Effect of Dietary Fiber on Metabolism, Inflammation and Nutritional Status in Patients With Chronic Diseases

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Dietary Fiber in Nutritional Therapy for Chronic Diseases

Conditions
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Chronic Disease, Dietary Fiber

Intervention / Treatment
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* Dietary Supplement: Nutrition Management and Dietary Fiber
* Dietary Supplement: Nutrition Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-70y Be diagnosed with obesity, hyperlipemia or hyperglycemia Fully understood and voluntarily signed the informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>To receive routine nutrition management and dietary fiber supplements based on recommendation for 12 weeks. | Dietary Supplement: Nutrition Management and Dietary Fiber<br>* Routine nutrition management and dietary fiber supplements based on recommendation for 12 weeks.<br>|
| Placebo Comparator: Control<br>To receive routine nutrition management for 12 weeks. | Dietary Supplement: Nutrition Management<br>* Routine nutrition management for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of total cholesterol (TC) level | Total cholesterol (TC) level obtained from laboratory test | baseline, 12 weeks | 
| Change of low density lipoprotein (LDL) cholesterol level | Low density lipoprotein (LDL) cholesterol level obtained from laboratory test | baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of interleukin-6 (IL-6) level | Interleukin-6 (IL-6) level obtained from laboratory test | baseline, 12 weeks | 
| Change of tumor necrosis factor-alpha level | Change of tumor necrosis factor-alpha level obtained from laboratory test | baseline, 12 weeks | 
| Change of triglyceride (TG) level | Change of triglyceride (TG) level obtained from laboratory test | baseline, 12 weeks | 
| Change of high density lipoprotein (HDL) cholesterol level | Change of high density lipoprotein (HDL) cholesterol level obtained from laboratory test | baseline, 12 weeks | 
| Change of fasting blood glucose (FBG) level | Change of fasting blood glucose (FBG) level obtained from laboratory test | baseline, 12 weeks | 
| Change of 2 hours postprandial blood glucose level | Change of 2 hours postprandial blood glucose level obtained from laboratory test | baseline, 12 weeks | 
| Change of hemoglobin level | Change of hemoglobin level obtained from laboratory test | baseline, 12 weeks | 
| Change of total body fat level | Change of total body fat level obtained from bioelectrical impedance analysis | baseline, 12 weeks | 
| Change of Percent of body fat (PBF) level | Change of percent of body fat (PBF) level obtained from bioelectrical impedance analysis | baseline, 12 weeks | 
| Change of visceral fat area (VFA) level | Change of visceral fat area (VFA) level obtained from bioelectrical impedance analysis | baseline, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dietary fiber, chronic disease, metabolism, inflammation, nutritional status