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

Not Applicable

• Conditions: Chronic Disease; Dietary Fiber
• Interventions: Dietary Supplement: Nutrition Management; Dietary Supplement: Nutrition Management and Dietary Fiber

• Registration Number: NCT04690075
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-12-14
• Study Start: 2020-12-24
• Study First Submitted QC: 2020-12-27
• Study First Posted: 2020-12-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-06
• Last Update Posted: 2021-01-08
• Primary Completion: 2021-04-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Nutrition Management	To receive routine nutrition management for 12 weeks.
Intervention	Nutrition Management and Dietary Fiber	To receive routine nutrition management and dietary fiber supplements based on recommendation for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change of total cholesterol (TC) level	baseline, 12 weeks	Total cholesterol (TC) level obtained from laboratory test
Change of low density lipoprotein (LDL) cholesterol level	baseline, 12 weeks	Low density lipoprotein (LDL) cholesterol level obtained from laboratory test

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China