Effects of a Western-type Diet on Colorectal Inflammation, Gut Permeability and Systemic Endotoxemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Inflammation in the rectosigmoid epithelium
研究概览
简要总结
This study will look at the inflammatory (changes usually associated with infection/injury to the body) and bowel permeability (bowel's ability to allow contents to enter the body) effects of a Western-style diet (high fat and low in calcium) and a prudent-style diet (low fat and high in calcium) on the colon (large bowel). This study may provide information to prevent colorectal cancer in a high-risk population
详细描述
Hypothesis
Compared to a prudent-style diet, does a western-style diet increase colorectal inflammation thereby increasing gut permeability and causing increased endotoxins and markers of systemic inflammation.
This is a single blind crossover study. Subjects will be randomized to begin on either a WD or a PD for 30 + 3 days. Once that dietary intervention is complete, subjects will have a four (4) week wash-out period and then will be placed on the other dietary intervention for 30 + 3 days. The following study measures are performed during both the dietary intervention study periods. All the baseline tests will be repeated at the end of each dietary intervention 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 (Investigator)
入排标准
- 年龄范围
- 50 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy male or post-menopausal ( 2 years after menopause or stopping HRT)healthy female subjects
- •Age between 50 and 72 years
- •At increased risk for colorectal cancer (this includes those have had a colorectal adenoma excised, or have a first or second degree relative with colorectal neoplasia).
排除标准
- •Personal history of cancer other than non-melanoma skin cancer within the past 10 years
- •History of hereditary non-polyposis colon cancer
- •Intestinal malabsorption, inflammatory bowel disease
- •Prior gastrointestinal surgery other than appendectomy or surgery of the esophagus
- •Any excess bleeding or coagulation disorders
- •Subjects taking anti-coagulants, sterol-binding resins, NSAIDs other than aspirin, < 600mg per day, other study medications, or other multiple medications that might, in the view of the study physicians, alter colonic function or inflammation
- •Total cholesterol greater than 240mg/dl, triglycerides > 600mg, LDL-C > 175
- •Subjects with a history of coronary artery disease
- •HIV positive subjects
- •Subjects taking antibiotics, anti-diabetes, hormone replacement therapy, oral, transplanted or injected contraceptives (thyroid hormone therapy is permitted as long as the subject is euthyroid)
- •Currently participating in other clinical studies or completed participation in other clinical studies within the last 30 days
研究组 & 干预措施
Western style diet
high-fat, low-calcium diet
干预措施: Western style diet (high fat and low in calcium) (Dietary Supplement)
Prudent diet
low-fat, calcium-sufficient diet
干预措施: Prudent-style diet (low fat and high in calcium) (Dietary Supplement)
结局指标
主要结局
Inflammation in the rectosigmoid epithelium
时间窗: visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention
次要结局
- Inflammatory cytokines in the colorectal mucosa and serum(visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention)
- Circulating endotoxin levels(visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention)
- Expression profiles of pro- and anti-inflammatory genes in rectosigmoid biopsies(visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention)
- Gut permeability(visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention)
- Luminal and adherent gut microbiota(visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention)
- Fecal calprotectin levels in the stool samples(visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention)