Protocol summary

Summary
The objective is to study the effects of low glycemic index diet on inflammatory factors, adiponectin, lipid profile and apolipoproteins in obese and overweight girls. Obese or overweight girls who have catamenia and their ages are less than 18 years are included in this study. The subjects not following the research protocols will be excluded. The requirement sample size is 36 subjects. This parallel study will be conducted in 10 weeks. Low glycemic index diet is administered to intervention group and nutritional healthy guidelines are administered to non-intervention group. At the end of the study, anthropometric variables, blood pressure, inflammatory factors, adiponectin and lipid profile will be evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201109272839N4
Registration date: 2011-11-08, 1390/08/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-11-08, 1390/08/17
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
2011-09-01, 1390/06/10
Expected recruitment end date
2011-11-21, 1390/08/30
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
The effect of low glycemic index diet on childhood obesity
Public title
The effect of low glycemic diet on metabolic status and inflammation in obese girls
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: being girl; being in pubertal age; less than 18 years old; being in >85th percentile of WHO's body mass index; Not incidence of chronic or acute diseases; not consuming confounding medications exclusion criteria: low compliance to administrated diet; Incidence of chronic or acute diseases; Beginning to consume confounding medications; Not following the research protocol
Age
From 13 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
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 science
City
Esfahan
Postal code
Approval date
2011-10-01, 1390/07/09
Ethics committee reference number
390246

Health conditions studied

1

Description of health condition studied
overweight and obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
low glycemic indexdiet
Timepoint
in 2nd, 4th, 6th, 8th and 10th weeks
Method of measurement
dietary record

Secondary outcomes

1

Description
bmi,weight,height,waist circumference,SBP,DBP
Timepoint
At the begining of the study and 2th, 4th, 6th, 8th, 10th weeks
Method of measurement
barometer, digital scales, meter

2

Description
adiponectine, CRP, IL-6
Timepoint
baseline and at the end of the study
Method of measurement
biochemical test

3

Description
HDL, LDL, FBS, TG, TC
Timepoint
baseline and at the end of the study
Method of measurement
biochemical test

4

Description
Apo A, Apo B100, insulin, lip a
Timepoint
baseline and at the end of the study
Method of measurement
biochemical test

Intervention groups

1

Description
intervention group: low glycemic indx diet duration: 10weeks
Category
Lifestyle

2

Description
non-intervention group: healthy dietary guidelines duration: 10weeks
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan medical university
Full name of responsible person
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan medical university
Full name of responsible person
Leila Azadbakht
Street address
Isfahan medical university, Azadi square, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan medical university
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
Isfahan medical university
Full name of responsible person
Sayyed Mohammad Hossein Rouhani
Position
Msc student
Other areas of specialty/work
Street address
department of public nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences
City
Hsfahan
Postal code
Phone
+98 913 327 6157
Fax
Email
s_m_rouhani2003@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan medical university
Full name of responsible person
Leila Azadbakht
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2719
Fax
Email
azadbakht@hlth.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan Medical university
Full name of responsible person
Leila Azadbakht
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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