Effect of the effect of Nuts on the cognitive function in obese 8-10 year old girls in Kermanshah
Design
This study was conducted in a clinical trial with a blinded one-blind, parallel-group, 90 girl aged 10-8 years with obesity who will be randomly assigned to the control and intervention groups.
Settings and conduct
This study will be conducted during 16 weeks on 90 girl aged 10-8 year old with obesity in Kermanshah. After explaining the purpose of the study and obtaining informed, the subjects will be evaluated for anthropometric indices, nutritional status and cognitive function. To evaluate the cognitive function, a Wechsler questionnaire for children and a BRIEF questionnaire (Behavioral Compliance Questionnaire for executive functions) will be used. Subjects will then be classified into control and intervention groups in such a way that participants will not be aware of the allocation of the groups. The intervention group will receive 30 grams nuts per day, and the control group will not take the placebo.
Participants/Inclusion and exclusion criteria
The age group of 8-10 years, at least 3 years of obesity, lack of underlying conditions such as diabetes, endocrine diseases and diseases of the cardiovascular system and liver and lack of professional sports.
Intervention groups
The first group will receive 30 grams of nuts containing 15 grams of walnuts, 7.5 grams of almonds and 7.5 grams of hazelnuts (divided in 2 doses per day), and the second group did not receive any placebo treatment.
Main outcome variables
cognitive functions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181111041611N2
Registration date:2019-09-15, 1398/06/24
Registration timing:prospective
Last update:2019-09-15, 1398/06/24
Update count:0
Registration date
2019-09-15, 1398/06/24
Registrant information
Name
Mehnoosh Samadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3710 2009
Email address
mehnoosh_samadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-10-12, 1398/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Nuts on the cognitive function in obese 8-10 year old girls in Kermanshah
Public title
Impact of nuts on cognitive function
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least 3 years old with obesity
Exclusion criteria:
Not having underlying diseases such as diabetes, endocrine disease, cardiovascular and liver disease
Lack of professional exercise
Age
From 8 years old to 10 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: cluster
Referring to the education of Kermanshah, the city's schools list will be selected and 9 schools will be randomly selected. In each school, 5 people will be randomly assigned to the intervention group and 5 will be selected for the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Building No. 2, Research Council of Kermanshah University of Medical Sciences (KUMS), Shahid Beheshti Boulevard, Kermanshah, Iran.
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Approval date
2019-07-09, 1398/04/18
Ethics committee reference number
IR.KUMS.REC.1398.365
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Cognitive functions score in the Wechsler questionnaire and the BRIEF questionnaire (Behavioral Rating Schedule for Executable Functions).
Timepoint
Before the start of the study, 8 and 16 weeks after the start of the intervention
Method of measurement
Wechsler questionnaire and the BRIEF questionnaire (Behavioral Rating Schedule for Executable Functions).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention with 30 grams of nuts containing 15 grams of walnuts, 7.5 grams of almonds and 7.5 grams of hazelnuts (in two doses in the morning and evening) daily.
Category
Treatment - Other
2
Description
Control group: This group does not receive any intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Schools in Kermanshah
Full name of responsible person
Karam Ahmadian
Street address
Gomrek Street, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714897767
Phone
+98 83 3823 0218
Email
shimamoradi21@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Building No. 2, Research Council Kermanshah University of Medical Sciences (KUMS), Shahid Beheshti Boulevard, Kermanshah, Iran.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3837 6892
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mehnoosh Samadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences,Above Farabi Hospital,Iesar Square
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3710 2009
Email
mehnoosh_samadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reza amani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences, school of Nutrition and Food Science, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
6104337945
Phone
+98 31 3792 3175
Email
r_amani@mail.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fateme Sheikhi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Third Robat St,Shadi St,Pedrem Alley
City
Isfahan
Province
Isfehan
Postal code
8196743871
Phone
+98 31 3440 5545
Email
Sheikhi.fateme@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Trail that began to fall ill on 23th of September 2019 should have a release plan when recording its study protocol.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available