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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | To receive routine nutrition management and dietary fiber supplements based on recommendation for 12 weeks. |
|
| Control | Placebo Comparator | To receive routine nutrition management for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition Management and Dietary Fiber | Dietary Supplement | Routine nutrition management and dietary fiber supplements based on recommendation for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of total cholesterol (TC) level | Total cholesterol (TC) level obtained from laboratory test | baseline, 12 weeks |
| Change of low density lipoprotein (LDL) cholesterol level | Low density lipoprotein (LDL) cholesterol level obtained from laboratory test | baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of interleukin-6 (IL-6) level | Interleukin-6 (IL-6) level obtained from laboratory test | baseline, 12 weeks |
| Change of tumor necrosis factor-alpha level | Change of tumor necrosis factor-alpha level obtained from laboratory test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kang Yu, M.D. | Contact | +86 01-69155550 | yuk1997@sina.com | |
| Xiaodong Nie, Dr | Contact | +8615832108663 | drdoranie@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kang Yu, M.D. | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28655017 | Background | 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. | |
| 16214597 | Background | 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. doi: 10.1016/S0140-6736(05)67394-1. Epub 2005 Sep 27. |
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| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
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| Nutrition Management | Dietary Supplement | Routine nutrition management for 12 weeks. |
|
| baseline, 12 weeks |
| Change of triglyceride (TG) level | Change of triglyceride (TG) level obtained from laboratory test | baseline, 12 weeks |
| Change of high density lipoprotein (HDL) cholesterol level | Change of high density lipoprotein (HDL) cholesterol level obtained from laboratory test | baseline, 12 weeks |
| Change of fasting blood glucose (FBG) level | Change of fasting blood glucose (FBG) level obtained from laboratory test | baseline, 12 weeks |
| Change of 2 hours postprandial blood glucose level | Change of 2 hours postprandial blood glucose level obtained from laboratory test | baseline, 12 weeks |
| Change of hemoglobin level | Change of hemoglobin level obtained from laboratory test | baseline, 12 weeks |
| Change of total body fat level | Change of total body fat level obtained from bioelectrical impedance analysis | baseline, 12 weeks |
| Change of Percent of body fat (PBF) level | Change of percent of body fat (PBF) level obtained from bioelectrical impedance analysis | baseline, 12 weeks |
| Change of visceral fat area (VFA) level | Change of visceral fat area (VFA) level obtained from bioelectrical impedance analysis | baseline, 12 weeks |
| 20223457 | Background | 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. |
| 27999003 | Background | 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. No abstract available. |
| 9782716 | Background | Nutrition recommendations and principles for people with diabetes mellitus. American Diabetes Association. J Fla Med Assoc. 1998 Aug;85(2):25-9. |
| 18784090 | Background | 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. |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |