Effect of Coenzyme Q10 on serum levels of inflammatory markers, liver enzymes, leptin and adiponectin in patients with non alcoholic fatty liver disease
The purpose of this study was to investigate the effect of Coenzyme Q10 on serum levels of inflammatory markers, liver enzymes, leptin, adiponectin in patients with non alcoholic fatty liver disease. This Controlled, double-blind, randomized clinical trial was performed on 40 patients. Patients were randomly divided into 2 groups: The case and control group received CoQ10 supplement (100 mg per day) and starch (100 mg per day) as placebo respectively, for 3 months. Variables including anthropometric indicators, blood pressure, inflammatory markers, liver enzymes, fasting blood sugar and lipid profile were measured before and after of intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013071313984N1
Registration date:2013-12-18, 1392/09/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-12-18, 1392/09/27
Registrant information
Name
Farnaz Farsi
Name of organization / entity
School of Paramedicine, Ahvaz Jondishapur University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1416 2364
Email address
farsi.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Ahvaz jundishapur University of Medical Sciences
Expected recruitment start date
2012-05-15, 1391/02/26
Expected recruitment end date
2013-01-12, 1391/10/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Coenzyme Q10 on serum levels of inflammatory markers, liver enzymes, leptin and adiponectin in patients with non alcoholic fatty liver disease
Public title
Non alcoholic fatty liver disease and Coenzyme Q10
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 19-59 years old patient with non alcoholic fatty liver disease Exclusion criteria: Patients who have diabetes, cardiovascular, kidney and other hepatic diseases; Pregnant or lactating women; Smoking; Alcohol consumption; Use of dietary supplements.
Age
From 19 years old to 59 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Jondishapur University Of Medical Sciences, Golestan Ave. Ahvaz
City
Ahvaz
Postal code
6165777696
Approval date
2012-04-29, 1391/02/10
Ethics committee reference number
ETH-493
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
Aspartate aminotransferase
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Photometric
2
Description
Alanine aminotransferase
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Photometric
3
Description
Interlukine-6
Timepoint
Before intervention and 3 months after intervention
Method of measurement
ELISA
4
Description
hs-CRP
Timepoint
Before intervention and 3 months after intervention
Method of measurement
ELISA
5
Description
Gamma-glutamyl transpeptidase
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Photometric
6
Description
TNF-α
Timepoint
Before intervention and 3 months after intervention
Method of measurement
ELISA
7
Description
Adiponectin
Timepoint
Before intervention and 3 months after intervention
Method of measurement
ELISA
8
Description
Leptin
Timepoint
Before intervention and 3 months after intervention
Method of measurement
ELISA
9
Description
Fasting blood sugar
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Photometric
10
Description
LDL-C
Timepoint
Before intervention and 3 months after intervention
Method of measurement
undirected method with Friedewald
11
Description
Total cholestrol
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Photometric
12
Description
HDL-C
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Enzymatic
13
Description
Triglyciride
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Photometric
14
Description
VLDL
Timepoint
Before intervention and 3 months after intervention
Method of measurement
TG/5
Secondary outcomes
1
Description
Hip circumference
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Meter
2
Description
Waist circumference
Timepoint
Before intervention, 3 month after intervention
Method of measurement
Meter
3
Description
Blood pressure
Timepoint
Before intervention and 3 month after intervention
Method of measurement
Blood Pressure Monitor
4
Description
Body mass index
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Body weight in kilograms divided by height squared in meters
5
Description
Body weight
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Digital scale
Intervention groups
1
Description
Intervention group: daily consumption of 100 milligram coenzyme Q10 supplement for 3 months
Category
Treatment - Drugs
2
Description
Control group: daily consumption of 100 milligram starch for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology Clinic of Imam Khomeini Hospital
Full name of responsible person
Farnaz Farsi
Street address
Ahvaz, Azadegan alley
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jondishapur University Of Medical Sciences
Full name of responsible person
Majid Karandish
Street address
Ahvaz Jondishapur University Of Medical Sciences, Golestan Ave. Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz Jondishapur 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
School of Paramedicine, Ahvaz Jondishapur University Of Medical Sciences
Full name of responsible person
Farnaz Farsi
Position
Ms. in Nutrition sciences
Other areas of specialty/work
Street address
Ahvaz Jondishapur University of Medical Sciences, Golestan Ave. Ahvaz
City
Ahvaz
Postal code
6165777696
Phone
+98 611416236
Fax
+98 61 1224 0568
Email
farsi.f@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Paramedicine, Ahvaz Jondishapur University of Medical Sciences
Full name of responsible person
Majid Mohamadshahi
Position
PhD. in Nutrition sciences
Other areas of specialty/work
Street address
Ahvaz Jodishapur University of Medical Sciences, Golestan Ave. Ahvaz
City
Ahvaz
Postal code
Phone
+98 912 439 2836
Fax
Email
shahi334@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Paramedicine, Ahvaz Jodishapur University of Medical Sciences
Full name of responsible person
Farnaz Farsi
Position
Ms. in Nutrition Sciences
Other areas of specialty/work
Street address
Ahvaz Jondishapur University of Medical Sciences, Golestan Ave. Ahvaz
City
Ahvaz
Postal code
6165777696
Phone
+98 61 1416 2364
Fax
+98 61 1224 0568
Email
farsi.f@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)