Protocol summary

Summary
A total of 40 people with metabolic syndrome will be randomized in two groups: group 1 who will receive garlic tablets 1.8 gram/d (manufactured by Amin institute) and group 2 who will take placebo. 20 normal people matched in sex and age with the cases will enter in the study without any intervention as the second control group. All the subjects will fallow for 6 weeks. The personal information and data from physical exam will be collected and blood sampling for measurement of IL6, TNF alpha and Adiponectin will be done at the initiation and also the end of the study.

General information

Acronym
Garlic in Metabolic syndrome
IRCT registration information
IRCT registration number: IRCT138706121179N1
Registration date: 2009-01-01, 1387/10/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-01-01, 1387/10/12
Registrant information
Name
Faranak Sharifi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 1727 0815
Email address
zmdrc@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences, Metabolic Diseases Research Center
Expected recruitment start date
2008-06-21, 1387/04/01
Expected recruitment end date
2008-12-21, 1387/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of garlic tablets on serum concentrations of Adiponectin , INL6 and TNF alpha in subjects with metabolic syndrome
Public title
Effect of garlic on some types of adipokines in metabolic syndrome
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: All people who will be diagnosed to have metabolic syndrome based on ATPIII criteria , more than 18 years old. Exclusion criteria: Presence of acute or chronic inflammatory or infectious diseases, taking anti inflammatory medications or other drugs affecting insulin resistance.
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Zanjan University of Medical Sciences Ethics Committee
Street address
Azadi Boulevard
City
Zanjan
Postal code
77978-45157
Approval date
2007-09-20, 1386/06/29
Ethics committee reference number
19/3-3/2632

2

Ethics committee
Name of ethics committee
Street address
City
Postal code
Approval date
2011-10-09, 1390/07/17
Ethics committee reference number
11-312-11

Health conditions studied

1

Description of health condition studied
Metabolic Syndrome
ICD-10 code
E00-E90
ICD-10 code description
E65-E68

Primary outcomes

1

Description
serum Adiponectin
Timepoint
at the begining of the study and 6weeks after intervention
Method of measurement
ELISA

2

Description
serum TNF
Timepoint
at the begining of the study and 6weeks after intervention
Method of measurement
ELISA

3

Description
Serum IL6
Timepoint
at the begining of the study and 6weeks after intervention
Method of measurement
ELISA

Secondary outcomes

1

Description
serum lipid Concentrations(TG, Cholesterol, HDL-C)
Timepoint
at the begining of the study and 6weeks after intervention
Method of measurement
Enzymatic methods

2

Description
Fasting Plasma Glucose
Timepoint
at the begining of the study and 6weeks after intervention
Method of measurement
Enzymatic methods

3

Description
Blood pressure
Timepoint
at the begining of the study and 6weeks after intervention
Method of measurement
standard methods for BP

4

Description
waist circomferance
Timepoint
at the begining of the study and 6weeks after intervention
Method of measurement
standard methods

Intervention groups

1

Description
No intervention
Category
N/A

2

Description
Placebo
Category
empty

3

Description
Garlic tablets
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrine Clinic of Zanjan
Full name of responsible person
Faranak Sharifi
Street address
Vali-e-asr Hospital, Zanjan , Iran
City
Zanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan Metabolic Diseases Research Center, Zanjan university of medical sciences
Full name of responsible person
Alireza Biglari
Street address
Azadi Boulevard
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan Metabolic Diseases Research Center, Zanjan 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
Zanjan Metabolic Diseases Research Center
Full name of responsible person
Faranak Sharifi
Position
Associate Professor
Other areas of specialty/work
Street address
Vali-e-asr Hospital
City
Zanjan
Postal code
45157-77978
Phone
+98 24 1727 0815
Fax
+98 24 1727 0815
Email
faranaksharifi@hotmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan Metabolic Diseases Research Center
Full name of responsible person
Faranak Sharifi
Position
Subspeciality Board in Endocrinology
Other areas of specialty/work
Street address
Vali-e-asr Hospital
City
Zanjan
Postal code
45157-77978
Phone
+98 24 1727 0815
Fax
+98 24 1727 0815
Email
faranaksharifi@hotmail.comfaran1@zums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zanjan Metabolic Diseases Research Center
Full name of responsible person
Afagh Anjomshoaa
Position
MD
Other areas of specialty/work
Street address
Vali-e-asr Hospital
City
Zanjan
Postal code
45157-77978
Phone
+98 24 1727 0815
Fax
+98 24 1727 0815
Email
zmdrc@zums.ac.irafagh_anjomshoaa@yahoo.com
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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