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

Chronic Disease Clinical Trial

Official title:

Dietary Fiber in Nutritional Therapy for Chronic Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04690075
• Other study ID #: DFiber-CD-2020-2021
• Status: Recruiting
• Phase: N/A
• Start date: December 24, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: January 2021
• Source: Peking Union Medical College Hospital
• Contact: Kang Yu, M.D.
• Phone: +86 01-69155550
• Email: yuk1997[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Dietary Fiber

Intervention

Dietary Supplement:
• Nutrition Management and Dietary Fiber
Routine nutrition management and dietary fiber supplements based on recommendation for 12 weeks.
• Nutrition Management
Routine nutrition management for 12 weeks.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

Baigent C, Keech A, Kearney PM, Blackwell L, Buck G, Pollicino C, Kirby A, Sourjina T, Peto R, Collins R, Simes R; Cholesterol Treatment Trialists' (CTT) Collaborators. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005 Oct 8;366(9493):1267-78. Epub 2005 Sep 27. Erratum in: Lancet. 2005 Oct 15-21;366(9494):1358. Lancet. 2008 Jun 21;371(9630):2084. — View Citation

Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008 Oct 9;359(15):1577-89. doi: 10.1056/NEJMoa0806470. Epub 2008 Sep 10. — View Citation

Nutrition recommendations and principles for people with diabetes mellitus. American Diabetes Association. J Fla Med Assoc. 1998 Aug;85(2):25-9. — View Citation

Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. Review. — View Citation

Ren J, Grundy SM, Liu J, Wang W, Wang M, Sun J, Liu J, Li Y, Wu Z, Zhao D. Long-term coronary heart disease risk associated with very-low-density lipoprotein cholesterol in Chinese: the results of a 15-Year Chinese Multi-Provincial Cohort Study (CMCS). Atherosclerosis. 2010 Jul;211(1):327-32. doi: 10.1016/j.atherosclerosis.2010.02.020. Epub 2010 Feb 21. — View Citation

Wang L, Gao P, Zhang M, Huang Z, Zhang D, Deng Q, Li Y, Zhao Z, Qin X, Jin D, Zhou M, Tang X, Hu Y, Wang L. Prevalence and Ethnic Pattern of Diabetes and Prediabetes in China in 2013. JAMA. 2017 Jun 27;317(24):2515-2523. doi: 10.1001/jama.2017.7596. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of total cholesterol (TC) level	Total cholesterol (TC) level obtained from laboratory test	baseline, 12 weeks
Primary	Change of low density lipoprotein (LDL) cholesterol level	Low density lipoprotein (LDL) cholesterol level obtained from laboratory test	baseline, 12 weeks
Secondary	Change of interleukin-6 (IL-6) level	Interleukin-6 (IL-6) level obtained from laboratory test	baseline, 12 weeks
Secondary	Change of tumor necrosis factor-alpha level	Change of tumor necrosis factor-alpha level obtained from laboratory test	baseline, 12 weeks
Secondary	Change of triglyceride (TG) level	Change of triglyceride (TG) level obtained from laboratory test	baseline, 12 weeks
Secondary	Change of high density lipoprotein (HDL) cholesterol level	Change of high density lipoprotein (HDL) cholesterol level obtained from laboratory test	baseline, 12 weeks
Secondary	Change of fasting blood glucose (FBG) level	Change of fasting blood glucose (FBG) level obtained from laboratory test	baseline, 12 weeks
Secondary	Change of 2 hours postprandial blood glucose level	Change of 2 hours postprandial blood glucose level obtained from laboratory test	baseline, 12 weeks
Secondary	Change of hemoglobin level	Change of hemoglobin level obtained from laboratory test	baseline, 12 weeks
Secondary	Change of total body fat level	Change of total body fat level obtained from bioelectrical impedance analysis	baseline, 12 weeks
Secondary	Change of Percent of body fat (PBF) level	Change of percent of body fat (PBF) level obtained from bioelectrical impedance analysis	baseline, 12 weeks
Secondary	Change of visceral fat area (VFA) level	Change of visceral fat area (VFA) level obtained from bioelectrical impedance analysis	baseline, 12 weeks