Protocol summary

Summary
The present study will try to examine the effect of skim milk compared to full-fat milk and apple juice on satiety and short-term energy intake. 50 obese children aged 10 to 12 years (25 girls and 25 boy) will be enrolled based on inclusion and exclusion criteria. All the participants will randomly consume the three test beverages (skim milk, whole milk and apple juice) in three intervention periods. Each intervention period will last for two consecutive days. In all intervention days participants will be asked to come to school in a fasted state. They will consume 240 ml of the test beverages with breakfast (energy and the composition of breakfast will be the same for all intervention periods). furthermore, one serving of fruit (similar in 3 intervention periods) will be given to the children as a snack during all intervention days. Intervention periods will be 5 days apart. Visual analog scale (VAS) test for appetite will be filled by participants before and after breakfast, before each snack and lunch to assess the participants' appetite throughout intervention days. furthermore a weighted ad libitum lunch will be provided for all participants to assess the energy intake after each intervention and then the remaining food will be weighted to assess the food intake of children at lunch . The appetite and energy intake of children at lunch on the intervention periods will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016072012571N5
Registration date: 2016-10-09, 1395/07/18
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-10-09, 1395/07/18
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
Recruitment complete
Funding source
Vice Chancellor for Research, Shahid Sadoughi University of Medical Sciences, yazd, Iran
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of skim milk compared to whole milk and apple juice intake at breakfast on appetite and short-term energy intake in obese children
Public title
The effect of skim milk compared to whole milk and apple juice on appetite and energy intake
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Children aged 10-12 years; Children who are defined as obese based on world health organization (WHO) criteria [having a body mass index (BMI) above the 95th percentile based on BMI-for-age charts defined by WHO]; Children and their parents who have intention to be entered to the study; Children who are not on a special diet at the time of the study or do not intend to go on a diet during the study period; Children whose parents do not report any history of cow milk intolerance; Children whose parents do not report any history of congenital or metabolic diseases; Regular breakfast consumption based on information provided by parents. Exclusion criteria: Refusing to participate in at least two intervention periods; Desire to withdraw from the study for any reason.
Age
From 10 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
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
Ethics committe of Shahid Sadoughi University of Medical Sciences
Street address
Chancellery for research, Central Building of Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd, Iran
City
Yazd
Postal code
​8915173160
Approval date
2016-11-27, 1395/09/07
Ethics committee reference number
IR.SSU.SPH.REC.1394.104

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
Appetite
Timepoint
Before breakfast, after breakfast and 3 times every hour until lunch and Just before lunch
Method of measurement
Visual Analogue Scale (VAS) for appetite

2

Description
Short-term Energy intake
Timepoint
One time at lunch meal
Method of measurement
Analysis of food intake at lunch

Secondary outcomes

1

Description
Weight
Timepoint
Four times: at baseline and before the start of each period of intervention
Method of measurement
measurement Using a digital scale with minimal wear

Intervention groups

1

Description
intervention:Including 240 ml skim milk in breakfast
Category
Other

2

Description
intervention: Including 240 ml apple juice in breakfast
Category
Other

3

Description
intervention: Including 240 ml high fat milk in breakfast
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Two elementary schools in Isfahan (one for girls and one for boys)
Full name of responsible person
Shima Kavezade
Street address
Department of Nutrition, Faculty of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, shahid sadughi yazd University of Medical Sciences
Full name of responsible person
Dr. Amirhushang Mehrparvar
Street address
Chancellery for research, Central Building of Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd, Iran
City
Yazd
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, shahid sadughi yazd 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
Nutrition and Food Security Research Center
Full name of responsible person
Dr. Azadeh Najarzadeh
Street address
Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nutrition and 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
Nutrition and Food Security Research Center, Shahid Sadughi University of medical Sciences, Yazd, Ir
Full name of responsible person
Shima Kavezade
Position
MSc student of Health Sciences in Nutrition
Other areas of specialty/work
Street address
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran.
City
Yazd
Postal code
Phone
+98 35 3820 9100
Fax
Email
sh.kavezade@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, I
Full name of responsible person
Amin Salehi-Abargouei
Position
PhD in Nutrition Sciences
Other areas of specialty/work
Street address
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran.
City
yazd
Postal code
Phone
+98 35 3820 9100
Fax
Email
abargouei@ssu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nutrition and Food Security Research Center, Shahid Sadughi University of medical Sciences, Yazd, Ir
Full name of responsible person
Shima Kavezade
Position
MSc student of Health Sciences in Nutrition
Other areas of specialty/work
Street address
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran.
City
Yazd
Postal code
Phone
+98 358209100
Fax
Email
sh.kavezade@yahoo.com
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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