NCT04690075

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

December 24, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

January 8, 2021

Status Verified

January 1, 2021

Enrollment Period

4 months

First QC Date

December 14, 2020

Last Update Submit

January 6, 2021

Conditions

Chronic DiseaseDietary Fiber

Keywords

dietary fiberchronic diseasemetabolisminflammationnutritional status

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (10)

  • Change of interleukin-6 (IL-6) level

    baseline, 12 weeks

  • Change of tumor necrosis factor-alpha level

    baseline, 12 weeks

  • Change of triglyceride (TG) level

    baseline, 12 weeks

  • Change of high density lipoprotein (HDL) cholesterol level

    baseline, 12 weeks

  • Change of fasting blood glucose (FBG) level

    baseline, 12 weeks

  • +5 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Dietary Supplement: Nutrition Management and Dietary Fiber

Control

PLACEBO COMPARATOR

To receive routine nutrition management for 12 weeks.

Dietary Supplement: Nutrition Management

Interventions

Nutrition Management and Dietary FiberDIETARY_SUPPLEMENT

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

Intervention
Nutrition ManagementDIETARY_SUPPLEMENT

Routine nutrition management for 12 weeks.

Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70y
  • Be diagnosed with obesity, hyperlipemia or hyperglycemia
  • Fully understood and voluntarily signed the informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 28655017BACKGROUND

  • 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.

    PMID: 16214597BACKGROUND

  • 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.

    PMID: 20223457BACKGROUND

  • 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.

    PMID: 27999003BACKGROUND

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

    PMID: 9782716BACKGROUND

  • 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.

    PMID: 18784090BACKGROUND

MeSH Terms

Conditions

Chronic DiseaseInflammation

Interventions

Nutrition TherapyDietary Fiber

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsDietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Kang Yu, M.D.

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kang Yu, M.D.

CONTACT

+86 01-69155550yuk1997@sina.com

Xiaodong Nie, Dr

CONTACT

+8615832108663drdoranie@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 14, 2020

First Posted

December 30, 2020

Study Start

December 24, 2020

Primary Completion

April 30, 2021

Study Completion

June 30, 2021

Last Updated

January 8, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)