The aim of this study is to investigate the effects of green tea extract supplementation on exercise induced changes in body composition, irisin, adipokines and pro-inflammatory cytokines in inactive overweight men and women.
Design
Study design: Randomized double-blinded controlled clinical trial. Blinding is carried out for subjects and researchers and randomization will done using quadratic block. Statistical software (Minitab) will use to perform randomized block. Population and sample size: 75 overweight sedentary men and women who are not participated in any regular training program for at least 6 months before the study.
Settings and conduct
75 overweight sedentary men and women who are eligible and are referred to a sport medicine clinic affiliated to Ferdowsi University of Mashhad, Mashhad, Iran will be selected. Blinding is carried out for subjects and researchers and randomization will done using quadratic block. Statistical software (Minitab) will use to perform randomized block.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Overweight men and women aged 30 to 50 years without participating in any regular training program
Exclusion criteria:
People with obesity, recent infections, joint and bone injuries, and symptoms of metabolic disease.
Intervention groups
Intervention 1: received one 500 mg green tea extract capsule, 1 hour before each exercise training session, for wight weeks
Intervention 2: exercise training including aerobics, circuit training, and fast walking or jogging, 3 times/wk with a moderate intensity
Intervention 3: received one capsule containing chickpea flour, for wight weeks
Effect of green tea extract and endurance training on inflammatory markers, adiponectin and irisin level
Public title
Effect of green tea extract and endurance training on inflammation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 30-50
BMI=25-30
Don’t taking the glucose and lipid- lowering drugs
Interesting in participation in research
Without any metabolic disease
No smoking
No alcoholism
Not taking supplements (including vitamins, minerals, ergogenic aids) and medication for at least 2 months before the study
Not participating in any regular training program for at least 6 months before the study
Exclusion criteria:
Use of immune system suppressor drugs 6 mounts before research
Women with polycystic ovary syndrome
Obesity (BMI ≥ 30 kg/m2)
No interesting for participation
Recent infections
Joint and bone injuries
Metabolic disease
Age
From 30 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
75
Actual sample size reached:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will done using quadratic block. Statistical software (Minitab) will use to perform randomized block.
Blinding (investigator's opinion)
Double blinded
Blinding description
Study design: Parallel double-blind (both patients and researchers) clinical trial.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Ferdowsi University of Mashhad, Iran
Street address
Ferdowsi University of Mashhad, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9596116856
Approval date
2018-04-09, 1397/01/20
Ethics committee reference number
IR.IAU.NEYSHABUR.REC.1397.010
Health conditions studied
1
Description of health condition studied
Healthy, overweight
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Irisin
Timepoint
Before and two weeks after intervention
Method of measurement
ELISA
2
Description
Interleukin 6
Timepoint
Before and two weeks after intervention
Method of measurement
ELISA
3
Description
Tumor necrosis factor alpha
Timepoint
Before and two weeks after intervention
Method of measurement
ELISA
4
Description
Adiponectin
Timepoint
Before and two weeks after intervention
Method of measurement
ELISA
5
Description
C-reactive protein
Timepoint
Before and two weeks after intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
Body fat
Timepoint
Before and two weeks after intervention
Method of measurement
Body fat Analyzer
2
Description
Dietary intake
Timepoint
Before and two weeks after intervention
Method of measurement
Food record questionnaire
Intervention groups
1
Description
Intervention group: received one 500 mg green tea extract capsule, 1 hour before each exercise training session, for eight weeks
Category
Prevention
2
Description
Intervention group: exercise training including aerobics, circuit training, and fast walking or jogging, 3 times/wk with a moderate intensity, for eight weeks
Category
Lifestyle
3
Description
Control group: received one capsule containing chickpea flour, for eight weeks
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Vice chancellor for Research, Ferdowsi University of Mashhad
Full name of responsible person
Dr. Amir Rashidlamir
Street address
Physical education faculty, Ferdowsi University of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9596116856
Phone
+98 51 3880 5407
Email
rashidlamir@um.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Ferdowsi University of Mashhad, Iran.
Full name of responsible person
ِDr. Amir Rashidlamir
Street address
Ferdowsi University of Mashhad, Azadi Sq
City
Mashhad
Province
Razavi Khorasan
Postal code
9596116856
Phone
+98 51 3880 5407
Email
rashidlamir@um.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, Ferdowsi University of Mashhad, Iran.
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
Ferdowsi University of Mashhad
Full name of responsible person
Reza Bagheri
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Azadi square, Ferdowsi University of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9596116856
Phone
+98 51 3521 4043
Email
will.fivb@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Reza Bagheri
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Azadi square, Ferdowsi University of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9596116856
Phone
+98 51 3521 4043
Email
will.fivb@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Damoon Ashtary-Larky
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3443 6106
Email
ashtary.d@ajums.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
itle and more details about the data/document
Publication of protocol study in form of the article and
also data publication in the original article. The total
potential data can be shared after unidentifiable
subjects.
When the data will become available and for how long
6 months after the publication of results
To whom data/document is available
All researchers who have access to clinical trials
databases
Under which criteria data/document could be used
The only way for using the data is after the publication of
the article in the indexed ISI journal.
From where data/document is obtainable
Via database websites such as PubMed and google
scholar and via email address:
damoon_ashtary@yahoo.com
What processes are involved for a request to access data/document
The original article reaches the requestor by email within
a maximum of one week.