Protocol summary
-
Study aim
-
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
-
Main outcome variables
-
Body fat, irisin; interleukin-6; adiponectin; tumor necrosis factor-alpha; C-reactive protein; dietary intake
General information
-
Reason for update
-
Editing the name of ethic committee
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20151025024699N3
Registration date:
2019-08-05, 1398/05/14
Registration timing:
retrospective
Last update:
2021-02-12, 1399/11/24
Update count:
1
-
Registration date
-
2019-08-05, 1398/05/14
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2018-04-03, 1397/01/14
-
Expected recruitment end date
-
2018-07-05, 1397/04/14
-
Actual recruitment start date
-
2018-04-03, 1397/01/14
-
Actual recruitment end date
-
2018-09-05, 1397/06/14
-
Trial completion date
-
2018-11-21, 1397/08/30
-
Scientific title
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
1
-
Sponsor
-
-
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
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.
-
Comments
-