The comparison between high calorie, high fat diets with different glycemic indexes effect on some biomarkers related to diabetes and inflammatory factors and cytokines in children and adolecents with cystic fibrosis.
The aim of the present study is to compare the effectiveness of high-calorie, high-fat diets with different glycemic index, on some indicators related to diabetes and inflammatory factors and cytokines in children and adolescents with cystic fibrosis. This study is a randomized controlled trial. Populations are children and adolescents with cystic fibrosis who will come to cystic fibrosis clinic in Children Medical Center. After that cystic fibrosis in patients was approved by pulmonogists, patients will be referred to nutrition team in order to get proper diet. 42 Subjects will be randomly divided into two groups. For each patient anthropometric measurement and general characteristics will be assessed and 10 cc fasting blood sample will be taken at the baseline and end of the study. 24-h food record questionnaires will be completed every four week. Inclusion criteria include children and adolescents aged 2-18; children and adolescents who affected disease is confirmed by genetic or sweat test; willingness to cooperate the study. Exclusion criteria includes unwilling to cooperate and continue the study; inability to pursue each types of the diet; urgent need of hospitalization during trial; urgent need of operation during trial. Subjects will randomly receive either type of diets for 12 weeks. In last visit after three months from the beginning of the intervention, 10 cc of blood for biochemical assessment will be taken and height, 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:IRCT2017102325267N5
Registration date:2017-11-13, 1396/08/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-11-13, 1396/08/22
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
Vice chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-06-22, 1397/04/01
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 effect on some biomarkers related to diabetes and inflammatory factors and cytokines in children and adolecents with cystic fibrosis.
Public title
Comparison between two different diets in children and adolescents 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 19 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
Ethical Committee of Tehran University of Medical Sciences
Street address
Central building of Tehran University of Medical Sciences, conjunction of Keshavarz Blvd and Qods Street, Tehran, Iran
City
Tehran
Postal code
Approval date
2017-08-14, 1396/05/23
Ethics committee reference number
IR.TUMS.VCR.REC.1396.3171
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
fasting blood glucose
Timepoint
pre intervention and 3 months after begining the diet
Method of measurement
ELISA Kit
2
Description
HDL cholostrol
Timepoint
pre intervention and 3 months after begining the diet
Method of measurement
measurement of variables blood level biochemically
3
Description
LDL cholestrol
Timepoint
pre intervention and 3 months after begining the diet
Method of measurement
measurement of variables blood level biochemically
4
Description
Total cholestrol
Timepoint
pre intervention and 3 months after begining the diet
Method of measurement
measurement of variables blood level biochemically
5
Description
HbA1c
Timepoint
pre intervention and 3 months after begining the diet
Method of measurement
ELISA Kit
6
Description
INF gamma
Timepoint
pre intervention and 3 months after begining the diet
Method of measurement
ELISA Kit
7
Description
IL17-A
Timepoint
pre intervention and 3 months after begining the diet
Method of measurement
ELISA Kit
8
Description
IL-10
Timepoint
pre intervention and 3 months after begining the diet
Method of measurement
ELISA Kit
9
Description
IL-6
Timepoint
pre intervention and 3 months after begining the diet
Method of measurement
ELISA Kit
Secondary outcomes
1
Description
Height
Timepoint
begining of the trial and three months
Method of measurement
meter
2
Description
weight
Timepoint
begining of the trial and three months
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 group: following high fat, high calorie diet, with gycemic index higher than 55 for three months