Protocol summary

Summary
General Goal: Determination of A Period of Weight Training and Green Tea Supplement Effect on Cardiovascular Risk Factors Among Over weight and Obese Men Research Design: Randomized Inclusion criteria: men who have Body Mass Index(BMI) between 25 to 35 kg/m2; age between 27 to 42; lack of weight loss reduction; lack of any operation in spinal cord; lack of chronic backache; lack of deformity; non-smoker; lack of asthma history; lack of special disease and fracture Exclusion criteria: refusal from taking part in the research Sample size: 60 peoples Intervention case: Resistance exercise and Green Tea Supplement primary outcome: LDL, HDL, Tam Cholesterol, Triglyceride, Glucose, Insulin, Insulin Resistance, Body Mass Index (BMI), Waist to Hip Ratio (WHR), Body Fat Percentage

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015122423216N2
Registration date: 2016-02-11, 1394/11/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-02-11, 1394/11/22
Registrant information
Name
Said Amini Rarani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3522 6158
Email address
ghadami@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effect of a Period of Weight Training and Green Tea Supplement with Control Group on Cardiovascular Risk Factors among Over weight and Obese Men
Public title
The Effect of Weight Training and Green Tea Supplement On Cardiovascular Risk Factors
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: men who have Body Mass Index(BMI) between 25 to 35 kg/m2; age between 27 to 42; lack of weight loss reduction; lack of any operation in spinal cord; lack of chronic backache; lack of deformity; non-smoker; lack of asthma history; lack of special disease and fracture Exclusion criteria: refusal from taking part in the research
Age
From 27 years old to 42 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
60 volunteers were randomly divided (lucky draw) to four groups of 15 subjects (15 subjects in each group)

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University, Mahallat Branch
Street address
Iran, Mahallat, Ayatollah khamenei Blvd, Daneshgah Street, Islamic Azad university, Mahallat Branch
City
Mahallat
Postal code
8159314855
Approval date
2014-03-11, 1392/12/20
Ethics committee reference number
05.7425

Health conditions studied

1

Description of health condition studied
Cardiovascular Disease
ICD-10 code
I51.9
ICD-10 code description
Heart disease, unspecified

2

Description of health condition studied
obesity
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified

Primary outcomes

1

Description
Glucose
Timepoint
Before Intervention and 8 Weeks After of Intervention
Method of measurement
Blood serum

2

Description
Tam Cholesterol
Timepoint
Before Intervention and 8 Weeks After of Intervention
Method of measurement
Blood serum

3

Description
Triglyceride
Timepoint
Before Intervention and 8 Weeks After of Intervention
Method of measurement
Blood serum

4

Description
Insulin Resistance Index
Timepoint
Before Intervention and 8 Weeks After of Intervention
Method of measurement
Calculation by formula

5

Description
Insulin
Timepoint
Before Intervention and 8 Weeks After of Intervention
Method of measurement
Blood serum

6

Description
LDL
Timepoint
Before Intervention and 8 Weeks After of Intervention
Method of measurement
Blood serum

7

Description
Body Mass Index (BMI)
Timepoint
Before Intervention and 8 Weeks After of Intervention
Method of measurement
Calculation by formula

8

Description
Waist to Hip Ratio (WHR)
Timepoint
Before Intervention and 8 Weeks After of Intervention
Method of measurement
Calculation by formula

9

Description
Body Fat Percentage
Timepoint
Before Intervention and 8 Weeks After of Intervention
Method of measurement
Calculation by Tools

10

Description
HDL
Timepoint
Before Intervention and 8 Weeks After of Intervention
Method of measurement
Blood serum

Secondary outcomes

empty

Intervention groups

1

Description
Weight Training group: The Weight Training includes 3 session per week by 70 to 80 percent intensity a maximum repeat during the 8 weeks
Category
Prevention

2

Description
green tea group: The green tea supplement consisted of three 500 mgs pills of standard green tea leaf per day
Category
Prevention

3

Description
Weight Training along with the green tea group: The Weight Training includes 3 sessions per week by 70 to 80 percent intensity a maximum repeat during the 8 weeks. The green tea supplement consisted of three 500 mgs pills of standard green tea leaf per day
Category
Prevention

4

Description
Control group: participants have not received any exercise and green tea during the trials
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad university, Mahallat Branch
Full name of responsible person
Jalal Poorfakhimi Abarghui
Street address
Iran, Mahallat, Ayatollah khamenei Blvd, Daneshgah Street, Islamic Azad University, Mahallat Branch
City
Mahallat

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Islamic Azad University, Mahallat Branch
Full name of responsible person
Amir Teimur Rafii
Street address
Iran, Mahallat, Ayatollah khamenei Blvd, Daneshgah Street, Islamic Azad University, Mahallat Branch
City
Mahallat
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, Islamic Azad University, Mahallat Branch
Proportion provided by this source
100
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
Islamic Azad university, Mahallat Branch
Full name of responsible person
Bahram Abedi
Position
PHD
Other areas of specialty/work
Street address
Iran, Mahallat, Ayatollah khamenei Blvd, Daneshgah Street, Islamic Azad University, Mahallat Branch
City
Mahallat
Postal code
Phone
+98 86 4325 7554
Fax
Email
abedi_bahram2000@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad university, Mahallat Branch
Full name of responsible person
Jalal Poorfakhimi Abarghui
Position
master of science
Other areas of specialty/work
Street address
Iran, Mahallat, Ayatollah khamenei Blvd, Daneshgah Street, Islamic Azad University, Mahallat Branch
City
Mahallat
Postal code
Phone
+98 31 3522 6158
Fax
Email
aminix111@Gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Said Amini Rarani
Position
Master of Science
Other areas of specialty/work
Street address
NO127, 22 Bahman alley, Jey st, Isfahan, Iran
City
Isfahan
Postal code
8159314853
Phone
+98 31 3522 6158
Fax
+98 31 3522 6158
Email
aminix11@gmail.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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