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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Dietary Fiber; Chronic Disease

Treatments: Dietary Supplement: Nutrition Management; Dietary Supplement: Nutrition Management and Dietary Fiber

Study type: Interventional

Funder types: Other

Identifiers

NCT04690075

DFiber-CD-2020-2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

To receive routine nutrition management and dietary fiber supplements based on recommendation for 12 weeks.

Treatment:

Dietary Supplement: Nutrition Management and Dietary Fiber

Control

Placebo Comparator group

Description:

To receive routine nutrition management for 12 weeks.

Treatment:

Dietary Supplement: Nutrition Management