Non-alcoholic Fatty Liver DiseaseNCT01875978

Effect of Phytosterols on Nonalcoholic Fatty Liver Disease

A study of Non-alcoholic Fatty Liver Disease, run by China Medical University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Phytosterols are plant sterols . Phytosterols have anti-inflammation effect. Investigators have a hypothesis: phytosterols reduce oxidative stress , enhance Insulin-like growth factor-1(IGF-1) and endothelial progenitor cells(EPCs). Therefore, phytosterols has novel role in cardiovascular protection. Read more about this study

Who is it for?: Ages 25 to 80 years
Conditions the study is for: Non-alcoholic Fatty Liver Disease
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteTaiwan
Study dates: Oct 2012to Jul 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 25 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

(1)25-80 years
(2)Fatty liver was diagnosed by abdominal echo by the same gastrologist, review by another gastrologist

Who cannot join

(1)Serological markers of hepatitis B virus(hepatitis B surface antigen and anti-HBs antibody) and hepatitis C virus infection (anti-HCV antibody)
(2)Autoimmune liver disease or alcoholic liver disease(alcohol intake more than 20g per day by using a questionnaire)
(3)Malignant diseases
(4)Pregnancy or breast feeding
(5)Clinical evidence of angina, congestive heart failure, valvular heart disease, inflammatory disease or thyroid dysfunction

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

China Medical University Hospital
Taichung

Other trials in Taiwan

About this study

Official title: Clinical Study of Phytosterols for Insulin-like Growth Factor-1 and Endothelial Progenitor Cell Levels in Patients With Nonalcoholic Fatty Liver Disease

Read the detailed description

Fatty liver is the hepatic feature of metabolic syndrome. Metabolic syndrome increase the risk of atherosclerosis and cardiovascular disease. Adipose tissue secrete adipocytes accumulate in the liver result in fatty liver. Excess fat become low density lipoprotein-cholesterol(LDL-C) from liver. Oxidized- LDL-C adherence in the vessel result in atherosclerosis via inflammation and immune response.

Phytosterols are present in the nuts, plant oil, broccoli and so on. The structure of phytosterols are similar with cholesterols. After the competition, the smaller absorption of cholesterols. Studies showed the average consumptions of phytosterols were 200mg daily but the enough amount for cardiovascular protection of phytosterols were 2000mg daily.

Daily 2000mg phytosterols inhibit the absorption of intestine, reduce the LDL-C about 7-10%. Besides, phytosterols have the effect of anti-inflammation and anti-immune response. The anti-inflammation effect obvious inhibit the monocyte to transform to macrophage, inhibit the formation of foam cell.

Clinical studies divided into two groups: 20/20 patients and 4 weeks follow up with cross-over test.First group A: Phytosterols 1800mg/day for 4 weeks ,washout 2 weeks, then placebo 4 weeks. Another group B: placebo 4 weeks, washout 2 weeks, then phytosterols 4 weeks.Cross-over, double blind study was designed.

Investigators check the possible benefits of LDL-C, Total -cholesterol,anti-oxidant capacity,C reactive protein,insulin-like growth factor-1, endothelial progenitor cells ; the possible side effect including liver function,muscle enzyme .

Conditions: Non-alcoholic Fatty Liver Disease
Being tested: Phytosterols & placebo
Keywords: Phytosterols, Endothelial progenitor cells
Medical subject headings: Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Phytosterols & placeboDietary supplement
Group A:Phytosterols 1.8g/day with one meal for 4 weeks first;group B:placebo first

Study groups in NCT01875978
Study group	Role	What they receive
Phytosterols & placebo	Active comparator	Group A:daily 1.8g phytosterols powder for 4 weeks first;group B:placebo for 4 weeks first Receives: Dietary Supplement: Phytosterols & placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease
1. Check serum metabolic status: levels in total cholesterol, low density lipoprotein-cholesterol, fasting glucose
2. Check serum anti-inflammatory status: levels in C reactive protein
Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols)
Measured: after 4 weeks phytosterols 1.8g/day
Anti-oxidative Capacity of Phytosterols on Patients With Fatty Liver Disease
Check serum anti-oxidative capacity, especially the serum superoxide dismutase (SOD) levels.Serum SOD provide the anti-oxidative capacity in lipid oxidation.
Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols)
Measured: after 4 weeks phytosterols 1.8g/day
Insulin-like Growth Factor-1 Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease
Check serum Insulin-like growth factor-1 levels. Serum Insulin-like growth factor-1 (IGF-1) influence metabolic status and reduce EPCs apoptosis via IGF-1 receptor.
Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols)
Measured: after 4 weeks phytosterols 1.8g/day
Endothelial Protective Effect of Phytosterols on Patients With Non-alcoholic Fatty Liver Disease
Ceck serum endothelial progenitor cells in the monocytes group but not in the lymphocytes group. Serum EPCs in the monocytes group provide the effect of endothelial repair to support novel vessel protection.
Cytometry flow check 150,000 cells per time including monocytes and lymphocytes group. Positive cells is the EPCs in the monocytes group. Stain with KDR, call kinase insert domain receptor, also call as VEGF receptor-2.
Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols)
Measured: after 4 weeks phytosterols 1.8g/day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2012Jul 2013

First posted12 Jun 2013 (estimated)
Study startOct 2012
Primary completionDec 2012
Study completionJul 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
More trials run by China Medical University 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: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01875978
Sponsor's protocol ID: DMR101-IRB2-036
Status last verified: May 2014
First submitted: 3 Jun 2013
Last updated: 11 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
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RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
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All Non-alcoholic Fatty Liver Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study of Phytosterols for Insulin-like Growth Factor-1 and Endothelial Progenitor Cell Levels in Patients With Nonalcoholic Fatty Liver Disease
ClinicalTrials.gov ID: NCT01875978
Acronym / sponsor ID: DMR101-IRB2-036
Conditions: Non-alcoholic Fatty Liver Disease
Keywords: Phytosterols, Endothelial progenitor cells
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: China Medical University HospitalUniversity, hospital or other
Study start: Oct 2012
Primary completion: Dec 2012 (actual)
Study completion: Jul 2013 (actual)
First posted: 12 Jun 2013 (estimated)
Results: Posted 11 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 1

Arm	Type	Receives
Phytosterols & placebo	Active comparator	Dietary Supplement: Phytosterols & placeboGroup A:daily 1.8g phytosterols powder for 4 weeks first;group B:placebo for 4 weeks first

Who may qualify

Ages: 25 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

(1)25-80 years
(2)Fatty liver was diagnosed by abdominal echo by the same gastrologist, review by another gastrologist

Key exclusion criteria (5 listed)

(1)Serological markers of hepatitis B virus(hepatitis B surface antigen and anti-HBs antibody) and hepatitis C virus infection (anti-HCV antibody)
(2)Autoimmune liver disease or alcoholic liver disease(alcohol intake more than 20g per day by using a questionnaire)
(3)Malignant diseases
(4)Pregnancy or breast feeding
(5)Clinical evidence of angina, congestive heart failure, valvular heart disease, inflammatory disease or thyroid dysfunction

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
Phytosterols & placeboGroup A:Phytosterols 1.8g/day with one meal for 4 weeks first;group B:placebo first	Dietary supplement	Phytosterols & placebo

Primary outcome

Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease
Time frame: after 4 weeks phytosterols 1.8g/day
1. Check serum metabolic status: levels in total cholesterol, low density lipoprotein-cholesterol, fasting glucose 2. Check serum anti-inflammatory status: levels in C reactive protein Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols)
Anti-oxidative Capacity of Phytosterols on Patients With Fatty Liver Disease
Time frame: after 4 weeks phytosterols 1.8g/day
Check serum anti-oxidative capacity, especially the serum superoxide dismutase (SOD) levels.Serum SOD provide the anti-oxidative capacity in lipid oxidation. Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols)
Insulin-like Growth Factor-1 Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease
Time frame: after 4 weeks phytosterols 1.8g/day
Check serum Insulin-like growth factor-1 levels. Serum Insulin-like growth factor-1 (IGF-1) influence metabolic status and reduce EPCs apoptosis via IGF-1 receptor. Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols)
Endothelial Protective Effect of Phytosterols on Patients With Non-alcoholic Fatty Liver Disease
Time frame: after 4 weeks phytosterols 1.8g/day
Ceck serum endothelial progenitor cells in the monocytes group but not in the lymphocytes group. Serum EPCs in the monocytes group provide the effect of endothelial repair to support novel vessel protection. Cytometry flow check 150,000 cells per time including monocytes and lymphocytes group. Positive cells is the EPCs in the monocytes group. Stain with KDR, call kinase insert domain receptor, also call as VEGF receptor-2. Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols)

Results and safety

Results posted to the registry on 11 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A:Phytosterols-placebo	20	20
Group B:Placebo-phytosterols	20	20

Primary outcome: Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease

Time frame: after 4 weeks phytosterols 1.8g/day. Mean (Standard Error). Unit: mg/dl

Measure	Group A:Phytosterols-placebo n = 20	Group B:Placebo-phytosterols n = 20
total cholesterol (baseline)	184.1 (6.54)	191.65 (8.74)
total cholesterol (mid-point)	174.60 (6.13)	199.25 (6.70)
total cholesterol (end-point)	180.55 (5.59)	188.60 (6.03)
low density lipoprotein (baseline)	110.33 (6.19)	118.45 (7.86)
low density lipoprotein (mid-point)	100.76 (5.96)	121.29 (6.10)
low density lipoprotein (end-point)	107.54 (5.05)	112.66 (5.46)
fating glucose (baseline)	106.23 (2.40)	105.01 (1.80)
fasting glucose (mid-point)	100.78 (1.88)	104.88 (2.04)

Group A:Phytosterols-placebo vs Group B:Placebo-phytosterols: p <0.05, t-test, 1 sided

Primary outcome: Anti-oxidative Capacity of Phytosterols on Patients With Fatty Liver Disease

Time frame: after 4 weeks phytosterols 1.8g/day. Mean (Standard Error). Unit: U/mg-protein

Measure	Group A:Phytosterols-placebo n = 20	Group B:Placebo-phytosterols n = 20
Serum SOD (baseline)	97.33 (2.67)	99.41 (2.39)
Serum SOD (mid-point)	104.91 (3.16)	95.1 (2.82)
Serum SOD (end-point)	103.28 (4.18)	106.54 (3.76)

Group A:Phytosterols-placebo vs Group B:Placebo-phytosterols: p <0.05, t-test, 1 sided

Primary outcome: Insulin-like Growth Factor-1 Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease

Time frame: after 4 weeks phytosterols 1.8g/day. Mean (Standard Error). Unit: ng/ml

Measure	Group A:Phytosterols-placebo n = 20	Group B:Placebo-phytosterols n = 20
Serum IGF-1 (baseline)	137.14 (8.36)	153.30 (10.44)
Serum IGF-1 (mid-point)	167.96 (9.42)	150.26 (9.37)
Serum IGF-1 (end-point)	165.23 (7.78)	178.04 (10.88)

Group A:Phytosterols-placebo vs Group B:Placebo-phytosterols: p <0.05, t-test, 1 sided

Primary outcome: Endothelial Protective Effect of Phytosterols on Patients With Non-alcoholic Fatty Liver Disease

Time frame: after 4 weeks phytosterols 1.8g/day. Mean (Standard Error). Unit: positive cells/150,000 cells

Measure	Group A:Phytosterols-placebo n = 20	Group B:Placebo-phytosterols n = 20
EPCs with CD34+ (baseline)	13.5 (2.38)	18.4 (2.58)
EPCs with CD34+ (mid-point)	23.35 (4.88)	18.4 (3.74)
EPCs with CD34+ (end-point)	18.7 (2.31)	28.25 (3.68)
EPCs with CD34+,KDR+ (baseline)	0.9 (0.26)	1.2 (0.31)
EPCs with CD34+,KDR+ (mid-point)	2.5 (0.34)	1.1 (0.16)
EPCs with CD34+,KDR+ (end-point)	2.05 (0.23)	2.5 (0.4)
EPCs with KDR+,CD133+ (baseline)	0.8 (0.24)	1.1 (0.3)
EPCs with KDR+,CD133+ (mid-point)	2.45 (0.31)	1.1 (0.16)

Group A:Phytosterols-placebo vs Group B:Placebo-phytosterols: p <0.05, t-test, 1 sided

Adverse events

Time frame: 2 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A: Phytosterols-placebo	0 of 20 (0%)	1 of 20 (5%)	Not reported
Group B: Placebo-phytosterols	0 of 20 (0%)	0 of 20 (0%)	Not reported

Limitations and caveats (from the sponsor): 1. The sample size of this study is small amount 2. Abdominal ultrasound related nonalcoholic fatty liver disease diagnosis is not compatible completely

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Non-alcoholic Fatty Liver Disease

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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.

Dalong Chen, M.D. principal investigator

China Medical University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Non-alcoholic Fatty Liver Disease, run by China Medical University Hospital at 1 site in Taiwan.

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 2 inclusion and 5 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: finished, as of the sponsor's last update on 11 Jun 2014. 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 Taiwan. 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. 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?

Yes. Results are posted in the registry (first posted 11 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease (time frame: after 4 weeks phytosterols 1.8g/day). The study lists 4 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 NCT01875978.

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 11 Jun 2014.