Assessing the effect of aerobic exercise and green tea supplementation on body composition, and cardio metabolic risk factors of overweight and obese women
Design
In this research, 39 overweight and obese women will be select and randomly divide in to three equal groups including aerobic- group, aerobic combine with green tea consumption and control groups.
Settings and conduct
The present study is a semi-experimental study on the women of city of Lasht-e Nesha . Aerobic training will be conducting three time per week and green tea will be consuming on a daily basis. The study duration will be eight weeks. The level of fasting blood sugar, blood lipid, Rest heart rate, blood pressure and body composition will be measuring before and after the end of interventions period
Participants/Inclusion and exclusion criteria
The woman age ranges of 22-34 years old have overweight or obese not have cardiovascular or orthopedic disorders No regular exercise
Intervention groups
Aerobic training group: eight weeks, three times per week, each session consist of 80-90 min , with intensity 40- 80% target heart rate
Aerobic training combine with green tea consumption: Aerobic training combine with green tea consumption: eight weeks, three time training (Similar to aerobic training group) combine with daily consumption of 33 mg green tea (After three main meal)
Control group: no intervention will be conducting.
Main outcome variables
fasting blood sugar, blood lipid, Rest heart rate, blood pressure and body composition
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150531022498N17
Registration date:2018-02-07, 1396/11/18
Registration timing:retrospective
Last update:2018-02-07, 1396/11/18
Update count:0
Registration date
2018-02-07, 1396/11/18
Registrant information
Name
Ramin Shabani
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 13 3375 2715
Email address
shabani@iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-08-21, 1395/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of aerobic exercise and green tea supplementation on body composition, and cardio metabolic risk factors of overweight and obese women.
Public title
Effect of aerobic exercise and green tea supplementation in overweight and obese women.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The woman age ranges of 22-34 years old have overweight or obese
not have cardiovascular or orthopedic disorders
No regular exercise
Exclusion criteria:
More than three session absence from the training
Age
From 20 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
39
Randomization (investigator's opinion)
Randomized
Randomization description
En Assigning samples using Simple random-lottery method
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 Islamic Azad University Rasht Branch
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
۴۱۴۷۶۵۴۹۱۹
Approval date
2016-09-18, 1395/06/28
Ethics committee reference number
IR.IAU. RASHT.REC.1395.25
Health conditions studied
1
Description of health condition studied
Overweight and obese women
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Fasting Blood Glucose
Timepoint
Before and after the end of interventions
Method of measurement
Serum levels using Glucose oxidase / per oxidase method (mg/dl)
2
Description
Total cholesterol
Timepoint
Before and after the end of interventions
Method of measurement
Serum levels using photo metric method (mg/dl)
3
Description
Low density cholesterol
Timepoint
Before and after the end of interventions
Method of measurement
Serum levels using photo metric method (mg/dl)
4
Description
High density cholesterol
Timepoint
Before and after the end of interventions
Method of measurement
Serum levels using photo metric method (mg/dl)
5
Description
Triglyceride
Timepoint
Before and after the end of interventions
Method of measurement
Serum levels using photo metric method (mg/dl)
6
Description
Rest heart rate
Timepoint
Before and after the end of interventions
Method of measurement
By measuring the pulse
7
Description
Blood pressure
Timepoint
Before and after the end of interventions
Method of measurement
Pressure device
Secondary outcomes
1
Description
Body composition
Timepoint
Before and after the end of interventions
Method of measurement
Using weight, body mass index, waist to hip ratio and fat percent
Intervention groups
1
Description
Aerobic training group: eight weeks, three times per week, each session consist of 80-90 min , with intensity 40- 80% target heart rate
Category
Prevention
2
Description
Aerobic training combine with green tea consumption:Aerobic training combine with green tea consumption: eight weeks, three time training (Similar to aerobic training group) combine with daily consumption of 33 mg green tea (After three main meal)
Category
Prevention
3
Description
Control group: no intervention will be conducting.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Lasht-Nesha city
Full name of responsible person
Hajar Amozadeh
Street address
Lasht-Nesha, Guilan, Iran
City
Lasht-Nesha
Province
Guilan
Postal code
9194147654
Phone
+98 13 3342 4080
Email
Hajar.amozadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali delpasand
Street address
Islamic Azad University Rasht Branch, Taleshan Bredge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 4080
Email
marzieh.nazari.v@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hajar Amozadeh
Position
Master
Latest degree
Master
Other areas of specialty/work
Physical education
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654119
Phone
+98 13 3342 4080
Email
Hajar.amozadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ramin shabani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
physical education
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
41447654919
Phone
+98 13 3375 2715
Email
dr.ramin.shabani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Marzieh nazari
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Physical education
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 4080
Email
marzieh.nazari.v@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available