Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Fecal marker
研究概览
简要总结
Colorectal Cancer is, in non-smokers for both sex, first cause of cancers mortality in Western country.
The main risk factors associated with colorectal cancer depend of lifestyle, and processed meat and red meat could be involved in carcinogenesis by cytotoxic and genotoxic compound linked to lipid peroxidation and nitrosation.
The aim of this study is to study the impact of the daily consumption of beef, processed or not, on lipid peroxidation induced heme iron ; and to study the impact of the daily consumption of ham, processed or not, on the nitrosilation induced heme iron.
详细描述
24 healthy volunteers will be randomized and will start the study. The study will last 12 weeks for each subject. The first week will be a week of adaptation (or run-in period) to the diet which they will have to follow for the duration of study. During this period, they will collect 3 samples of stools and urine. Then subjects will alternate 4 days of diet either with ham, or with ham and pomegranate extract, or with ham enriched with vitamin E or sirloin steak, marinated sirloin steak or marinated cooked sirloin steak. At least, 3 days will separate every period (wash-out) of nutritional intervention. Urines and stools will be collected last 3 days of every interventional period and also last day of every wash out period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index 20 <= BMI <= 30 kg/m2
- •Affiliated to French National Health Insurance
- •Subject giving his written informed consent
- •Subject considered as normal after clinical examination and medical questionnaire
排除标准
- •Previous medical and/or surgery judged by the investigator as incompatible with this study
- •Previous familial of colon, ovarian or breast cancer
- •Chronic pathologies : cardiovascular diseases, cancer, chronic inflammation diseases, renal, intestinal impairments
- •Dislike ham or red meat
- •Heavy consumer of alcohol
- •Practising intensive physical exercise (> 5 hours)
- •Being under someone's supervision
- •Refusal to be registered on the National Volunteers Data file
- •Dietary habits unreliable to controlled food intake
- •Being in exclusion on the National Volunteers Data file
结局指标
主要结局
Fecal marker
时间窗: 12 weeks
TBARS Fecal for red meat pane and NOCs Fecal for ham
次要结局
- NOC(12 weeks)
- TBARs(12 weeks)
- cytotoxic activity of fecal water(12 weeks)
- DHN-MA(12 weeks)
研究者
Adeline BLOT
Clinical research assistant
University Hospital, Clermont-Ferrand