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

NCT ID: NCT04690075

Last Updated: 2021-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-24

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Disease Dietary Fiber

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Nutrition Management and Dietary Fiber

Intervention Type DIETARY_SUPPLEMENT

Routine nutrition management and dietary fiber supplements based on recommendation for 12 weeks.

Control

To receive routine nutrition management for 12 weeks.

Group Type PLACEBO_COMPARATOR

Nutrition Management

Intervention Type DIETARY_SUPPLEMENT

Routine nutrition management for 12 weeks.

Interventions

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Nutrition Management and Dietary Fiber

Routine nutrition management and dietary fiber supplements based on recommendation for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Nutrition Management

Routine nutrition management for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yu Kang, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kang Yu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kang Yu, M.D.

Role: CONTACT

+86 01-69155550

Xiaodong Nie, Dr

Role: CONTACT

+8615832108663

Facility Contacts

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Kang Yu, M.D.

Role: primary

+86 01-69155550

Fang Wang, M.D.

Role: backup

+8615201646084

References

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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.

Reference Type BACKGROUND
PMID: 28655017 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16214597 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20223457 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27999003 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 9782716 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18784090 (View on PubMed)

Other Identifiers

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DFiber-CD-2020-2021

Identifier Type: -

Identifier Source: org_study_id

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