Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
University of Michigan |
---|---|
Information provided by: | University of Michigan |
ClinicalTrials.gov Identifier: | NCT00475722 |
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.
Condition | Intervention |
---|---|
Colon Cancer |
Behavioral: Healthy People 2010 Diet through dietary counseling Behavioral: Mediterranean Diet through dietary counseling |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Mediterranean Diet in Colon Cancer Prevention |
Estimated Enrollment: | 120 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Healthy People 2010 Diet
|
Behavioral: Healthy People 2010 Diet through dietary counseling
6 months telephone counseling
|
2: Experimental
Mediterranean Diet
|
Behavioral: Mediterranean Diet through dietary counseling
6 months telephone counseling
|
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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mary E Rapai, M.A. | 734-615-4844 | mrapai@umich.eud |
Contact: Zora Djuric, Ph.D. | 734-615-6210 | zoralong@umich.edu |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Zora Djuric, Ph.D. | University of Michigan |
Responsible Party: | University of Michigan ( Departmental Administrator ) |
Study ID Numbers: | HUM00007622 |
Study First Received: | May 17, 2007 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00475722 History of Changes |
Health Authority: | United States: Institutional Review Board |
cancer colon prevention healthy eating Mediterranean diet |
PGE2 cyclooxygenase lipoxygenase Healthy People 2010 diet dietary prevention of colon cancer |
Dinoprostone Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Gastrointestinal Neoplasms |
Healthy Intestinal Diseases Colonic Neoplasms Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Colonic Neoplasms Intestinal Neoplasms Colorectal Neoplasms |