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Effect of Observing Nutrition Principles of Traditional Iranian Medicine in Eating on some Blood Biochemical Factors in Blood Serum of Students Residing in Dormitories

Protocol summary

Study aim
Effect of Observing Nutrition Principles of Traditional Iranian Medicine in Eating on some Blood Biochemical Factors in Blood Serum of Students Residing in Dormitories of Kerman University of Medical Sciences
Design
Two arm parallel group randomized trial not blind branch randomization
Settings and conduct
Firstly, they will be measured by the EQS and then properly educated and educated on the basis of traditional medicine by a resident of traditional medicine for one day for students. Students will be reminded by telephone every day of the week, and follow up on traditional medicine recommendations. After 91 days, the questionnaire will be re-evaluated. The principles of eating and drinking will be reassessed. Those who follow these principles and the score of their questionnaire have the highest increases will be selected. . Blood samples will then be taken from these individuals to measure the biochemical parameters of the blood. At the same time, the control group is sampled in the same conditions at two times, but without the training.
Participants/Inclusion and exclusion criteria
The criteria for entering the study include: 1- A student living in a dormitory who uses only university food. 2- Declaration of consent to participate in the investigation and signature of the informed consent form 3. Lack of any disease: including diabetes, hypertension, cardiovascular disease but not limited to these cases. 4. Not taking any medication 5. Abuse of substances and alcohol.
Intervention groups
The education of proper eating and drinking principles is given to the group and its compliance with the questionnaire is evaluated. In the control group the education is not given but, the level of observance of these principles is assessed by the questionnaire.
Main outcome variables
Biochemical Factors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190101042200N1
Registration date: 2019-12-22, 1398/10/01
Registration timing: retrospective

Last update: 2019-12-22, 1398/10/01
Update count: 0
Registration date
2019-12-22, 1398/10/01
Registrant information
Name
Alireza Zahedi Neyestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 9029
Email address
alzatani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-29, 1398/05/07
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Observing Nutrition Principles of Traditional Iranian Medicine in Eating on some Blood Biochemical Factors in Blood Serum of Students Residing in Dormitories
Public title
Effect of Observing Nutrition Principles of Traditional Iranian Medicine in Eating on some Blood Biochemical Factors
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Students living in a dormitory who uses only university food Declaration of consent to participate in the investigation and signature of the informed consent form Not having any disease: including diabetes, hypertension, cardiovascular disease, but not limited to these cases.
Exclusion criteria:
Unwillingness and satisfaction to continue cooperation The incidence of any acute illness that results in the use of any drug during the study. (Including, but not limited to, analgesics, steroidal and non-steroidal anti-inflammatory drugs, gastrointestinal drugs, anti-acid drugs, cholinergics, anticholinergics) Drug abuse and Alcohol
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
More than 1 sample in each individual
Number of samples in each individual: 1
5 cc venous blood
Randomization (investigator's opinion)
Randomized
Randomization description
As students who live in the same room or flat may transfer the information to each other, we will randomized dormitories into intervention and control groups.In each dormitory, stratified sampling (according to level of current education) will be used to recruit sample.
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 Committe of Kerman University of Medical Sciences
Street address
ٍEbne sina street
City
Kerman
Province
Kerman
Postal code
2263857226
Approval date
2019-07-23, 1398/05/01
Ethics committee reference number
IR.KMU.REC.1397.356

Health conditions studied

1

Description of health condition studied
Life style in apparently healthy people
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Fasting blood sugar
Timepoint
Before and 12 weeks after intervention
Method of measurement
Examine the patient's blood sample in the laboratory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Dormitory students eating self-service meals
Category
Lifestyle

2

Description
Control group: Dormitory students who receive self-service meals have received the instruction of proper eating and drinking principles in Iranian Traditional Medicine
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Student Residences of Kerman University of Medical Sciences
Full name of responsible person
Alireza Zahedi Neyestani
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
ali.zahedi@kmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Kerman University of Medical Sciences
Full name of responsible person
Pardakhti Abbas
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5856
Fax
+98 34 3132 5856
Email
ali.zahedi@kmu.ac.ir
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 of Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Alireza Zahedi Neyestani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5856
Email
ali.zahedi@kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Alireza Zahedi Neyestani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5856
Fax
+98 34 3132 5856
Email
ali.zahedi@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Alireza Zahedi Neyestani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5856
Fax
+98 34 3132 5856
Email
ali.zahedi@kmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The research will be published as a paper upon completion.
When the data will become available and for how long
Three months after the article was published
To whom data/document is available
All researchers
Under which criteria data/document could be used
There are no restrictions
From where data/document is obtainable
Corresponding author. Alireza Zahedi Neyestani alzatani@gmail.com 00989159406840 .00983442110860
What processes are involved for a request to access data/document
Upon receipt of the request by fax or email, the request will be reviewed and, if it is not in accordance with the pre-established criteria,the response or requested documentation will be sent.
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