1. Objectives: Previous studies have shown that serum zinc is lower in obese subjects and low serum zinc is associated with depression. The aim of the present study is to determine effects of zinc supplementation on mood, serum inflammatory factors and anthropometric indices in obese subjects.
2.Design: double blind randomized placebo controlled trial
3. Setting and conduct: Fifty obese subjects will be randomly allocated into two groups to receive daily either 30 mg zinc or placebo for 12 weeks. Ten milliliters of fasting blood samples will be collected at baseline and after intervention. Mood state, serum inflammatory factors and anthropometric indices will be measured at the baseline and after intervention.
4. Participants : Healthy obese subjects aged 18-35 years with a BMI≥ 30 Kg/Im² who are not pregnant and do not smoke.
5.Intervention: 30 mg zinc or placebo for 12 weeks
6.Main outcome measures variables: mood state, CRP, TNF-α, weight and body composition
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106122394N5
Registration date:2012-04-04, 1391/01/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-04, 1391/01/16
Registrant information
Name
Shima Jazayeri
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4805
Email address
sjazayeri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research, Tehran University of Medical Sciences
Expected recruitment start date
2011-01-02, 1389/10/12
Expected recruitment end date
2011-07-02, 1390/04/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of zinc supplementation on mood، serum inflammatory factors and antropometric indices in obese subjects
Public title
Effects of zinc supplementation on mood, serum inflammatory factors and antropometric indices in obese subjects
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Willing to participate; Age 18 to 35 years old;BMI≥ 30 Kg/m²;Being healthy;Not Taking any supplements or drugs during the previous 3 months;
Exclusion criteria:
Pregnancy; lactation;Smoking;
Age
From 18 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
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 Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd, Tehran, Iran.
City
Tehran
Postal code
Approval date
2011-12-25, 1390/10/04
Ethics committee reference number
13515
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
E66
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Mood
Timepoint
At baseline, after 12 weeks
Method of measurement
Beck Depression Inventory
2
Description
hsCRP
Timepoint
At baseline, after 12 weeks
Method of measurement
ELISA
3
Description
TNFα
Timepoint
At baseline, after 12 weks
Method of measurement
ELISA
4
Description
Weight
Timepoint
At baseline, after 12 weeks
Method of measurement
Weighting
5
Description
Body composition
Timepoint
At baseline, after 12 weeks
Method of measurement
Bioelectrical impedance analysis (BIA)
Secondary outcomes
empty
Intervention groups
1
Description
Zinc supplement: 30mg daily, after lunch for 12 weeks
Category
Prevention
2
Description
Placebo:
one tablet daily, after lunch, for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences
Full name of responsible person
Zahra Solati, Master Student
Street address
Tehran University of Medical Sciences, Pour Sina St., Enghelab Sq.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Tehran University of Mdical Sciences, Ghods Street, Keshavarz Blvd, Tehran, Iran
City
Tehran
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, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Solati
Position
Student
Other areas of specialty/work
Street address
First Floor, Number14, Isar St., Golestan St., Minicity.
City
Tehran
Postal code
1955756353
Phone
+98 21 2244 2709
Fax
Email
zahra.solaty@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shima Jazayeri
Position
Assisstant Professor
Other areas of specialty/work
Street address
Tehran University of Medical Science Faculty of Health, Alvand Avenue,Argentina Square
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
sh_jazayeri@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shima Jazayeri
Position
Assistant Professor
Other areas of specialty/work
Street address
Tehran University of Medical Science Faculty of Health, Alvand Avenue,Argentina Square
City
Tehran
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)