This study is a randomized double-blind placebo controlled trial that subject with BMI=30-40 kg/m2 will be recruited from clinics of Tabriz university of medical science. The aim of the study is evaluation and comparison of zinc and omega 3 fatty acids supplementation on leptin level in obese peoples.
Patients will be divided randomly to 3 groups; zinc group, omega 3fatty acids and placebo. Zinc group receive 1 pill of zinc per day containing 30 mg, omega 3 fatty acid group receive 2 omega3 capsules with 1 g weight or 2 placebo capsules containing starch for a period of 30 day. Groups will not contact together. Anthropometric measurements (weight, height), biochemical criteria including plasma level of zinc and serum leptin using 5cc blood sample collected from patients, appetite evaluation, 3 dietary record will be measured before and after treatment and will be compared between three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112222017N5
Registration date:2012-01-10, 1390/10/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-01-10, 1390/10/20
Registrant information
Name
Alireza Ostadrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
ostadrahimi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Nutritional Research Center
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of zinc and omega 3 fatty acids supplementation on leptin level in obese peoples
Public title
Evaluation and comparison of zinc and omega 3 fatty acids supplementation on leptin level in obese peoples
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: BMI=30-40 and age 18-45 yrs. Exclusion criteria: Pregnancy and lactation; menopause; medical history of diabetes mellitus, liver, kidney and thyroid disorders; HIV disease; any interfering medication with lipid profile; receiving beta blocker medications, Omega3 fatty acids, vitamin A , iron, zinc and calcium supplementation; weight lowering drugs or special diet in the past 2 months and smoking.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Vice-chancellor for research-Tabriz University of Medical Science
Street address
Golgasht street, Tabriz.East Azarbayjan, Iran, Islamic Republic Of
City
Tabriz
Postal code
Approval date
2011-04-05, 1390/01/16
Ethics committee reference number
5.4.263
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Leptin
Timepoint
Baseline and at the end of intervention
Method of measurement
Radioimmunoassay (kit)
Secondary outcomes
1
Description
Nutritional status
Timepoint
Baseline and at the end of intervention
Method of measurement
Dietary record and food frequency questionnaire
2
Description
Plasma Zinc concentration
Timepoint
Baseline and at the end of intervention
Method of measurement
Atomic absorption spectrophotometry
3
Description
Appetite level
Timepoint
Baseline and at the end of intervention
Method of measurement
Visual analog scale questionnaire
4
Description
Anthropometric measurements
Timepoint
Baseline and at the end of intervention
Method of measurement
Analogue scale and meter
Intervention groups
1
Description
Intervention group1: 2 omega3 capsula with 1 gr weight(containing 180 mg EPA and 110 mg DHA)
for 30 day
Category
Treatment - Drugs
2
Description
1 zinc pill (containing 30 mg zinc) for 30 day
Category
Treatment - Drugs
3
Description
Placebo group: 2 capsule 1 g (containing 30 mg starch) for 30 day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics in Tabriz University of Medical Science
Full name of responsible person
Laleh payahoo
Street address
Golgasht street, Tabriz.East Azarbayjan , health and nutrition faculty, tabriz medical science university
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Rashidi
Street address
Tabriz University Of Medical Sciences, Tabriz, East Azarbaijan, Iran
City
Tabriz
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 of Tabriz 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
Tabriz university of medical science
Full name of responsible person
Laleh Payahoo
Position
MSc student in Nutrition
Other areas of specialty/work
Street address
Health and Nutrition faculty, Attare Neishabouri Avenue, Golgasht street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1335 2295
Fax
Email
llllpayahoo44@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical science
Full name of responsible person
Alireza Ostadrahimi
Position
Assistant professor in Nutrition
Other areas of specialty/work
Street address
Health and Nutrition faculty, Attare Neishabouri Avenue, Golgasht street, Tabriz, East Azarbayjan
City
Tabriz
Postal code
Phone
+98 41 1335 2295
Fax
Email
ostadrahimi@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Laleh Payahoo
Position
MSc student in Nutrition
Other areas of specialty/work
Street address
Health and Nutrition faculty, Attare Neishabouri Avenue, Golgasht street, Tabriz,East Azarbayjan
City
Tabriz
Postal code
Phone
+98 41 1335 2295
Fax
Email
llllpayahoo44@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)