Effects of concurrent training combine with green tea consumption on the level of blood lipids, fasting blood glucose and body composition in overweight and obese postmenopausal women
Assessing the effects of six weeks concurrent training combine with green tea consumption on level of blood lipids, fasting blood glucose and body composition in overweight and obese postmenopausal women
Design
clinical trail with parallel groups
Settings and conduct
Through the postmenopausal women’s of Qazvin city, 20 volunteers women will be select and randomly assign into two groups and each group consist of 10 persons including: experimental (concurrent training combine with green tea consumption) and control. Participants in the experimental group will done exercise 3 times per week according to recommendations of American college of sport medicine and eating green tea three time per day.
Participants/Inclusion and exclusion criteria
Inclusion criteria: postmenopausal women with age ranges of 50-59 years that at least 48 months has been passed from last menstruation period and don't have metabolic or orthopedic problems.
Exclusion criteria: sensitivity to green tea
Intervention groups
Experimental group: sex weeks intervention, three times per week concurrent aerobic- resistance training combine with daily consumption of green tea
Control group: no intervention
Main outcome variables
Serum level of triglyceride; cholesterol; LDL-C; HDL-C
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151209025449N3
Registration date:2018-02-13, 1396/11/24
Registration timing:retrospective
Last update:2018-02-13, 1396/11/24
Update count:0
Registration date
2018-02-13, 1396/11/24
Registrant information
Name
Fatemeh Izaddoust
Name of organization / entity
Islamic Azad University Rasht Branch
Country
Iran (Islamic Republic of)
Phone
-
Email address
izaddoust@iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-22, 1396/06/31
Expected recruitment end date
2017-10-06, 1396/07/14
Actual recruitment start date
2017-10-01, 1396/07/09
Actual recruitment end date
2017-10-15, 1396/07/23
Trial completion date
empty
Scientific title
Effects of concurrent training combine with green tea consumption on the level of blood lipids, fasting blood glucose and body composition in overweight and obese postmenopausal women
Public title
Effects of concurrent training combine with green tea consumption in overweight and obese postmenopausal women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
overweight and obese postmenopausal women
Age ranges of 50-59 that at least 48 months was passed since last menses
Not have orthopedic or metabolic disorders
Not have diet in the last 6 month
Exclusion criteria:
Have allergy to green tea
More than three sessions absence from the training
Do not consume more than four servings of green tea
Age
From 50 years old to 59 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of samples to experimental and control groups- Lottery
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
-
Approval date
2017-09-18, 1396/06/27
Ethics committee reference number
IR.IAU.RASHT.REC.1396.105
Health conditions studied
1
Description of health condition studied
Overweight and obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
2
Description of health condition studied
postmenopausal women
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Triglyceride
Timepoint
Before and 48 hour after the end of interventions
Method of measurement
Serum level using photometric method
2
Description
cholesterol
Timepoint
Before and 48 hour after the end of interventions
Method of measurement
Serum level using photometric method
3
Description
LDL-C
Timepoint
Before and 48 hour after the end of interventions
Method of measurement
Serum level using enzymatic method
4
Description
HDL-C
Timepoint
Before and 48 hour after the end of interventions
Method of measurement
Serum level using enzymatic method
5
Description
Fasting blood glucose
Timepoint
Before and 48 hour after the end of interventions
Method of measurement
Serum level using photometric method
Secondary outcomes
1
Description
Body composition
Timepoint
Before and after the end of interventions
Method of measurement
Using by measuring body mass index, waist to hip ratio and body fat percent
Intervention groups
1
Description
Intervention group: six weeks intervention including three sessions per week aerobic- resistance training and daily consumption of green tea
Category
Prevention
2
Description
Control group: No intervention will be conducting.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mellat Park, Qazvin, Qazvin, Iran
Full name of responsible person
Elahe heydari
Street address
Mellat Park, Qazvin, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
-
Phone
+98 13 3385 6174
Email
fa.izaddoust@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 Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
-
Phone
+98 13 3385 6174
Email
fa.izaddoust@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Private
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Zahra Hojjati Zidashti, Elahe heydari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
-
Phone
-
Email
z_hoj@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Zahra Hojjati Zidashti
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
-
Phone
-
Email
z_hoj@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Izaddoust
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
-
Phone
+98 13 3385 6174
Email
fa.izaddoust@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