Effect of Dietary Fiber on Metabolism, Inflammation and Nutritional Status in Patients With Chronic Diseases
Primary Purpose
Chronic Disease, Dietary Fiber
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nutrition Management and Dietary Fiber
Nutrition Management
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Disease focused on measuring dietary fiber, chronic disease, metabolism, inflammation, nutritional status
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
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
To receive routine nutrition management and dietary fiber supplements based on recommendation for 12 weeks.
To receive routine nutrition management for 12 weeks.
Outcomes
Primary Outcome Measures
Change of total cholesterol (TC) level
Total cholesterol (TC) level obtained from laboratory test
Change of low density lipoprotein (LDL) cholesterol level
Low density lipoprotein (LDL) cholesterol level obtained from laboratory test
Secondary Outcome Measures
Change of interleukin-6 (IL-6) level
Interleukin-6 (IL-6) level obtained from laboratory test
Change of tumor necrosis factor-alpha level
Change of tumor necrosis factor-alpha level obtained from laboratory test
Change of triglyceride (TG) level
Change of triglyceride (TG) level obtained from laboratory test
Change of high density lipoprotein (HDL) cholesterol level
Change of high density lipoprotein (HDL) cholesterol level obtained from laboratory test
Change of fasting blood glucose (FBG) level
Change of fasting blood glucose (FBG) level obtained from laboratory test
Change of 2 hours postprandial blood glucose level
Change of 2 hours postprandial blood glucose level obtained from laboratory test
Change of hemoglobin level
Change of hemoglobin level obtained from laboratory test
Change of total body fat level
Change of total body fat level obtained from bioelectrical impedance analysis
Change of Percent of body fat (PBF) level
Change of percent of body fat (PBF) level obtained from bioelectrical impedance analysis
Change of visceral fat area (VFA) level
Change of visceral fat area (VFA) level obtained from bioelectrical impedance analysis
Full Information
NCT ID
NCT04690075
First Posted
December 14, 2020
Last Updated
January 6, 2021
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04690075
Brief Title
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 24, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Dietary Fiber
Keywords
dietary fiber, chronic disease, metabolism, inflammation, nutritional status
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
To receive routine nutrition management and dietary fiber supplements based on recommendation for 12 weeks.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
To receive routine nutrition management for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrition Management and Dietary Fiber
Intervention Description
Routine nutrition management and dietary fiber supplements based on recommendation for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrition Management
Intervention Description
Routine nutrition management for 12 weeks.
Primary Outcome Measure Information:
Title
Change of total cholesterol (TC) level
Description
Total cholesterol (TC) level obtained from laboratory test
Time Frame
baseline, 12 weeks
Title
Change of low density lipoprotein (LDL) cholesterol level
Description
Low density lipoprotein (LDL) cholesterol level obtained from laboratory test
Time Frame
baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Change of interleukin-6 (IL-6) level
Description
Interleukin-6 (IL-6) level obtained from laboratory test
Time Frame
baseline, 12 weeks
Title
Change of tumor necrosis factor-alpha level
Description
Change of tumor necrosis factor-alpha level obtained from laboratory test
Time Frame
baseline, 12 weeks
Title
Change of triglyceride (TG) level
Description
Change of triglyceride (TG) level obtained from laboratory test
Time Frame
baseline, 12 weeks
Title
Change of high density lipoprotein (HDL) cholesterol level
Description
Change of high density lipoprotein (HDL) cholesterol level obtained from laboratory test
Time Frame
baseline, 12 weeks
Title
Change of fasting blood glucose (FBG) level
Description
Change of fasting blood glucose (FBG) level obtained from laboratory test
Time Frame
baseline, 12 weeks
Title
Change of 2 hours postprandial blood glucose level
Description
Change of 2 hours postprandial blood glucose level obtained from laboratory test
Time Frame
baseline, 12 weeks
Title
Change of hemoglobin level
Description
Change of hemoglobin level obtained from laboratory test
Time Frame
baseline, 12 weeks
Title
Change of total body fat level
Description
Change of total body fat level obtained from bioelectrical impedance analysis
Time Frame
baseline, 12 weeks
Title
Change of Percent of body fat (PBF) level
Description
Change of percent of body fat (PBF) level obtained from bioelectrical impedance analysis
Time Frame
baseline, 12 weeks
Title
Change of visceral fat area (VFA) level
Description
Change of visceral fat area (VFA) level obtained from bioelectrical impedance analysis
Time Frame
baseline, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kang Yu, M.D.
Phone
+86 01-69155550
Email
yuk1997@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaodong Nie, Dr
Phone
+8615832108663
Email
drdoranie@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kang Yu, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kang Yu, M.D.
Phone
+86 01-69155550
Email
yuk1997@sina.com
First Name & Middle Initial & Last Name & Degree
Fang Wang, M.D.
Phone
+8615201646084
Email
yours.fang@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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28655017
Citation
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Results Reference
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PubMed Identifier
16214597
Citation
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. Erratum In: Lancet. 2005 Oct 15-21;366(9494):1358. Lancet. 2008 Jun 21;371(9630):2084.
Results Reference
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PubMed Identifier
20223457
Citation
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Results Reference
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PubMed Identifier
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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. No abstract available.
Results Reference
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PubMed Identifier
9782716
Citation
Nutrition recommendations and principles for people with diabetes mellitus. American Diabetes Association. J Fla Med Assoc. 1998 Aug;85(2):25-9.
Results Reference
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PubMed Identifier
18784090
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.
Results Reference
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Effect of Dietary Fiber on Metabolism, Inflammation and Nutritional Status in Patients With Chronic Diseases
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