Effect of high protein diet on anthropometriC measeurements, cardiovascular disease risk factors and inflamatory markers among overweight and obese children was assessed. Obese or overweight girls and boys with ages of 6-11years were included in this study. The subjects not following the research protocols will be excluded. The requirement sample size is 50 subjects. This parallel study will be conducted in 10 weeks. high protein diet is administered to intervention group and control diet are administered to non-intervention group. At the end of the study, anthropometric variables, blood pressure, , adiponectin and lipid profile will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307232839N6
Registration date:2013-09-07, 1392/06/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-07, 1392/06/16
Registrant information
Name
Leila Azadbakht
Name of organization / entity
Nutrition department, School of health, Isfahan University of Medical Sciences, Isfahan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2719
Email address
azadbakht@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2012-05-01, 1391/02/12
Expected recruitment end date
2012-09-01, 1391/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of high protein diet on inflammatory markers and cvd risk factors in overweight and obese children
Public title
Effect of high protein on cvd risk factors and inflammation in obese children
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: if they had not known kidney, liver, cardiovascular, allergy, respiratory, thyroid diseases and diabetes; did not taken medications.
exclusion criteria: if they did not followed their prescribed diet; had hypercholesterolemia and hypertension.
Age
From 6 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Commitee Of Esfahan Univercity Of Medical Scie
Street address
Esfahan Univercity of Medical ScienceS
City
Esfahan
Postal code
Approval date
2012-01-03, 1390/10/13
Ethics committee reference number
190169
Health conditions studied
1
Description of health condition studied
overweight and obesity
ICD-10 code
e66.0
ICD-10 code description
ovweight and obesity in children
Primary outcomes
1
Description
Aiponectin
Timepoint
week 0 and 10
Method of measurement
biochemical tests
2
Description
hs-CRP
Timepoint
week 0 and 10
Method of measurement
biochemical tests
3
Description
tumor necrosis factor alpha
Timepoint
week 0 and 10
Method of measurement
biochemical tests
4
Description
interlukine 6
Timepoint
week 0 and 10
Method of measurement
biochemical tests
Secondary outcomes
1
Description
anthropometric measurements
Timepoint
week 0 and 10
Method of measurement
meter, scale
2
Description
LDL cholesterol
Timepoint
week 0 and 10
Method of measurement
biochemical tets
3
Description
HDL cholesterol
Timepoint
week 0 and 10
Method of measurement
biochemical tets
4
Description
total cholesterol
Timepoint
week 0 and 10
Method of measurement
biochemical tets
5
Description
triglyceride
Timepoint
week 0 and 10
Method of measurement
biochemical tets
6
Description
Fasting blood glucose
Timepoint
week 0 and 10
Method of measurement
biochemical tets
7
Description
blood pressure
Timepoint
week 0 and 10
Method of measurement
kaff
8
Description
fasting blood insulin
Timepoint
week 0 and 10
Method of measurement
biochemical tets
Intervention groups
1
Description
intervention: high protein diet
Category
Lifestyle
2
Description
control: standard protein diet
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
clinics of pediatrics
Full name of responsible person
Street address
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Leila Azadbakht
Street address
Hezar Jarib street, Azadi square, Esfahan University of Medical Sciences, School of Nutrition and Food Sciences
City
Esfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Vajihe Izadi
Position
MsC
Other areas of specialty/work
Street address
Esfahan University of Medical Sciences, School of Nutrition and Medical Sciences
City
Esfahan
Postal code
0009136964736
Phone
+98 913 696 4736
Fax
izadi.nutr84@ymail.com
Email
izadi.nutr84@ymail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Lleila Azadbakht
Position
Associate Professor
Other areas of specialty/work
Street address
Esfahan University of Medical Sciences, School of Nutrition and Food Sciences
City
Esfahan
Postal code
0003117922719
Phone
+98 31 1792 2719
Fax
azadbakht@hlth.mui.ac.ir
Email
azadbakht@hlth.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Leila Azadbakht
Position
associate proffesser
Other areas of specialty/work
Street address
Esfahan University of Medical Sciences, School of Nutrition and Food Sciences
City
Postal code
0003117922719
Phone
+98 31 1792 2719
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)