Chronic DiseaseNCT04690075
Effect of Dietary Fiber on Metabolism, Inflammation and Nutritional Status in Patients With Chronic Diseases
A study testing Nutrition Management and Dietary Fiber and Nutrition Management in people with Chronic Disease and Dietary Fiber, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Disease, Dietary Fiber
- What is being tested?
- Nutrition Management and Dietary Fiber and Nutrition Management
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70y
- Be diagnosed with obesity, hyperlipemia or hyperglycemia
- Fully understood and voluntarily signed the informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Kang Yu, M.D., +86 01-69155550, yuk1997@sina.com
Fang Wang, M.D., +8615201646084, yours.fang@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Disease, Dietary Fiber
- Being tested
- Nutrition Management and Dietary Fiber, Nutrition Management
- Keywords
- dietary fiber, chronic disease, metabolism, inflammation, nutritional status
- Medical subject headings
- Chronic Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition Management and Dietary FiberDietary supplement
Routine nutrition management and dietary fiber supplements based on recommendation for 12 weeks.
Nutrition ManagementDietary supplement
Routine nutrition management for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | To receive routine nutrition management and dietary fiber supplements based on recommendation for 12 weeks. Receives: Dietary Supplement: Nutrition Management and Dietary Fiber |
| Control | Placebo comparator | To receive routine nutrition management for 12 weeks. Receives: Dietary Supplement: Nutrition Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of total cholesterol (TC) level
Total cholesterol (TC) level obtained from laboratory test
Measured: baseline, 12 weeks
Change of low density lipoprotein (LDL) cholesterol level
Low density lipoprotein (LDL) cholesterol level obtained from laboratory test
Measured: baseline, 12 weeks
Secondary outcomes (10)
Change of interleukin-6 (IL-6) level
Interleukin-6 (IL-6) level obtained from laboratory test
Measured: baseline, 12 weeks
Change of tumor necrosis factor-alpha level
Change of tumor necrosis factor-alpha level obtained from laboratory test
Measured: baseline, 12 weeks
Change of triglyceride (TG) level
Change of triglyceride (TG) level obtained from laboratory test
Measured: baseline, 12 weeks
Change of high density lipoprotein (HDL) cholesterol level
Change of high density lipoprotein (HDL) cholesterol level obtained from laboratory test
Measured: baseline, 12 weeks
Change of fasting blood glucose (FBG) level
Change of fasting blood glucose (FBG) level obtained from laboratory test
Measured: baseline, 12 weeks
Change of 2 hours postprandial blood glucose level
Change of 2 hours postprandial blood glucose level obtained from laboratory test
Measured: baseline, 12 weeks
Change of hemoglobin level
Change of hemoglobin level obtained from laboratory test
Measured: baseline, 12 weeks
Change of total body fat level
Change of total body fat level obtained from bioelectrical impedance analysis
Measured: baseline, 12 weeks
Change of Percent of body fat (PBF) level
Change of percent of body fat (PBF) level obtained from bioelectrical impedance analysis
Measured: baseline, 12 weeks
Change of visceral fat area (VFA) level
Change of visceral fat area (VFA) level obtained from bioelectrical impedance analysis
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start24 Dec 2020
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Kang, MD, Peking Union Medical College Hospital
- Investigators
- Kang Yu, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690075
- Sponsor's protocol ID
- DFiber-CD-2020-2021
- Status last verified
- Jan 2021
- First submitted
- 14 Dec 2020
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28655017Baigent 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.
PubMed 16214597Ren 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.
PubMed 20223457Pop-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.
PubMed 27999003Nutrition recommendations and principles for people with diabetes mellitus. American Diabetes Association. J Fla Med Assoc. 1998 Aug;85(2):25-9.
PubMed 9782716Holman 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.
PubMed 18784090
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Fiber in Nutritional Therapy for Chronic Diseases
- ClinicalTrials.gov ID
- NCT04690075
- Acronym / sponsor ID
- DFiber-CD-2020-2021
- Conditions
- Chronic Disease, Dietary Fiber
- Keywords
- dietary fiber, chronic disease, metabolism, inflammation, nutritional status
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 24 Dec 2020 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Nutrition Management and Dietary FiberTo receive routine nutrition management and dietary fiber supplements based on recommendation for 12 weeks. |
| Control | Placebo comparator | Dietary Supplement: Nutrition ManagementTo receive routine nutrition management for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-70y
- Be diagnosed with obesity, hyperlipemia or hyperglycemia
- Fully understood and voluntarily signed the informed consent
Key exclusion criteria (7 listed)
- Secondary hyperlipidemia or hyperglycemia
- Multiple organ failure
- Allergic or intolerant to dietary fiber(dietary supplement)
- Have gastrointestinal diseases
- Have a history of abdominal diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition Management and Dietary FiberRoutine nutrition management and dietary fiber supplements based on recommendation for 12 weeks. | Dietary supplement | Intervention |
| Nutrition ManagementRoutine nutrition management for 12 weeks. | Dietary supplement | Control |
Primary outcome
Change of total cholesterol (TC) level
Time frame: baseline, 12 weeks
Total cholesterol (TC) level obtained from laboratory test
Change of low density lipoprotein (LDL) cholesterol level
Time frame: baseline, 12 weeks
Low density lipoprotein (LDL) cholesterol level obtained from laboratory test
10 secondary outcomes
Change of interleukin-6 (IL-6) level
Time frame: baseline, 12 weeks
Change of tumor necrosis factor-alpha level
Time frame: baseline, 12 weeks
Change of triglyceride (TG) level
Time frame: baseline, 12 weeks
Change of high density lipoprotein (HDL) cholesterol level
Time frame: baseline, 12 weeks
Change of fasting blood glucose (FBG) level
Time frame: baseline, 12 weeks
Change of 2 hours postprandial blood glucose level
Time frame: baseline, 12 weeks
Change of hemoglobin level
Time frame: baseline, 12 weeks
Change of total body fat level
Time frame: baseline, 12 weeks
Change of Percent of body fat (PBF) level
Time frame: baseline, 12 weeks
Change of visceral fat area (VFA) level
Time frame: baseline, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Background: PubMed 28655017Wang 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.
- Background: PubMed 16214597Baigent 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.
- Background: PubMed 20223457Ren 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.
- Background: PubMed 27999003Pop-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.
- Background: PubMed 9782716Nutrition recommendations and principles for people with diabetes mellitus. American Diabetes Association. J Fla Med Assoc. 1998 Aug;85(2):25-9.
- Background: PubMed 18784090Holman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kang Yu, M.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Management and Dietary Fiber and Nutrition Management in people with Chronic Disease and Dietary Fiber, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kang Yu, M.D. (+86 01-69155550, yuk1997@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of total cholesterol (TC) level (time frame: baseline, 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04690075, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.