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Evaluation effect of daily consumption of whey protein on anthropometric indices , body composition and blood pressure in overweight or obese children

Protocol summary

Study aim
Determining the effect of whey protein on body composition and anthropometric indices and blood pressure in overweight and obese children.
Design
Clinical trials, with parallel groups, one-on-one blind, Block permutation randomized
Settings and conduct
After that the population studied was identified. Demographic data including age and sex, anthropometric information including height and weight, waist circumference and blood pressure, and body composition analysis, before, during and after intervention, will be performed for each interested person. They will also be asked to record their physical activity and diet for 2 days. and each group participates in the study for 8 weeks with iso-calorie diet The participants, the outcome assessor and the data analyst, are unaware of the fact that the individuals received the packages of the intervention or received the placebo. The intervention group and placebo packages have the same size and appearance.
Participants/Inclusion and exclusion criteria
Body mass index percentile higher than 85 Blood pressure less than 160/100 Not suffering from any liver, digestive, kidney, kidney stones, diabetes, thyroid disease Not having allergy to milk and its products Not taking medications that affect body weight
Intervention groups
Individuals are divided into 2 groups according to the randomized block permutation method, and each group participates in the study for 8 weeks with iso-calorie diet. The intervention group consumes a 20 grams whey protein drink once a day, half an hour before eating lunch. The control group also takes 20 grams of maltodextrine once a day, half an hour before lunch.
Main outcome variables
height and weight, waist circumference and blood pressure, and body composition

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180825040861N1
Registration date: 2018-10-09, 1397/07/17
Registration timing: registered_while_recruiting

Last update: 2018-10-09, 1397/07/17
Update count: 0
Registration date
2018-10-09, 1397/07/17
Registrant information
Name
Seyede Zahra Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3820 6774
Email address
hashemizahra70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-11, 1397/06/20
Expected recruitment end date
2018-10-17, 1397/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation effect of daily consumption of whey protein on anthropometric indices , body composition and blood pressure in overweight or obese children
Public title
Evaluation effect of daily consumption of whey protein on anthropometric indices , body composition and blood pressure in overweight or obese children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index percentile higher than 85 Blood pressure less than 160/100 being 7-13 years old
Exclusion criteria:
Suffering from any liver, digestive, kidney, kidney stones, diabetes, thyroid disease Having allergy to milk and its products Taking medications that affect body weight
Age
From 7 years old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Block permutation The random assignment method is performed in such a way that it is written in 50 pieces of paper (25 c code and 25 t code) and randomly drawn out of one of the paper in the order that the individuals refer to. It is determined which group to be assigned to.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants, the outcome assessor and the data analyst, are unaware of the fact that the individuals received the packages of the intervention or received the placebo. The intervention group and placebo packages have the same size and appearance.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
•Ethics committee of Shiraz University of Medical Sciences
Street address
zand street, shiraz University of Medical Sciences
City
shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Approval date
2017-07-23, 1396/05/01
Ethics committee reference number
IR.SUMS.REC.1396.39

Health conditions studied

1

Description of health condition studied
over weight and obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
weight
Timepoint
1،14، 28، 56 th day
Method of measurement
Scales

Secondary outcomes

empty

Intervention groups

1

Description
"Intervention group:" The sachet (once every 2 weeks) will be given to the participants for 8 weeks. Each sachet in the intervention group consists of 20 g of proteins, steviosides and flavors, which should be Consumpted daily half an hour before Lunch up to 8 weeks .( Adding 1 sachet to a 60 ml of boiling water (one quarter of a glass))
Category
Treatment - Other

2

Description
"Control group:" The sachet (once every 2 weeks) will be given to the participants for 8 weeks. Each sachet in the control group consists of 20 g of maltodextrine, steviosides and flavors, which should be Consumpted daily half an hour before Lunch up to 8 weeks .( Adding 1 sachet to a 60 ml of boiling water (one quarter of a glass))
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Mottahari hospital
Full name of responsible person
Dr Siavash Babajafari
Street address
Rzi bolvard
City
shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
scnutrition@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Seyed Basir Hashemi
Street address
Zand Street,
City
Shiraz
Province
Fars
Postal code
71645-111
Phone
+98 71 3725 1007
Email
scnutrition@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Seyede Zahra Hashemi
Position
Msc Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Razi s.t
City
Shiraz
Province
Fars
Postal code
71645-111
Phone
+98 71 3725 1005
Email
hashemizahra70@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Siavash Babajafari
Position
assistant professor of nutrition
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
razi bolvard
City
Shiraz
Province
Fars
Postal code
7176673797
Phone
+98 71 3725 1005
Email
hashemizahra70@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyedeh Zahra Hashemi
Position
Msc student in Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
razi bolvard
City
Shiraz
Province
Fars
Postal code
7176673797
Phone
+98 71 3725 1005
Email
hashemizahra70@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Consent form of participation in the project
When the data will become available and for how long
97/6/10
To whom data/document is available
Related parties
Under which criteria data/document could be used
For more information
From where data/document is obtainable
Shiraz university of medical sciences
What processes are involved for a request to access data/document
call or in-person
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