Protocol summary

Summary
The study aims to compare the effectiveness of high-calorie, high-fat diets with different glycemic index, on some indicators related to diabetes and oxidative stress in children and adolescents with cystic fibrosis..In this study, which is a double blind randomized controlled trial, study population are children and adolescents with cystic fibrosis who will come to cystic fibrosis clinic in Children Medical Center. After Cystic Fibrosis in patients was approved by pulmonogists, patients will be referred to nutrition team in order to get proper diet.After assessment for inclusion criteria, including the age range between 2-18 , children and adolescents with cystic fibrosis whose disease is approved by sweat test or genetic test by the clinician, willingness to cooperate and participate in the study and not having no entry criteria like:developing other chronic diseases, severe liver disease (cirrhosis), hospitalization at baseline or one month earlier in the hospital, undergoing surgery in the next three months or a month before the start of the study (with the exception of dental surgery).Benefits and risks will be explained to parents and children explanation will be given to parents and children if they were willing to cooperate the consent form will be signed by parent or children.In second visit 10 cc of blood for biochemical tests will be taken from patients, general information and individual characteristics forms as well as dietary recall questionnaire will be filled. Indicators related to anthropometric characteristics before the intervention, including height (height gauge with accuracy of 0.5 cm), weight (by scales Seca carefully 100g) will be measured and BMI (Body Mass Index)will be calculated by formula and will be recorded in general informatin form.Selection of one of the two regimes was through randomization method by Stratified Randomized Block Design in terms of sex and age and patients will be entered into one the two groups high calorie, high fat or high calorie, high fat diet with low glycemic index( sample size of each group=21). The number of food units per serving which is written in paper, and Exchange List tab and nutritional advice and allowed foods(for Group II) will be given to each of the patients in both group. Patients will be assessed via telephone whether they adhere to their diets every two weeks within three months. The researcher will be available to answer any questions and fix problems with the regime through this time.In last visit after three months from the begining of the intervention 10 cc of blood for biochemical assessment will be taken and height and weight and BMI of the patients after three months of intervention will be recorded in general information form.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015112825267N1
Registration date: 2017-05-21, 1396/02/31
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-05-21, 1396/02/31
Registrant information
Name
Maryam Mahmoudi
Name of organization / entity
School of Nutritional Sciences & Dietetics, Tehran University of Medical Sciences,
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5975
Email address
m-mahmoudi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-09-15, 1395/06/25
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison Between High Calorie,High Fat Diets with Different Glycemic Indexes on Some Biomarkers Related to Diabetes and Oxidative Stress in Children and Adolecents with Cystic Fibrosis
Public title
Comparison Between Two Different Diets in Children and Adolecents with Cystic Fibrosis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: children and adolescents aged 2-18; children and adolescents who affected disease is confirmed by genetic or sweat test; willingness to cooperate Exclusion criteria: unwilling to cooperate and continue; inability to pursue each types of the diet; urgent need of hospitalization during trial; urgent need of operation during trial
Age
From 2 years old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods Street, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2017-07-25, 1396/05/03
Ethics committee reference number
IR.TUMS.VCR.REC.1395.489

Health conditions studied

1

Description of health condition studied
cystic fibrosis
ICD-10 code
E84
ICD-10 code description
cystic fibrosis

Primary outcomes

1

Description
insulin
Timepoint
pre intervention and 3 months after begining the diet
Method of measurement
ELISA Kit

2

Description
fasting blood glucose
Timepoint
pre intervention and 3 months after begining the diet
Method of measurement
ELISA Kit

3

Description
HDL cholostrol
Timepoint
pre intervention and 3 months after begining the diet
Method of measurement
measurement of variables blood level biochemically

4

Description
LDL cholestrol
Timepoint
pre intervention and 3 months after begining the diet
Method of measurement
biochemical measurement

5

Description
MDA
Timepoint
pre intervention and 3 months after begining the diet
Method of measurement
ELISA Kit

6

Description
RBP4
Timepoint
pre intervention and 3 months after begining the diet
Method of measurement
ELISA Kit

7

Description
HbA1c
Timepoint
pre intervention and 3 months after begining the diet
Method of measurement
ELISA Kit

8

Description
Total cholestrol
Timepoint
pre intervention and 3 months after begining the diet
Method of measurement
biochemical measurement

Secondary outcomes

1

Description
Height
Timepoint
begining of the trial and three months after
Method of measurement
meter

2

Description
weight
Timepoint
begining of the trial and three months after
Method of measurement
Scale

Intervention groups

1

Description
Intervention group: Following High fat , High calorie diet with low gycemic index for three months
Category
Prevention

2

Description
control: Following high fat , high calorie diet for three months
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Children Medical Center Hospital
Full name of responsible person
Niloufar Arabzadegan
Street address
No 24, Rahmati-Behambari Alley, Valiasr Street, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical sciences
Full name of responsible person
Mrs. Khoshtarkib
Street address
Tehran University of Medical Sciences , Ghods Street , Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Niloufar Arabzadegan
Position
Master Student in Nutritional Sciences
Other areas of specialty/work
Street address
School of Nutritional Sciences And Dietetics, Hojjat Doost Alley, Naderi Street , Keshavarz Blvd, Tehran
City
Tehran
Postal code
Phone
+98 913 745 1805
Fax
Email
niloufar.arabzadegan@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
Maryam Mahmoudi
Position
Associate Professor /PhD in nutritional sciences
Other areas of specialty/work
Street address
School of Nutritional Sciences And Dietetics, Hojjat Doost Alley, Naderi Street, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 8895 5698
Fax
Email
m-mahmoudi @sina.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
Niloufar Arabzadegan
Position
Master Student in Nutritional Sciences
Other areas of specialty/work
Street address
School Of Nutritional Sciences And Dietetics, Hojjat Doost Alley, Naderi Street, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 913 745 1805
Fax
Email
Web page address

Sharing plan

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