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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.
There is substantial epidemiological evidence that dietary patterns influence colorectal cancer risk. The associations of any particular nutrient with increased or decreased risks, however, may not be due to that nutrient per se but to the whole foods that are rich in that nutrient. Simultaneously, reducing intakes of foods associated with increased risk while increasing foods identified in preventive diets may be the best approach for prevention. The Cretan-Mediterranean diet in particular appears to hold great promise for cancer prevention. The major components of the traditional Cretan diet have been associated with decreased colon cancer. Relative to the American diet, this diet has lower n-6/n-3 and n-6/n-9 fatty acid ratios, lower polyunsaturated fatty acid intake, lower red meat intake, and higher intakes of plant-based foods and monounsaturated fatty acids.
The hypothesis of this study is that adherence to a Mediterranean type of diet will result in a decrease in n-6 fatty acids and increased n-3 and n-9 fatty acids in human colorectal mucosa. This together with aspects of the diet such as increased intakes of fruits and vegetables, is expected to modulate eicosanoid metabolism and epithelial proliferation in normal mucosa. 120 persons, with an increased risk for colorectal cancer, will be randomized to a modified Mediterranean diet or a Healthy People 2010 diet for six months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Healthy Eating | Active Comparator | Healthy People 2010 Diet using an exchange list |
|
| 2 Mediterranean | Experimental | Mediterranean Diet using an exchange list |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 Healthy Eating | Behavioral | 6 months telephone counseling |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Dietary Goals | Percentage of participants who met 70% of diet goals as outlined in the exchange list | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zora Djuric, Ph.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22640923 | Result | Djuric 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. | |
| 24112099 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Healthy Eating | Healthy People 2010 Diet Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling |
| FG001 | 2 Mediterranean | Mediterranean Diet Mediterranean Diet through dietary counseling: 6 months telephone counseling |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Healthy Eating | Healthy People 2010 Diet using an exchange list 1 Healthy Eating: 6 months telephone counseling |
| BG001 | 2 Mediterranean | Mediterranean Diet using an exchange list 2 Mediterranean: 6 months telephone counseling |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adherence to Dietary Goals | Percentage of participants who met 70% of diet goals as outlined in the exchange list | Posted | Number | percentage of participants meeting goals | 6 months |
|
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 Healthy Eating | Healthy People 2010 Diet Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| surgery | Gastrointestinal disorders | other | Non-systematic Assessment | bowel obstruction |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| various minor conditions | Infections and infestations | other | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Zora Djuric | University of Michigan | 734-615-6210 | zoralong@umich.edu |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| 2 Mediterranean |
| Behavioral |
6 months telephone counseling |
|
| Sidahmed 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. |
| 23592741 | Result | Sen 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. |
| 25903259 | Result | Umoh 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. |
| 25869112 | Result | Djuric 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. |
| 25372556 | Result | Li 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. |
| 24022589 | Result | Porenta SR, Ko YA, Gruber SB, Mukherjee B, Baylin A, Ren J, Djuric Z. Interaction of fatty acid genotype and diet on changes in colonic fatty acids in a Mediterranean diet intervention study. Cancer Prev Res (Phila). 2013 Nov;6(11):1212-21. doi: 10.1158/1940-6207.CAPR-13-0131. Epub 2013 Sep 10. |
| 29274690 | Derived | Djuric Z, Bassis CM, Plegue MA, Ren J, Chan R, Sidahmed E, Turgeon DK, Ruffin MT 4th, Kato I, Sen A. Colonic Mucosal Bacteria Are Associated with Inter-Individual Variability in Serum Carotenoid Concentrations. J Acad Nutr Diet. 2018 Apr;118(4):606-616.e3. doi: 10.1016/j.jand.2017.09.013. Epub 2017 Dec 21. |
| 27548026 | Derived | Sidahmed E, Sen A, Ren J, Patel A, Turgeon DK, Ruffin MT, Brenner DE, Djuric Z. Colonic Saturated Fatty Acid Concentrations and Expression of COX-1, but not Diet, Predict Prostaglandin E2 in Normal Human Colon Tissue. Nutr Cancer. 2016 Oct;68(7):1192-201. doi: 10.1080/01635581.2016.1213866. Epub 2016 Aug 22. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 61 |
| 15 |
| 61 |
| EG001 | 2 Mediterranean | Mediterranean Diet Mediterranean Diet through dietary counseling: 6 months telephone counseling | 2 | 59 | 18 | 59 |
| bipolar relapse | Psychiatric disorders | other | Non-systematic Assessment |
|
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| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |