high fruit and vegetable eating plan
- interventionNames
- Other: low fat, high fiber, high fruit and vegetable eating plan
- type
- NO_INTERVENTION
- label
- 2
- description
- Usual Diet
Primary outcomes (1)
- measure
- Incidence of polyps in the colon
- timeFrame
- Yearly for 4 years
- description
- Adenoma recurrence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
- Maximum age
- 99 Years
Show eligibility criteria text
* INCLUSION CRITERIA: Men and women who at the time of randomization are 35 years of age or older and have had removed within 6 months of randomization one or more adenomatous polyps confirmed histologically by the Clinical Center trial pathologist. EXCLUSION CRITERIA: Persons with any of the following characteristics are ineligible for the study: Carcinoma in any polyp removed at baseline endoscopy. High grade dysplasia is not considered carcinoma for purposes of study eligibility. Failure to examine the cecum during baseline colonoscopy. Incomplete removal of polyps at baseline colonoscopy. Surgical removal of polyps. Familial polyposis or other polyposis syndromes. Adenomatous polyp discovered before the age of 35. History of large bowel cancer, including intramucosal carcinoma. History of histologically or radiographically confirmed inflammatory bowel disease (ulcerative colitis or Crohn's disease). History of large bowel resection. Weight move than 150% of desirable weight according to the 1983 Metropolitan Life Insurance Tables. Use of lipid-lowering drugs in pharmacologic doses in the last month. Major life-limiting conditions reducing likelihood of completing 4-year follow-up. Already consuming a dietary pattern similar to the intervention eating plan. Any dietary practice, behavior, or attitude that would substantially limit adherence to the intervention program. Participation in other clinical studies that may interfere with participation in the PPT. Unable or unwilling to sign informed consent form. Found to be unreliable and uncooperative providers of dietary information during the pre-randomization period. Able to give reasonable assurance of remaining in the Clinical Center area for duration of the study.
References
Publications (5)
- BACKGROUNDHill MJ, Morson BC, Bussey HJ. Aetiology of adenoma--carcinoma sequence in large bowel. Lancet. 1978 Feb 4;1(8058):245-7. doi: 10.1016/s0140-6736(78)90487-7. PMID 74668
- BACKGROUNDZaridze DG. Environmental etiology of large-bowel cancer. J Natl Cancer Inst. 1983 Mar;70(3):389-400. No abstract available. PMID 6300495
- BACKGROUNDDrasar BS, Irving D. Environmental factors and cancer of the colon and breast. Br J Cancer. 1973 Feb;27(2):167-72. doi: 10.1038/bjc.1973.20. PMID 4694388
- DERIVEDByrd DA, Vogtmann E, Ortega-Villa AM, Wan Y, Gomez M, Hogue S, Warner A, Zhu B, Dagnall C, Jones K, Hicks B, Albert PS, Murphy G, Sinha R. Prospective and Cross-sectional Associations of the Rectal Tissue Microbiome with Colorectal Adenoma Recurrence. Cancer Epidemiol Biomarkers Prev. 2023 Mar 6;32(3):435-443. doi: 10.1158/1055-9965.EPI-22-0608. PMID 36525653
- DERIVEDPerera T, Young MR, Zhang Z, Murphy G, Colburn NH, Lanza E, Hartman TJ, Cross AJ, Bobe G. Identification and monitoring of metabolite markers of dry bean consumption in parallel human and mouse studies. Mol Nutr Food Res. 2015 Apr;59(4):795-806. doi: 10.1002/mnfr.201400847. Epub 2015 Feb 23. PMID 25641932