Clinical trial NCT04690075: Effect of Dietary Fiber on Metabolism, Inflammation and Nutritional Status in Patients With Chronic Diseases
Official title: Dietary Fiber in Nutritional Therapy for Chronic Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Disease
Dietary Fiber
Keywords: dietary fiber
chronic disease
metabolism
inflammation
nutritional status
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of total cholesterol (TC) level
timeFrame: baseline, 12 weeks
measure: Change of low density lipoprotein (LDL) cholesterol level
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: Change of interleukin-6 (IL-6) level
timeFrame: baseline, 12 weeks
measure: Change of tumor necrosis factor-alpha level
timeFrame: baseline, 12 weeks
measure: Change of triglyceride (TG) level
timeFrame: baseline, 12 weeks
measure: Change of high density lipoprotein (HDL) cholesterol level
timeFrame: baseline, 12 weeks
measure: Change of fasting blood glucose (FBG) level
timeFrame: baseline, 12 weeks
measure: Change of 2 hours postprandial blood glucose level
timeFrame: baseline, 12 weeks
measure: Change of hemoglobin level
timeFrame: baseline, 12 weeks
measure: Change of total body fat level
timeFrame: baseline, 12 weeks
measure: Change of Percent of body fat (PBF) level
timeFrame: baseline, 12 weeks
measure: Change of visceral fat area (VFA) level
timeFrame: baseline, 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Kang Yu, M.D.
role: PRINCIPAL_INVESTIGATOR
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