Dietary Fiber in Nutritional Therapy for Chronic Diseases
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change of total cholesterol (TC) level
研究概览
简要总结
The prevalence of chronic disease is increasing rapidly in China. Medical nutritional therapy (MNT) is essential for the prevention and control of chronic diseases. For example, dietary fiber plays an important role in chronic disease management. Evidence suggests that increasing fiber intake can decrease the risk of chronic diseases, such as overweight/obesity, hyperlipidemia, hyperglycemia, GI diseases, etc. However, according to the nation-wide survey, the dietary fiber intake of Chinese people shows a downward trend in recent years, and the relationship between dietary fiber and metabolism of chronic patients is still controversial. So, this study aims to explore the effects of dietary fiber on metabolism, inflammatory factors and nutritional status among patients with chronic diseases, so as to provide reference for proper nutrition intervention towards chronic disease.
详细描述
Investigators plan to recruit potential participants in hospital clinics using posters. An anticipated total of 120 patients with chronic diseases (including overweight, obesity, hyperlipemia, hyperglycemia, etc) will be randomized to receive oat beta-glucans (study group) or routine nutrition management (control group) respectively. The outcome parameters, including weight, blood glucose level, blood fat level, etc, will be measured and compared over a 12-week intervention period. Intention-to-treat analysis (ITT) and per-protocol analysis (PP) will be conducted in statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70y
- •Be diagnosed with obesity, hyperlipemia or hyperglycemia
- •Fully understood and voluntarily signed the informed consent
排除标准
- •Secondary hyperlipidemia or hyperglycemia
- •Multiple organ failure
- •Allergic or intolerant to dietary fiber(dietary supplement)
- •Have gastrointestinal diseases
- •Have a history of abdominal diseases
- •Experienced intra-abdominal surgery
- •Pregnant and lactating women
结局指标
主要结局
Change of total cholesterol (TC) level
时间窗: baseline, 12 weeks
Total cholesterol (TC) level obtained from laboratory test
Change of low density lipoprotein (LDL) cholesterol level
时间窗: baseline, 12 weeks
Low density lipoprotein (LDL) cholesterol level obtained from laboratory test
次要结局
- Change of tumor necrosis factor-alpha level(baseline, 12 weeks)
- Change of fasting blood glucose (FBG) level(baseline, 12 weeks)
- Change of 2 hours postprandial blood glucose level(baseline, 12 weeks)
- Change of Percent of body fat (PBF) level(baseline, 12 weeks)
- Change of interleukin-6 (IL-6) level(baseline, 12 weeks)
- Change of hemoglobin level(baseline, 12 weeks)
- Change of total body fat level(baseline, 12 weeks)
- Change of triglyceride (TG) level(baseline, 12 weeks)
- Change of high density lipoprotein (HDL) cholesterol level(baseline, 12 weeks)
- Change of visceral fat area (VFA) level(baseline, 12 weeks)
研究者
Yu Kang, MD
Professor
Peking Union Medical College Hospital