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Effect of citrus aurantium and citrus aurantifolia on endothelial function among overweight children and adolescents aged 9-18

Protocol summary

Summary
In this triple-blind clinical trial, 90 overweight or obese children and adolescents aged 9-18 years are randomly selected. Written informed consent will be obtained from parents. Inclusion criteria include age (9-18 years), and body mass index (BMI) above 85th centile for age and sex. Hypothyroidism, medical therapy for dyslipidemia, smoking or exposure to tobacco are considered as exclusion criteria. Demographic and anthropometric characteristics including age, sex, weight, height and BMI will be recorded. Lipid profile and flow-mediated dilation (FMD) showing endothelial dysfunction will be measured at baseline and end of the study. Participants will randomly assigned to three groups (each group includes 30 subjects), receiving citrus aurantium or citrus aurantifolia extracts or placebo (corn starch) capsules (1 capsule/12 hour), respectively. The study will last for one month. Statistical analysis will be conducted using SPSS version 20, Paired t-test, Analysis of Variance (ANOVA), and Post-hoc analysis will be used to test significant differences between study groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013102715190N1
Registration date: 2013-12-07, 1392/09/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-12-07, 1392/09/16
Registrant information
Name
Elham Khosravi Bakhtiari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1433 4332
Email address
elham_khosravi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2013-11-17, 1392/08/26
Expected recruitment end date
2014-02-19, 1392/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Effect of citrus aurantium and citrus aurantifolia on endothelial function among overweight children and adolescents aged 9-18
Public title
Effect of citrus aurantium and citrus aurantifolia on endothelial function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age (9-18 years); body mass index (BMI) above 85th centile for age and sex; no hypothyroidism. Exclusion criteria: medical therapy for dyslipidemia; smoking or exposure to tobacco.
Age
From 9 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this triple-masked study, participant, the project manager and statistician are not aware of randomly allocation of subjects to intervention and control groups.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib St.
City
Isfahan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
392115

Health conditions studied

1

Description of health condition studied
overweight and obesity
ICD-10 code
E65-E68
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
flow-mediated dilation (FMD)
Timepoint
baseline and at the end of the study (after 1 month intervention)
Method of measurement
high-resolution B-mode sonography

Secondary outcomes

empty

Intervention groups

1

Description
placebo (corn starch) as similar appearance capsules (1 capsule/12 hour) for control group
Category
Treatment - Drugs

2

Description
citrus aurantium capsules (1 capsule/12 hour) for intervention group 1
Category
Treatment - Drugs

3

Description
citrus aurantifolia capsules (1 capsule/12 hour) for intervention group 2
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Child Growth and Development Research Center
Full name of responsible person
Elham Khosravi
Street address
No 26, Ghaem blind-alley, Asiyab alley, Kaveh St.
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr.Peyman Adibi
Street address
Hezar jarib St. Vice chancellor for research, Isfahan University of Medical Sciences
City
Isfahan
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, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Elham Khosravi
Position
Resident of cardiovascular diseases
Other areas of specialty/work
Street address
Noor Hospital, Isfahan University of Medical Sciences
City
Isfahan
Postal code
00983112222127
Phone
+98 31 1222 2127
Fax
Email
ELHAMKHOSRAVI 1389@YAHOO.COM
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Mohammad Hashemi
Position
Specialist in cardiovascular diseases
Other areas of specialty/work
Street address
Noor Hospital, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1222 2127
Fax
Email
HASHEMI1344@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Elham Khosravi
Position
Resident of cardiovascular diseases
Other areas of specialty/work
Street address
Noor Hospital, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1222 2127
Fax
Email
ELHAMKHOSRAVI 1389@YAHOO.COM
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
empty
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