Clinical trial · Interventional
Healthy Eating for Colon Cancer Prevention
A Mediterranean Diet in Colon Cancer Prevention
NCT00475722CI-TRIAL-00024032completedN/AResults postedClinicalTrials.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 purpose of this study is to help develop diets for colon cancer prevention. This study will compare the Mediterranean diet to the Healthy People 2010 diet in 120 subjects with increased risk for colorectal cancer.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 1 Healthy Eating | Behavioral | — | UNRESOLVED |
| 2 Mediterranean | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1 Healthy Eating
- description
- Healthy People 2010 Diet using an exchange list
- interventionNames
- Behavioral: 1 Healthy Eating
- type
- EXPERIMENTAL
- label
- 2 Mediterranean
- description
- Mediterranean Diet using an exchange list
- interventionNames
- Behavioral: 2 Mediterranean
Primary outcomes (1)
- measure
- Adherence to Dietary Goals
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Prior adenomatous polyp. * Prior resected early (Dukes A, B, or C) colon cancer. With the exception of curative surgery for small lesions, such as endoscopically removed cancers, eligible subject will be at least two years post treatment for colorectal cancer. * A history of colon cancer in a primary relative or in two secondary relatives. * Good general health and not expecting major lifestyle changes in the next 6 months. * Age 21 or older. * Not expecting a change in hormonal therapies over the next 6 months. * Taking less than 81 mg/day or 325 mg aspirin every other day for prevention of cardiovascular disease. * Dietary intake that is within the usual range for a typical American diet. * Read and understand English. * Sign the consent and willing to comply with all study procedures. * Have a telephone. * At least 5 years post any type of treatment for any other cancer except cancers that were removed completely by surgery and no other treatment was undergone. * No more than occasional use (\< 25% of the time) of pain medications and willing to take only regular strength acetaminophen while on study except for 81 mg/day or 325 mg every other day of aspirin for prevention of cardiovascular disease. Exclusion Criteria: * On medically prescribed diets or following a diet that would require extensive counseling to correct nutritional deficiencies. * Taking supplements or medications that might obscure our ability to detect an effect of diet (eg. lipid-lowering medications, insulin, fish oils, mega-vitamins). * Are pregnant or lactating or planning to get pregnant. * Previous diagnosis of HIV or hepatitis C. * Have cancer at the present time. * Being treated with or taking therapies or supplements that could obscure our ability to detect diet effects, such as fish oils. * Previous advanced cancer (Duke's D) or hereditary and familial polyposis (HNPCC/FAP) because the latter are rare conditions with unique etiology. * Due to the effects of inflammation on biomarker levels in mucosa, persons with Crohn's disease or inflammatory bowel disease will be excluded. * Persons with BMI \< 18.5 or \> 35 kg/m2 since low BMI could indicate eating disorders and high BMI values, above the midpoint of the obesity range, could indicate more prevalent health problems and these persons can be more difficult to counsel. * Persons taking very high levels of aspirin or non-steroidal anti-inflammatory agents (NSAIDS) for conditions such as arthritis, a chronic inflammatory condition, will be excluded since it will preclude our ability to detect a further decrease in PGE2.
References
Publications (9)
- RESULTDjuric Z, Ruffin MT 4th, Rapai ME, Cornellier ML, Ren J, Ferreri TG, Askew LM, Sen A, Brenner DE, Turgeon DK. A Mediterranean dietary intervention in persons at high risk of colon cancer: recruitment and retention to an intensive study requiring biopsies. Contemp Clin Trials. 2012 Sep;33(5):881-8. doi: 10.1016/j.cct.2012.05.006. Epub 2012 May 26. PMID 22640923
- RESULTSidahmed E, Cornellier ML, Ren J, Askew LM, Li Y, Talaat N, Rapai MS, Ruffin MT, Turgeon DK, Brenner D, Sen A, Djuric Z. Development of exchange lists for Mediterranean and Healthy Eating diets: implementation in an intervention trial. J Hum Nutr Diet. 2014 Oct;27(5):413-25. doi: 10.1111/jhn.12158. Epub 2013 Sep 20. PMID 24112099
- RESULTSen A, Ren J, Ruffin MT, Turgeon DK, Brenner DE, Sidahmed E, Rapai ME, Cornellier ML, Djuric Z. Relationships between serum and colon concentrations of carotenoids and fatty acids in randomized dietary intervention trial. Cancer Prev Res (Phila). 2013 Jun;6(6):558-65. doi: 10.1158/1940-6207.CAPR-13-0019. Epub 2013 Apr 16. PMID 23592741
- RESULTUmoh FI, Kato I, Ren J, Wachowiak PL, Ruffin MT 4th, Turgeon DK, Sen A, Brenner DE, Djuric Z. Markers of systemic exposures to products of intestinal bacteria in a dietary intervention study. Eur J Nutr. 2016 Mar;55(2):793-798. doi: 10.1007/s00394-015-0900-7. Epub 2015 Apr 24. PMID 25903259
- RESULTDjuric Z, Turgeon DK, Ren J, Neilson A, Plegue M, Waters IG, Chan A, Askew LM, Ruffin MT 4th, Sen A, Brenner DE. Effects of a Mediterranean Diet Intervention on Anti- and Pro-Inflammatory Eicosanoids, Epithelial Proliferation, and Nuclear Morphology in Biopsies of Normal Colon Tissue. Nutr Cancer. 2015;67(5):721-9. doi: 10.1080/01635581.2015.1029637. Epub 2015 Apr 14. PMID 25869112
- RESULTLi Y, Sen A, Ren J, Askew LM, Sidahmed E, Brenner DE, Ruffin MT 4th, Turgeon DK, Djuric Z. Effects of vitamin E from supplements and diet on colonic alpha- and gamma-tocopherol concentrations in persons at increased colon cancer risk. Nutr Cancer. 2015;67(1):73-81. doi: 10.1080/01635581.2015.965333. Epub 2014 Nov 5.