title: Rationale and study design of dietary intervention in patients polypectomized for tumors of the colorectum.
abstract: 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.
authors.affiliation: Department of Health Promotion and Preventive Medicine, Nagoya City University Graduate School of Medical Sciences, Japan. tokudome@med.nagoya-cu.ac.jp
authors.forename: Shinkan
authors.initials: S
authors.lastname: Tokudome
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Yokoyama
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kamiya
authors.forename: Kyoji
authors.initials: K
authors.lastname: Seno
authors.forename: Harumi
authors.initials: H
authors.lastname: Okuyama
authors.forename: Kiyonori
authors.initials: K
authors.lastname: Kuriki
authors.forename: Jinglei
authors.initials: J
authors.lastname: Cheng
authors.forename: Takaaki
authors.initials: T
authors.lastname: Nakamura
authors.forename: Toshiko
authors.initials: T
authors.lastname: Fujii
authors.forename: Hiromitsu
authors.initials: H
authors.lastname: Ichikawa
authors.forename: Makoto
authors.initials: M
authors.lastname: Itoh
mesh_terms: 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
chemical_list: D004041:Dietary Fats; D015525:Fatty Acids, Omega-3; D043371:Fatty Acids, Omega-6; D005231:Fatty Acids, Unsaturated; D005395:Fish Oils