Protocol summary

Summary
This study aimed to evaluate the effects of quercetin supplementation on the lipid profile, liver enzymes, inflammatory markers and body composition in non alcoholic fatty liver diease. Inclusion criteria included: Failure to alcohol abuse; Body mass index equal to or greater than 25-40 Kg / m2; Lack of other acute and chronic liver diseases and disorders; No history of biliary tract disease in the past; Lack of acute heart disease,inherited disorders affecting liver condition and Exclusion criteria: Not wanting to continue working, diseases that require special treatment,Reduction of more than 10% of baseline body weight during the intervention period, not consumption of more than 10% of the supplements in any follow-up period and in general, any inconsistent with the inclusion criteria. This study will be conducted on On 110 men and women with with nonalcoholic fatty liver disease, In two supplement and placebo groups confirmed by ultrasound. Intervention patients, receive 500mg capsule supplement daily, morning and evening on an empty stomach, while the placebo group received placebo twice daily500mg capsule that looks like the original supplements. anthropometric Data collection (weight, height, body mass index, etc.) and body composition analysis using the bioelectrical impedence analysis will be measured four times during the study. 10 ml of venous blood will be taken of people at the beginning and end of the study in fasting,.Measuring lipid profile variables and liver enzymes by enzymatic methods and inflammatory markers such as: tumor necrosis factor alpha and c-reacrive protein also will be measured using ELISA method.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016060628299N1
Registration date: 2016-07-13, 1395/04/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-07-13, 1395/04/23
Registrant information
Name
Mahboobe Hosseinikia
Name of organization / entity
Kermanshah University of Medical Sciences, School of Public Health
Country
Iran (Islamic Republic of)
Phone
+98 83 3424 3452
Email address
m.hoseinikia@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
The cost of the project was paid entirely from the budget of Kermanshah University of Medical Sciences
Expected recruitment start date
2016-07-10, 1395/04/20
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of quercetin supplementation on liver enzymes, inflammation indices, lipid profile and body composition, acompaind by colori control in nonalcoholic fatty liver disease: A randomized, double-blind, pilot study
Public title
The effect of quercetin supplementation on nonalcoholic fatty liver disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria include: a willingness to participation; age 18-65 years; non-alcoholic fatty liver diagnosed by ultrasonography and liver function test Tests( Alanine transaminase and Aspartate transaminase (more than 30u/l in men and more than 20u/l in women)) ; Lack of alcohol abuse (taking more than 10 grams per day for women and more than 30 grams per day for men); Body mass index equal to or greater than 40Kg/M2; Lack of other acute and chronic liver disorders (hepatitis B and C, etc.); Wilson's disease; cirrhosis; no history of biliary tract disease; acute heart failure disease; renal; pulmonary; infectious diseases; diabetes; cancer; inherited disorders affecting liver condition (iron storage disease, etc.); the absence of pregnancy and lactation; disease related to thyroid disorders; No history of weight loss surgery in the past year; the absence of lose weight in the past three months and In general, lack of increase or decrease in weight regimes during the three months prior to sampling; Autoimmune diseases such as primary biliary cirrhosis, autoimmune hepatitis, sclerosing cholangitis; Non-use of antioxidant supplements during one month prior to sampling; Lack of use of effective drugs against weight during the three months prior to sampling; Do not use multivitamin-minerals and drugs that are most likely associated with this disease(Antiepileptic drugs, amiodarone, corticosteroids, phenytoin, lithium, roacutan, tamoxifen, methotrexate, aspirin, 5-fluorouracil, zidovudine, a synthetic estrogen, inhibitors of hydroxymethyl glutaryl coa reductase and etc);Lack of exposure to pesticides and insecticides such as: carbon tetrachloride; trichloroethylene; Avoiding the use of drugs that are likely to overlap with quercetin; including anticoagulants, inhibitors of CYP3A4 and .... Exclusion criteria included: Not wanting to continue working; diseases that require special treatment; Reduction of more than 10% of baseline body weight during the intervention period; not consumption of more than 10% of the supplements in any follow-up period and in general, any inconsistent with the inclusion criteria
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Building No. 2, Shahid Beheshti Boulevard, Kermanshah
City
Kermanshah
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
KUMS.REC.2016.79

Health conditions studied

1

Description of health condition studied
Non Alcoholic Fatty Liver Disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

Primary outcomes

1

Description
Lipid profile
Timepoint
at first and the end of study
Method of measurement
enzymathic method

2

Description
liver enzymes
Timepoint
at first and the end of study
Method of measurement
enzymathic method

3

Description
inflammatory markers
Timepoint
at first and the end of study
Method of measurement
ELISA method

Secondary outcomes

1

Description
body composition
Timepoint
at firt of the study and the end of forth,eighth and Twelfth weeks
Method of measurement
BIA

2

Description
weight
Timepoint
at firt of the study and the end of forth,eighth and Twelfth weeks
Method of measurement
With light clothing and using Seca scales with 100 gAccuracy

3

Description
height
Timepoint
Accuracy
Method of measurement
بدون کفش با استفاده از قد سنج سکا با دقت 0.1 سانتی متر

4

Description
Waist circumference
Timepoint
at firt of the study and the end of forth,eighth and Twelfth weeks
Method of measurement
Using a tape measure between the lowest gear and iliac crest with accuracy of 0.5 cm

5

Description
Hip circumference.
Timepoint
at firt of the study and the end of forth,eighth and Twelfth weeks
Method of measurement
Using a tape measure at the bigest part of the hips

Intervention groups

1

Description
Sigma quercetin supplements, 500 mg per day for 55 people in the intervention group for three monthsوBe taken on an empty stomach
Category
Treatment - Drugs

2

Description
placebo supplement containing starch but looks completely like the original supplementation for placebo group received 500 mg per day for 55 people for three months,Be taken on an empty stomach
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr.Nawabi Clinic
Full name of responsible person
Mahboobe Hosseibikia
Street address
Ejlaliye Building ,municipalStreet, Kermanshah
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Berooz Hamzeh
Street address
Building No. 2, Shahid Beheshti Boulevard, Kermanshah
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences, School of Public Health
Full name of responsible person
Mahboobe Hosseinikia
Position
MSc Student in nutritional Sciences
Other areas of specialty/work
Street address
Faculty of Health, ISAR Field next to Farabi Hospital
City
Kermanshah
Postal code
Phone
+98 83 3422 1215
Fax
Email
M.hosseinikia@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Health, ISAR Field next to Farabi Hospital, Kermanshah University of Medical Sciences
Full name of responsible person
Yahya Pasdar
Position
PhD in Nutrition Sciences
Other areas of specialty/work
Street address
Faculty of Health, ISAR Field next to Farabi Hospital
City
Kermanshah
Postal code
Phone
+98 83 3826 2005
Fax
Email
yahya.pasdar@kums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences, School of Public Health
Full name of responsible person
Mahboobe Hosseinikia
Position
MSc Student in nutritional Sciences
Other areas of specialty/work
Street address
Faculty of Health, ISAR Field next to Farabi Hospital
City
Kermanshah
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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