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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Routine nutrition management and dietary fiber supplements based on recommendation for 12 weeks.
Routine nutrition management for 12 weeks.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGChange of total cholesterol (TC) level
Total cholesterol (TC) level obtained from laboratory test
Time frame: baseline, 12 weeks
Change of low density lipoprotein (LDL) cholesterol level
Low density lipoprotein (LDL) cholesterol level obtained from laboratory test
Time frame: baseline, 12 weeks
Change of interleukin-6 (IL-6) level
Interleukin-6 (IL-6) level obtained from laboratory test
Time frame: baseline, 12 weeks
Change of tumor necrosis factor-alpha level
Change of tumor necrosis factor-alpha level obtained from laboratory test
Time frame: baseline, 12 weeks
Change of triglyceride (TG) level
Change of triglyceride (TG) level obtained from laboratory test
Time frame: baseline, 12 weeks
Change of high density lipoprotein (HDL) cholesterol level
Change of high density lipoprotein (HDL) cholesterol level obtained from laboratory test
Time frame: baseline, 12 weeks
Change of fasting blood glucose (FBG) level
Change of fasting blood glucose (FBG) level obtained from laboratory test
Time frame: baseline, 12 weeks
Change of 2 hours postprandial blood glucose level
Change of 2 hours postprandial blood glucose level obtained from laboratory test
Time frame: baseline, 12 weeks
Change of hemoglobin level
Change of hemoglobin level obtained from laboratory test
Time frame: baseline, 12 weeks
Change of total body fat level
Change of total body fat level obtained from bioelectrical impedance analysis
Time frame: baseline, 12 weeks
Change of Percent of body fat (PBF) level
Change of percent of body fat (PBF) level obtained from bioelectrical impedance analysis
Time frame: baseline, 12 weeks
Change of visceral fat area (VFA) level
Change of visceral fat area (VFA) level obtained from bioelectrical impedance analysis
Time frame: baseline, 12 weeks
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