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

January 6, 2021 updated by: Yu Kang, MD, Peking Union Medical College Hospital

Dietary Fiber in Nutritional Therapy for Chronic Diseases

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
To receive routine nutrition management and dietary fiber supplements based on recommendation for 12 weeks.
Dietary supplement: Nutrition Management and Dietary Fiber
Routine nutrition management and dietary fiber supplements based on recommendation for 12 weeks.
PLACEBO_COMPARATOR: Control
To receive routine nutrition management for 12 weeks.
Dietary supplement: Nutrition Management
Routine nutrition management for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of total cholesterol (TC) level
Time Frame: baseline, 12 weeks
Total cholesterol (TC) level obtained from laboratory test
baseline, 12 weeks
Change of low density lipoprotein (LDL) cholesterol level
Time Frame: baseline, 12 weeks
Low density lipoprotein (LDL) cholesterol level obtained from laboratory test
baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of interleukin-6 (IL-6) level
Time Frame: baseline, 12 weeks
Interleukin-6 (IL-6) level obtained from laboratory test
baseline, 12 weeks
Change of tumor necrosis factor-alpha level
Time Frame: baseline, 12 weeks
Change of tumor necrosis factor-alpha level obtained from laboratory test
baseline, 12 weeks
Change of triglyceride (TG) level
Time Frame: baseline, 12 weeks
Change of triglyceride (TG) level obtained from laboratory test
baseline, 12 weeks
Change of high density lipoprotein (HDL) cholesterol level
Time Frame: baseline, 12 weeks
Change of high density lipoprotein (HDL) cholesterol level obtained from laboratory test
baseline, 12 weeks
Change of fasting blood glucose (FBG) level
Time Frame: baseline, 12 weeks
Change of fasting blood glucose (FBG) level obtained from laboratory test
baseline, 12 weeks
Change of 2 hours postprandial blood glucose level
Time Frame: baseline, 12 weeks
Change of 2 hours postprandial blood glucose level obtained from laboratory test
baseline, 12 weeks
Change of hemoglobin level
Time Frame: baseline, 12 weeks
Change of hemoglobin level obtained from laboratory test
baseline, 12 weeks
Change of total body fat level
Time Frame: baseline, 12 weeks
Change of total body fat level obtained from bioelectrical impedance analysis
baseline, 12 weeks
Change of Percent of body fat (PBF) level
Time Frame: baseline, 12 weeks
Change of percent of body fat (PBF) level obtained from bioelectrical impedance analysis
baseline, 12 weeks
Change of visceral fat area (VFA) level
Time Frame: baseline, 12 weeks
Change of visceral fat area (VFA) level obtained from bioelectrical impedance analysis
baseline, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 24, 2020

Primary Completion (ANTICIPATED)

April 30, 2021

Study Completion (ANTICIPATED)

June 30, 2021

Study Registration Dates

First Submitted

December 14, 2020

First Submitted That Met QC Criteria

December 27, 2020

First Posted (ACTUAL)

December 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 8, 2021

Last Update Submitted That Met QC Criteria

January 6, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DFiber-CD-2020-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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