Current study will be a randomized cross-over clinical trial. 20 children aged 10 to 12 y will be enrolled based on the inclusion criteria. They will randomly be divided into three inevention groups (breakfast with low-fat milk, Juice or water). Each intervention period will last 2 consecutive days. A group of Children will consume a breakfast including 240 mL low-fat milk, children in the second group will recieve 240 mL apple juice and children in third group will receive same volume of water (Energy for the first and second group and the composition of breakfast for all groups will be the same). One serving of fruit (similar in 3 groups) will be given to children as a snack during all intervention days. Intervention periods will be one week apart as a wash-out period. Visual analog scale (VAS) test for satiety will be used before each snack and lunch to assess the participant’s appetite before receiving each meal or snack, throughout intervention days. An ad libitum lunch will be provided for all participants to assess differences in energy intake after each intervention. Appetite and energy intake of children from snacks, lunch and rest of the day will be compared between 3 beverages.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013022312571N1
Registration date:2013-12-02, 1392/09/11
Registration timing:na
Last update:
Update count:0
Registration date
2013-12-02, 1392/09/11
Registrant information
Name
Amin Salehi-Abargouei
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 9100
Email address
abargouei@hlth.mui.ac.ir
Recruitment status
Not enough for processing
Funding source
1. Vice Chancellor for Research, Isfahan University of Medical Sciences, Isfahan, Iran.
2. Food security research center, Isfahan University of Medical Sciences, Isfahan, Iran.
Expected recruitment start date
2013-11-05, 1392/08/14
Expected recruitment end date
2013-01-18, 1391/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of milk consumption in breakfast on satiety and energy intake in 10-12 years old obese children
Public title
The effect of dairy consumption on energy intake and appetite
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: being obese based on WHO criteria (having a BMI above the 95th percentile based on BMI-for-age charts); not on a special diet and do not intend to go on diet during the study; children and their parents intend to be entered in the study; not having any cow milk intolerance; not having any history of congenital or metabolic diseases based on information provided by parents and consuming breakfast regularly.
Exclusion criteria: low cooperation (Refusing to participate in at least two of the interventions; Desire to withdraw from the study for any reason)
Age
From 10 years old to 12 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan Regional Bioethics Committee
Street address
Isfahan University of Medical Sciences, Hezarjarib St., Isfahan
City
Isfahan
Postal code
81745319
Approval date
2013-02-13, 1391/11/25
Ethics committee reference number
392165
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
energy intake
Timepoint
one time at lunch meal
Method of measurement
Analysis of food intake at lunch
2
Description
appetite
Timepoint
Five times per hour after intervention
Method of measurement
Visual analog scale for satiety
Secondary outcomes
1
Description
weight
Timepoint
Four times: at baseline and before the start of each period of intervention
Method of measurement
Using a digital scale with minimal wear
Intervention groups
1
Description
intervention:Including 240 ml low-fat milk in breakfast
Category
Other
2
Description
control: Including 240 ml apple juice in breakfast
Category
Other
3
Description
control: Including 240 ml water in breakfast
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
One of the elementary schools in the 4th educational district of Isfahan
Full name of responsible person
Sanaz Mehrabani
Street address
Isfahan, Asgarie street, next to the Arash park, hasane jafarian school
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
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
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
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
2
Sponsor
Name of organization / entity
Food security research center
Full name of responsible person
Dr Leila Azadbakht
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Food security research center
Proportion provided by this source
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, School of Nutrition and Food Science
Full name of responsible person
Sanaz Mehrabani
Position
MSc student of Nutrition
Other areas of specialty/work
Street address
Hezar Jarib Ave., Isfahan University of Medical Sciences,School of Nutrition and Food Science
City
Isfahan
Postal code
Phone
+98 31 1435 9511
Fax
Email
sanaz_mehr6500@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
Amin Salehi-Abargouei
Position
PhD candidate in nutrition
Other areas of specialty/work
Street address
Hezar Jarib Ave., Isfahan University of Medical Sciences, Hezarjarib St., Department of Nutrition and Food Science
City
Isfahan
Postal code
Phone
00
Fax
Email
abargouei@hlth.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Sanaz.Mehrabani
Position
MSc student of Nutrition
Other areas of specialty/work
Street address
Hezar Jarib Ave., Isfahan University of Medical Sciences, School of Nutrition and food sciences
City
Isfahan
Postal code
Phone
+93 114359511
Fax
Email
sanaz_mehr6500@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)