The effect of oral Chromium picolinate supplementation on Liver Function, Oxidative Indicators, Leptin, Resisten, lipid profile, Blood Glucose Control Indicators, serum levels of Fetuin A and inflammatory factors in Non-Alcoholic Fatty Liver
Determine the effect of oral Chromium picolinate supplementation on Liver Function, Oxidative Indicators, Leptin, Resisten, lipid profile, Blood Glucose Control Indicators, serum levels of Fetuin A and inflammatory factors in Non-Alcoholic Fatty Liver (NAFLD)
Design
In this study, the target population will be people with NAFLD who were diagnosed and introduced by a gastroenterologist and ultrasound specialists and entered the study according to the criteria for entering the study and after obtaining written consent, randomly divided into two control and intervention groups.
Settings and conduct
This double-blind study is conducted at the Faculty of Nutrition Sciences of Tabriz University of Medical Sciences
Participants/Inclusion and exclusion criteria
Patients with NAFLD and lack of non-compliance characteristics
Intervention groups
Group intervention group receiving chromium picolinate and control group of starch corn.
Main outcome variables
Body mass index (BMI); age; duration of disease; history of drug use; diet; psychological stress; physical activity; Total cholesterol (TC); Triglyceride (TG); low density lipoprotein (LDL); High density lipoprotein (HDL); Plasma Atherosclerosis; Haemoglobin A1c (HbA1c) ; Insulin serum concentration; Fasting blood glucose; Insulin resistance index; Fetuin A; Tumour necrosis factor-α (TNF-α); High-sensitivity C-reactive protein (Hs-CRP); Interleukin 17 (IL-17); Alanine Aminotransferase (ALT); Aspartate Aminotransferase (AST); Alkaline Phosphatase (ALP) ; Superoxide Dismutase (SOD); Malondialdehyde (MDA); Glutathione Peroxidase (GPX); leptin; Resistin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100123003140N15
Registration date:2018-01-14, 1396/10/24
Registration timing:prospective
Last update:2018-01-14, 1396/10/24
Update count:0
Registration date
2018-01-14, 1396/10/24
Registrant information
Name
Bahram Pourghassem Gargari
Name of organization / entity
Health and Nutrition Faculty, Tabriz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1435 7580
Email address
pourghassemb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-20, 1396/10/30
Expected recruitment end date
2018-07-13, 1397/04/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral Chromium picolinate supplementation on Liver Function, Oxidative Indicators, Leptin, Resisten, lipid profile, Blood Glucose Control Indicators, serum levels of Fetuin A and inflammatory factors in Non-Alcoholic Fatty Liver
Public title
The effect of Chromium picolinate in Non-Alcoholic Fatty Liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who agree to participate in the study
Men and women aged 20 to 50 years
BMI ranges from 25 to 40 kg / m 2
Increased levels of ALT and AST are higher than normal levels
Grade 2, 3, and 4 diseases
Exclusion criteria:
kidney disease
Thyroid gland problems
Uncontrolled blood pressure
Taking statin
Hepatitis C and B
Cytomegalovirus
Pregnancy
alcohol consumption
Wilson
Hocromatosis
Deficiency of alpha-1 antitrypsin
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were randomly assigned to either one of the two groups of chromium picolinate or placebo using RAS software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are assigned codes and randomly divided into placebo and intervention groups. Both patients and us will not be aware of which patients will take placebo or supplement
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
No 2 Central Building, Tabriz University of Medical Science, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2018-01-01, 1396/10/11
Ethics committee reference number
IR.TBZMED.REC.1396.924
2
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
No 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2018-01-01, 1396/10/11
Ethics committee reference number
IR.TBZMED.REC.1396.925
Health conditions studied
1
Description of health condition studied
Non-alcoholic fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
LDL
Timepoint
First and three months after the start of the study
Method of measurement
Enzyme colorimetry
2
Description
HDL
Timepoint
First and three months after the start of the study
Method of measurement
Enzyme colorimetry
3
Description
TNF-α
Timepoint
First and three months after the start of the study
Method of measurement
ELISA Kit
Secondary outcomes
1
Description
Plasma Atherogen Index
Timepoint
Study beginning and 90 days after the start
Method of measurement
Triglyceride logarithmic formulation divided by high density lipoprotein
2
Description
BMI
Timepoint
First and six weeks after study
Method of measurement
Weight divided by second power of height
3
Description
Dietary intakes
Timepoint
First and 6 weeks after the start
Method of measurement
24-hour dietary recall inventory questionnaire
4
Description
Psychological stress
Timepoint
First and six weeks after the start of the study
Method of measurement
Holmes-and rahe scales questionnaire
5
Description
Insulin resistance index
Timepoint
First and three months after the studyفر
Method of measurement
Calculate Homeostatic model assessment
6
Description
The amount of physical activity
Timepoint
First and 6 weeks after study
Method of measurement
The International Physical Activity Questionnaire
7
Description
Waist circumference
Timepoint
First and Sixth Week
Method of measurement
measurement
8
Description
Boddy fat mass
Timepoint
First and Sixth Week
Method of measurement
Bioelectrical impedance analysis
9
Description
blood pressure
Timepoint
Frist and sixth week
Method of measurement
Digital monometer
10
Description
Chromium levels of blood
Timepoint
First and 3 months later study
Method of measurement
Spectrophotometry
11
Description
SOD
Timepoint
First and three months after the start of the study
Method of measurement
Biochemical kit
12
Description
ALP
Timepoint
First and three months after the start of the study
Method of measurement
Biochemical kit
13
Description
AST
Timepoint
First and three months after the start of the study
Method of measurement
Biochemical kit
14
Description
resistin
Timepoint
First and three months after the start of the study
Method of measurement
ELISA Kit
15
Description
Leptin
Timepoint
First and three months after the start of the study
Method of measurement
ELISA Kit
16
Description
MAD
Timepoint
First and three months after the start of the study
Method of measurement
Biochemical kit
17
Description
GPX
Timepoint
First and three months after the start of the study
Method of measurement
Biochemical kit
18
Description
ALT
Timepoint
First and three months after the start of the study
Method of measurement
Biochemical kit
19
Description
IL-17
Timepoint
First and three months after the start of the study
Method of measurement
ELISA kit
20
Description
Hs-CRP
Timepoint
First and three months after the start of the study
Method of measurement
ELISA Kit
21
Description
Concentration of Fetuin A
Timepoint
First and three months after the start of the study
Method of measurement
ELISA Kit
22
Description
Serum insulin concentration
Timepoint
First and three months after the start of the study
Method of measurement
ELISA Kit
23
Description
HbA1c
Timepoint
First and three months after the start of the study
Method of measurement
ELISA Kit
24
Description
TG
Timepoint
First and three months after the start of the study
Method of measurement
Enzyme colorimetry
25
Description
TC
Timepoint
First and three months after the start of the study
Method of measurement
Enzyme colorimetry
26
Description
Fasting blood sugar
Timepoint
First and three months after the start of the study
Method of measurement
Enzyme colorimetry
Intervention groups
1
Description
patients with NAFLD receiving 2 tablets of 200 microgram of chromium picolinate per day for 3 months. Delivery of medication to patients will be done every two weeks and it will be monitored during use by the phone for possible complications and continued use.
Category
Treatment - Other
2
Description
Control group:Patients with NAFLD who receive a placebo of corn starch tablets for two days each day for 3 months. Placebo will be delivered to patients every two weeks and will be monitored by the phone for potential side effects and continued use during use.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz International Hospital
Full name of responsible person
Manouchehr khoshbaten
Street address
Tabriz International Hospital, First Zaferanieh, Aflakat Square
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3332 8832
Email
mkhoshbaten@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Street address
Faculty of Nutrition and food science, Tabriz University of Medical Sciences, Golgasht st, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Email
ostadrahimi@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Bahram Pourghasem Gargari
Position
Faculty Member and Professor of Nutrition Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and food science, Tabriz University of Medical Sciences, Golgasht st, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3336 2117
Email
pourghassemb@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Bahram Pourghasem Gargari
Position
Faculty Member and Professor of Nutrition Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and food science, Tabriz University of Medical Sciences, Golgasht st, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7581
Email
pourghassemb@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Bahram Pourghasem Gargari
Position
Faculty Member and Professor of Nutrition Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and food science, Tabriz University of Medical Sciences, Golgasht st, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7581
Email
pourghassemb@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Publish primary and raw results of samples
When the data will become available and for how long
Then finish and publish the draft articles
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
With the permission of the researcher of the project and the sponsor of the project, the Nutrition Research Center and the Research Assistant of the University
From where data/document is obtainable
To the Nutrition Research Center - Scheme researchers
What processes are involved for a request to access data/document
In-person attendance and relevant permissions - phone call