Determining the effect of green tea and wheat bran on the diagnostic indicators of Metabolic Syndrome on Shahroud drivers in 2020
Design
A clinical trial with two intervention groups and one control group, with permuted blocks randomization, without blinding
Settings and conduct
After obtaining the Ethic Code and Registration at the Iranian Clinical Trial Center, investigating the drivers with health record in Kasra occupational clinic will be started. Then 90 patients with metabolic syndrome based on ATP (Adult Treatment Panel) definition will include to the study. After that, they will divide into the 2 intervention groups and 1 control group by permuted blocks randomization. Before the interventions, parametric and laboratory variables will assessed and then after 2 months will reassess.
Participants/Inclusion and exclusion criteria
Inclusion criteria: consent for study participation, existence of driver's health record, metabolic syndrome based on ATP (Adult Treatment Panel) definition, age range 40-50 years
Exclusion criteria: history of a gastrointestinal disease and/or a liver disease, treatment with corticosteroid medications (causes overweight due to peripheral edema).
Intervention groups
Participants will be divided into 3 groups (green tea, bran and control) with 30 individuals for each group for 2 months. The green tea group will consume 3 cups of green tea bag (one gram) daily without added sugar or milk and the bran group will consume 3.5 gram wheat bran powder daily in combination with yogurt or rice. Products with sanitary packaging and standard logos will be offered to intervention groups. The control group will consume 3 cups of water daily.
Main outcome variables
Laboratory tests (High Density Lipoprotein, Fasting Blood Sugar,Triglyceride), measuring blood pressure and waist circumference.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200217046524N1
Registration date:2020-05-25, 1399/03/05
Registration timing:retrospective
Last update:2020-05-25, 1399/03/05
Update count:0
Registration date
2020-05-25, 1399/03/05
Registrant information
Name
Mina Shayestefar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 0193
Email address
m.shayestefar@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-04-19, 1399/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of green tea and wheat bran on diagnostic indicators of metabolic syndrome in Shahroud drivers in 2020
Public title
Assessment the effect of green tea and wheat bran on metabolic syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study
Existence driver's health record
Metabolic syndrome based on ATP definition
Age range 40 to 50 years
Exclusion criteria:
A history of gastrointestinal disease
A history of liver disease
Being treated with corticosteroid drugs
Age
From 40 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be done using six Permuted Block Randomization methods. The total number of participants in this study is 90, which will be included in 3 groups of 30 people (2 intervention groups and one control group). 10 blocks of 6 will be determined and we will give each block from one to 10 numbers. Then, using the table of random numbers, 15 one-digit numbers (between 0 and 9) are selected completely randomly, and based on each of the selected numbers, a block is determined from the ten blocks (each of the randomly numbers will be corresponding to the same block number except for the number zero which corresponds to the tenth block). Eligible individuals are assigned to three groups based on the arrangement of each block from left to right.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Avenue
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2020-02-04, 1398/11/15
Ethics committee reference number
IR.SEMUMS.REC.1398.274
Health conditions studied
1
Description of health condition studied
Metabolic Syndrome
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome
Primary outcomes
1
Description
Height
Timepoint
The measurement will be performed at baseline and before the intervention.
Method of measurement
By the meter
2
Description
Weight
Timepoint
Measurements will be taken at the beginning of the study before the intervention and will be repeated after 2 months and at the end of the intervention.
Method of measurement
By a balance scales
3
Description
Systolic & Diastolic pressure
Timepoint
Measurements will be taken at the beginning of the study before the intervention and will be repeated after 2 months and at the end of the intervention.
Method of measurement
By a Sphygmomanometer
4
Description
Abdominal circumference
Timepoint
Measurements will be taken at the beginning of the study before the intervention and will be repeated after 2 months and at the end of the intervention.
Method of measurement
By a meter
5
Description
Fasting Blood Sugar
Timepoint
Measurements will be taken at the beginning of the study before the intervention and will be repeated after 2 months and at the end of the intervention.
Method of measurement
By a Micro-plate Eliza Reader with Parsazmun kits
6
Description
Triglycerides
Timepoint
Measurements will be taken at the beginning of the study before the intervention and will be repeated after 2 months and at the end of the intervention.
Method of measurement
By a Micro-plate Eliza Reader with Parsazmun kits
7
Description
High Density Lipoprotein
Timepoint
Measurements will be taken at the beginning of the study before the intervention and will be repeated after 2 months and at the end of the intervention.
Method of measurement
By a Micro-plate Eliza Reader with Parsazmun kits
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Green Tea- To the Green Tea Group will be recommended 3 cups of simple green teabag (one gram) daily from without added sugar or milk for 2 months. There will be provided from hygienic packaging products from Golestan brand with standard logo.
Category
Treatment - Other
2
Description
Second intervention group: Wheat bran- To the wheat bran group will be recommended 3.5 gram wheat bran powder based on individual taste with yogurt or rice daily for 2 months. There will be provided from hygienic packaging products of Nan Avaran brand with standard logo.
Category
Treatment - Other
3
Description
Control group: For the control group, 3 cups of water per day more than last daily consumption will be recommended.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kasra occupational medicine center
Full name of responsible person
Mina Shayestefar
Street address
No 2, first floor, first block, Pasargad building, Negarestan street, Baghzendan Ave
City
Shahroud
Province
Semnan
Postal code
3616787873
Phone
+98 23 3224 0934
Fax
+98 23 3224 0934
Email
m.shayestefar@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1022
Email
parviz.kokhaei@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mina Shayestefar
Position
Instructor, faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1022
Email
m.shayestefar@semums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mina Shayestefar
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Taavon street- first west 16 th- Fotros- 2th unit
City
Semnan
Province
Semnan
Postal code
3514774913
Phone
+98 23 3345 0193
Fax
Email
m.shayestefar@semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mina Shayestefar
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Taavon street- first west 16 th- Fotros- 2th unit
City
Semnan
Province
Semnan
Postal code
3514774913
Phone
+98 23 3345 0193
Fax
Email
m.shayestefar@semums.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
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
All data, protocols and forms of conscious consent can be shared (after individuals have been unrecognizable), .
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
It will only be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
No analysis should be performed on the data.
From where data/document is obtainable
Email: m.shayestefar@semums.ac.ir
Mina Shayestehfar - Faculty Member of Semnan University of Medical Sciences
What processes are involved for a request to access data/document
After reviewing the application and 6 months have passed since the results were published, the data will be sent within a week if the application of results are confirmed for the applicant.