Protocol summary

Study aim
Determination of the Effect of Chicory Extract on Non-Alcoholic Fatty Liver
Design
In this study, 60 eligible non-alcoholic fatty liver participants who are referred to the Gastroenterology Clinic of Velayat Hospital, Qazvin are selected.The participants are then randomly assigned to intervention and control groups and each person is assigned a code and will receive an intervention (Chicory or placebo) based on the group.
Settings and conduct
This study was designed with the aim of helping to treatment patients with non-alcoholic fatty liver in a randomized, double-blind, placebo-controlled clinical trial. In this study, 60 patients with non-alcoholic fatty liver referred to the Gastroenterology Clinic of Velayat hospital, Qazvin province will study based on the criteria for entry. For all participants, a biochemical test (fasting blood glucose, total cholesterol, triglyceride, HDL, LDL, ALT, AST, alkaline phosphatase) will be performed in a specific laboratory at the beginning of the study. Meanwhile, liver and bile duct ultrasonography will be performed to determine the degree of fatty liver in a radiological center under the supervision of a specific radiologist. Anthropometric measurements including weight, height and waist circumference will be measured. Participants are then randomly assigned to either a case or control group, and will receive chicory capsules (case group) or placebo (control group) for 12 weeks. Biochemistry tests and other measurements will be repeated 6 weeks after the intervention and at the end of 12 weeks. The liver and bile duct ultrasonography will again performed at the end of 12 weeks. Finally, using statistical analysis, we will investigate the effect of chicory extract on non-alcoholic fatty liver disease.
Participants/Inclusion and exclusion criteria
Samples will be selected from people with non-alcoholic fatty liver disease of both genders and aged 18 to 65 years. If there are other causes of liver disease, pregnancy, lactation, malignancy, cardiovascular disease, diabetes, hypothyroidism, taking hepatotoxic drugs or drugs using for NAFLD management, the person will be excluded from the study.
Intervention groups
The study include 30 non-alcoholic fatty liver patients in the case group that will receive two 500 mg capsules of chicory extract per day, for 12 weeks. Also, 30 non-alcoholic fatty liver patients will be in the control group receiving 2 capsules of 500 mg per day for 12 weeks in the same way as the case group and containing starch as a placebo.
Main outcome variables
grade of fatty liver disease; serum aminotransferases levels; fasting plasma glucose ; lipid profile

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171216037911N1
Registration date: 2018-01-03, 1396/10/13
Registration timing: retrospective

Last update: 2018-01-03, 1396/10/13
Update count: 0
Registration date
2018-01-03, 1396/10/13
Registrant information
Name
Mahsa Asar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3368 7126
Email address
mahsa_assar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-12-20, 1395/09/30
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
2016-12-20, 1395/09/30
Actual recruitment end date
2017-12-13, 1396/09/22
Trial completion date
empty
Scientific title
The effects of aqueous extract of Cichorium Intybus L on non-aloholic fatty liver disease
Public title
The effects of Cichorium fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
diagnosis of NAFLD according to ultra-sonography age between 18 to 65 years increase SGPT leve more than 30mgr/dl
Exclusion criteria:
Other causes of liver disease, including viral hepatitis or autoimmune, high alcohol consumption (more than 210 g / week in men and more than 140 g / week in women), Wilson's disease, hereditary hemochematosus, alpha1-antitrypsin deficiency and cirrhosis gestation and lactation; diagnosis of cancers consumption of hepatotoxic drugs or drugs using for management of NAFLD diagnosis of cardiovascular diseases diagnosis of diabetes mellitus diagnosis of hypothyroidism
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Actual sample size reached: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible participants in the study will randomly assign to two intervention and control groups. A randomized, stratified sampling method will use to control the confounding factors (age and gender) and the samples will first divide into two sex groups (male and female) and then will categorize again in each group based on age (less than 35 years and more than 35 years). Finally, the samples in each class will be randomly assigned to intervention or control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Each participant is randomly assigned a colored card (green for the case and blue for the control group). Participants are informed that they may be in either case and control group and finally, members of the control group will receive Chicory if they want it. Principle investigator does not know the meaning of colored cards.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commitee of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blv, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2017-11-29, 1396/09/08
Ethics committee reference number
IR.QUMS.REC.1396.334

Health conditions studied

1

Description of health condition studied
nonalcoholic fatty liver disease
ICD-10 code
K76
ICD-10 code description
Other diseases of liver

Primary outcomes

1

Description
grade of fatty liver
Timepoint
before & 12 weeks after intervention
Method of measurement
liver and bile duct supersonic graphy

2

Description
Aspartate aminotransferases
Timepoint
before intervention, 6 weeks after beginning of the intervention, 12 weeks after beginning of the intervention
Method of measurement
blood sample

3

Description
waist circumfrence
Timepoint
before intervention, 6 weeks after beginning of the intervention, 12 weeks after beginning of the intervention
Method of measurement
by using of meter

Secondary outcomes

1

Description
serum Alanine Aminotransferase
Timepoint
before intervention, 6 weeks after beginning of the intervention, 12 weeks after beginning of the intervention
Method of measurement
blood sample

2

Description
serum ALP
Timepoint
before intervention, 6 weeks after beginning of the intervention, 12 weeks after beginning of the intervention
Method of measurement
blood sample

3

Description
weight
Timepoint
before intervention, 6 weeks after beginning of the intervention, 12 weeks after beginning of the intervention
Method of measurement
Mechanical scale

4

Description
serum triglyceride
Timepoint
before intervention, 6 weeks after beginning of the intervention, 12 weeks after beginning of the intervention
Method of measurement
blood sample

5

Description
Total cholestrol
Timepoint
before intervention, 6 weeks after beginning of the intervention, 12 weeks after beginning of the intervention
Method of measurement
blood sample

6

Description
serum HDL
Timepoint
before intervention, 6 weeks after beginning of the intervention, 12 weeks after beginning of the intervention
Method of measurement
blood sample

7

Description
serum LDL-C
Timepoint
before intervention, 6 weeks after beginning of the intervention, 12 weeks after beginning of the intervention
Method of measurement
blood sample

8

Description
fasting plasma glucose
Timepoint
before intervention, 6 weeks after beginning of the intervention, 12 weeks after beginning of the intervention
Method of measurement
blood sample

Intervention groups

1

Description
Intervention group: They will receive powder of aqueous extracts of 15 g chicory (equivalent to 1 g of extract) prepared by Avigeh Tejarat Sepehr Co. as two 500 mg capsules daily, for 12 weeks.
Category
Treatment - Drugs

2

Description
Control group: The control group will receive daily 1 g of starch as placebo in the form of two 500 mg capsules similar to Chicory capsules for 12 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastroenterology Clinic of Velayat Hospital
Full name of responsible person
Mahsa Asar
Street address
Minoodar district
City
Qazvin
Province
Qazvin
Postal code
3471976160
Phone
+98 28 3379 0620
Email
m.asar@qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Amir Peymani
Street address
Dept of research Qazvin University of Medical Shahid Beheshti, Ave' 3415613911 Qazvin' IRAN Sciences
City
Qazvin
Province
Qazvin
Postal code
13911/34156
Phone
+98 28 7777 3333
Email
apeymani@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mahsa Asar
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Shahid Beheshti, Ave. Sciences
City
Qazvin
Province
Qazvin
Postal code
3471976160
Phone
+98 28 3335 6696
Email
m.asar@qums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Ali Bastani
Position
Consultant
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterologist
Street address
Velayat hospital, Minoodar Distric
City
Qazvin
Province
Qazvin
Postal code
3471976160
Phone
+98 28 3335 6696
Email
a.bastani@qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mahsa Asar
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Shahid Beheshti Ave., Qazvin University of Medical sciences
City
Qazvin
Province
Qazvin
Postal code
3471976160
Phone
+98 28 3335 6696
Email
m.asar@qums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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