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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04690075
Other study ID # DFiber-CD-2020-2021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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