Fish Consumption and Gastro-Intestinal Health With Special Emphasis on Reduction of Risk of Colon Cancer and Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 3
- 主要终点
- Apoptosis in colonic biopsy samples
研究概览
简要总结
The purpose of the study is to determine whether increasing the dietary intake of n-3 fatty acids by the consumption of oil-rich fish reduces the risk of developing colorectal cancer.
详细描述
Epidemiological evidence from several countries supports a protective effect of fish consumption on cancer risk and gastrointestinal cancers in particular. Further evidence to support the idea that fish consumption is protective in relation to cancers of the GI tract is now emerging from the European Investigation into Cancer and Nutrition (EPIC).
The FISHGASTRO project is headed by the Institute of Food Research and includes groups from the University of East Anglia, the University of Wageningen, Netherlands and the University of Jena, Germany. The project focuses on assessing the impact of fish consumption on a range of markers of gastrointestinal health associated with ulcerative colitis or colon cancer and on looking at bio-accessibility of a range of nutrients from fish. We aim to recruit a total of 270 patients with gastrointestinal problems in the UK and Netherlands and take biopsy and blood samples before and after asking them to eat two extra portions of fish per week. One group will receive oil rich fish such as salmon while another will be asked to eat white fish. Changes in cell proliferation, apoptosis, inflammatory markers, gene expression and plasma levels of n-3 fatty acids will be compared to a control group only given standard nutritional advice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ulcerative Colitis Patient Group (Group 1):
- •Aged 18 - 80
- •Male or female
- •Diagnosed with ulcerative colitis
- •Attending gastroenterology clinic for routine colonoscopy check-up
- •Willing to increase dietary intake of fish for six months
- •Willing to undergo a flexible sigmoidoscopy examination
- •Polyps/Resection Group (Group 2):
- •Aged 18 - 80
- •Male or female
- •A history of polyps in the colon
- •Attending gastroenterology clinic for routine colonoscopy check-up
- •Willing to increase dietary intake of fish for six months
- •Willing to undergo a flexible sigmoidoscopy examination
- •Control Group (Group 3):
- •Aged 18 - 80
- •Male or female
- •Booked for a colonoscopy examination for the investigation of iron deficiency anaemia of unknown cause (no evidence of macroscopic disease found during examination)
- •Willing to increase dietary intake of fish for six months
- •Willing to undergo a flexible sigmoidoscopy examination
排除标准
- •Ulcerative Colitis Patient Group (Group 1) and Polyps/Resection Group (Group 2):
- •Allergic to fish
- •Receiving anticoagulant therapy
- •Diabetics
- •Pregnant or breast-feeding
- •Organ transplant recipients receiving immunosuppression therapy
- •Prosthetic heart valve
- •Allergic to pethidine
- •Previous diagnosis of bacterial endocarditis
- •Control Group (Group 3):
- •Same as Groups 1 and 2 plus:
- •Received a diagnosis of colorectal cancer following initial investigative colonoscopy (volunteer will be withdrawn from the study when diagnosed as requiring treatment)
- •Received a diagnosis of coeliac disease following initial investigative colonoscopy (volunteer will be withdrawn from the study when diagnosed as requiring a modified diet)
结局指标
主要结局
Apoptosis in colonic biopsy samples
次要结局
- Cell proliferation
- lymphocyte infiltration
- circulating inflammatory markers (cytokines and prostaglandins)
- tissue inflammatory markers (cytokines and prostaglandins)
- faecal water cytotoxicity and genotoxicity
- gene transcription