Rationale and study design of dietary intervention in patients polypectomized for tumors of the colorectum.
We have implemented a randomized controlled dietary intervention in patients polypectomized for tumors of the colorectum to elucidate potential beneficial effects of n-3 polyunsaturated fatty acids (PUFAs) on the development of colorectal tumors. Those individuals in the experimental group were advised not only to decrease their consumption of fats/oils as a whole and foods supplying n-6 PUFAs but also to increase intake of foods and supplements containing n-3 PUFAs, while those in the comparison group were cautioned to reduce intake of fats/oils as a whole. Patients' compliance/adherence was monitored with a semi-quantitative food frequency questionnaire and by assessment of fatty acid concentrations in plasma, membranes of red blood cells and sigmoid colon samples. As for endpoints to assess tumor suppressive effects of n-3 PUFAs, the number/multiplicity, sizes and incidence rates of colorectal tumors were compared between the experimental and comparison groups after 12 and 24 months of the dietary intervention. On the specified assumption, the number of pairs needed for achieving statistical significance was calculated to be approximately 60-80. A randomized controlled trial is under way to secure enough patients, sustain compliance/adherence and minimize dropouts.
Tokudome
Shinkan
S
Department of Health Promotion and Preventive Medicine, Nagoya City University Graduate School of Medical Sciences, Japan. tokudome@med.nagoya-cu.ac.jp
Yokoyama
Yoshifumi
Y
Kamiya
Takeshi
T
Seno
Kyoji
K
Okuyama
Harumi
H
Kuriki
Kiyonori
K
Cheng
Jinglei
J
Nakamura
Takaaki
T
Fujii
Toshiko
T
Ichikawa
Hiromitsu
H
Itoh
Makoto
M
D000230:Adenocarcinoma / Q000628:therapy*; D000236:Adenoma / Q000628:therapy*; D003111:Colonic Polyps / Q000601:surgery*; D015179:Colorectal Neoplasms / Q000628:therapy*; D003123:Colorectal Neoplasms, Hereditary Nonpolyposis / Q000628:therapy; D004032:Diet; D004041:Dietary Fats / Q000008:administration & dosage; D019587:Dietary Supplements; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage; D043371:Fatty Acids, Omega-6; D005231:Fatty Acids, Unsaturated / Q000008:administration & dosage*; D005395:Fish Oils / Q000008:administration & dosage; D006801:Humans; D012107:Research Design
D004041:Dietary Fats; D015525:Fatty Acids, Omega-3; D043371:Fatty Acids, Omega-6; D005231:Fatty Acids, Unsaturated; D005395:Fish Oils