Effect of a Low AGE Diet on Human Microbiome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Skin AGE level
研究概览
简要总结
This is an intervention study of the effects of food preparation on the gut bacteria in patients with end stage renal disease on peritoneal dialysis. This is a dietary intervention consistent of consuming low amounts of advanced glycation end products (AGEs), the products of protein and sugar interaction during food processing and preparation using high direct heat.
详细描述
Gut microbes can influence numerous aspects of human biology. Alterations in the function and composition of gut microbial flora (gut microbiota) have been linked to different diseases such as obesity, diabetes and inflammation. Advanced Glycation End products (AGEs) are formed via the Maillard reaction, which consists of a complex network of non-enzymatic reactions involving the carbonyl groups of reducing sugars which react with the amino groups of proteins. AGEs are produced in vivo and being consumed. They have been implicated in increased risk of different diseases including atherosclerosis, CAD and kidney diseases. In this study, the investigators are evaluating the effects of consuming a low AGE diet in participants on peritoneal dialysis on the gut bacteria and inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •Patients with ESRD on PD.
- •Patients are able to understand and give consent.
- •Patients with estimated daily dietary AGE intake > 12 AGE Eq/day (12,000 kiloUnits/day) based on 3-day food records.
排除标准
- •Patient on antibiotics in the last three months.
- •Liver cirrhosis, and heart failure with EF < 30%.
- •The use of chemotherapy, immunosuppressive medications, probiotics, and steroid in the last month.
- •Oral iron supplementation in the last month.
- •History of small or large intestine resection or small bowel obstruction
结局指标
主要结局
Skin AGE level
时间窗: baseline and 1 month
Change in AGE levels in the skin at 1 month compared to baseline will be measure using an AGE reader.
次要结局
- Serum AGE level(baseline and 1 month)
- Serum IL-2 level(baseline and 1 month)
- Serum CRP(baseline and 1 month)
- Serum IL-10(baseline and 1 month)
- Serum creatinine level(baseline and 1 month)
- Serum blood urea nitrogen (BUN)(baseline and 1 month)
- Serum p-cresol level(baseline and 1 month)
- Serum indoxyl sulfate(baseline and 1 month)
- Serum vitamin D(baseline and 1 month)