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Healthy Eating for Colon Cancer Prevention

Primary Purpose

Colon Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
1 Healthy Eating
2 Mediterranean
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colon Cancer focused on measuring cancer, colon, prevention, healthy eating, Mediterranean diet, PGE2, cyclooxygenase, lipoxygenase, Healthy People 2010 diet, dietary prevention of colon cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1 Healthy Eating

2 Mediterranean

Arm Description

Healthy People 2010 Diet using an exchange list

Mediterranean Diet using an exchange list

Outcomes

Primary Outcome Measures

Adherence to Dietary Goals
Percentage of participants who met 70% of diet goals as outlined in the exchange list

Secondary Outcome Measures

Full Information

First Posted
May 17, 2007
Last Updated
August 18, 2016
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT00475722
Brief Title
Healthy Eating for Colon Cancer Prevention
Official Title
A Mediterranean Diet in Colon Cancer Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
cancer, colon, prevention, healthy eating, Mediterranean diet, PGE2, cyclooxygenase, lipoxygenase, Healthy People 2010 diet, dietary prevention of colon cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Healthy Eating
Arm Type
Active Comparator
Arm Description
Healthy People 2010 Diet using an exchange list
Arm Title
2 Mediterranean
Arm Type
Experimental
Arm Description
Mediterranean Diet using an exchange list
Intervention Type
Behavioral
Intervention Name(s)
1 Healthy Eating
Intervention Description
6 months telephone counseling
Intervention Type
Behavioral
Intervention Name(s)
2 Mediterranean
Intervention Description
6 months telephone counseling
Primary Outcome Measure Information:
Title
Adherence to Dietary Goals
Description
Percentage of participants who met 70% of diet goals as outlined in the exchange list
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zora Djuric, Ph.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22640923
Citation
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.
Results Reference
result
PubMed Identifier
24112099
Citation
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.
Results Reference
result
PubMed Identifier
23592741
Citation
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.
Results Reference
result
PubMed Identifier
25903259
Citation
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.
Results Reference
result
PubMed Identifier
25869112
Citation
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.
Results Reference
result
PubMed Identifier
25372556
Citation
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.
Results Reference
result
PubMed Identifier
24022589
Citation
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.
Results Reference
result
PubMed Identifier
29274690
Citation
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.
Results Reference
derived
PubMed Identifier
27548026
Citation
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.
Results Reference
derived

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Healthy Eating for Colon Cancer Prevention

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