This study is clinical trial. Obese and overweight individuals who live in Yazd participate in this study. Inclusion criteria: Body mass index (BMI) over 25 Kg / m2; men and women 20 to 50 years; without diabetes,CVD diseases; didn't heart surgery; lack of menopause; non smoking status; inactive (based on questionnaires) and Willing to participate in syudy. Exclusion criteria: don't use more than 20% drug that they have; unwillingness to do exercise; specific disease during study; smoking during study; menopause. They are assigned randomly to two groups (50 persons); intervention group consume 200 mcg Chromium Picolinate daily besides do 30 minutes exercise daily and control group just do exercise 30 minutes like intervention group. Every 14 days they receive their supplement. Measure BMI(Body Mass Composition) by Seca and tape meter, Fat Mass percent by Bc-418m1, TANITA, Japan instrument and serum Leptin by ELISA kit.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014012210826N6
Registration date:2014-01-29, 1392/11/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-29, 1392/11/09
Registrant information
Name
Azadeh Nadjarzadeh
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 202 2817
Email address
azadnajarzadeh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Science- Intrnational branch
Expected recruitment start date
2013-05-05, 1392/02/15
Expected recruitment end date
2013-08-11, 1392/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Chromium Picolinate supplementation on weight, fat mass and Leptin serum in obese and overweight peopel
Public title
Chromium Picolinate and Obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Body mass index (BMI) over 25 Kg / m2; men and women aged 20 to 50 years old; without diabetes, CVD; didn't heart surgery; lack of menopause; non smoking status; inactive (based on questionnaires) and willing to participate in study. Exclusion criteria: don't use more than 20% drug that they have; unwillingness to do exercise; specific disease during study; smoking during study; menopause.
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Science
Street address
International campus of Shahid Sadoughi University of Medical Science, 5th kilometer of Fahraj-Khavidak road, Yazd
City
Yazd
Postal code
Approval date
2013-06-10, 1392/03/20
Ethics committee reference number
48450
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified
Primary outcomes
1
Description
Weight
Timepoint
Before intervention and once a month after
Method of measurement
Scale with accuracy 100 gr
2
Description
Body Mass Index (BMI)
Timepoint
Before intervention and then once a month after
Method of measurement
Calculation: Weight (kg) / squared height (m)
3
Description
Waist
Timepoint
Before intervention and then once a month after
Method of measurement
Tape meter
4
Description
Body Fat Mass
Timepoint
Before intervention and once a month after
Method of measurement
Body Composition Instrument
5
Description
Serum leptin levels
Timepoint
Before and after intervation
Method of measurement
ELISA kit
Secondary outcomes
1
Description
Height
Timepoint
Before intervention and then once a month after
Method of measurement
Tape meter instaled on the wall
2
Description
Total energy intake
Timepoint
Before and after intervention
Method of measurement
24 hour recall
3
Description
Total charbohydate intake
Timepoint
Before and after intervention
Method of measurement
24 hour recall
4
Description
Total fat intake
Timepoint
Before and after intervention
Method of measurement
24 hour recall
5
Description
Total protein intake
Timepoint
Bafore and after intervention
Method of measurement
24 hour recall
6
Description
Total Chromium intake
Timepoint
Bafore and after intervention
Method of measurement
24 hour recall
Intervention groups
1
Description
In intrvention group, obese or overweight individuals, aged 20 to 50, will recieve a daily 200 mcg Chromium Picolinat and do 30 minutes exercise. The subjects are told not to change diet and life style.
Category
Treatment - Drugs
2
Description
In control group, obese and overweight individuals, aged 20-50 years, will recieve no intervention. The subjects are told not to change diet and life style.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi University of Medical Science
Full name of responsible person
Dr. Azade Najarzadeh
Street address
Health School, Daneshjoo Blvd,Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Science,International branch
Full name of responsible person
Dr. Mohammad Hasan Sheikhha
Street address
International campus of Shahid Sadoughi University of Medical Science, 5th kilometer of Fahraj-Khavidak road, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Science,International branch
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Science
Full name of responsible person
Dr. Hasan Mozaffari Khosravi
Position
PhD of Nutrition,professor
Other areas of specialty/work
Street address
Health School, Daneshjoo Blvd,Yazd
City
Yazd
Postal code
89156-887
Phone
+98 35 1624 5900
Fax
+98 35 1623 8555
Email
mozaffari.kh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Science-Intrnational branc
Full name of responsible person
Peyvand Robati
Position
Msc student of health science in nutrition
Other areas of specialty/work
Street address
International campus of Shahid Sadoughi University of Medical Science, 5th kilometer of Fahraj-Khavidak road, Yazd
City
Yazd
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)