Colon Cancer Clinical Trial
Official title:
A Mediterranean Diet in Colon Cancer Prevention
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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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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