Protocol summary

Summary
The aim of the present study is determining the effect of 10 weeks of high intensity interval training with consuming green tea supplementation on Sirtuin-1 (SIRT1) and Peroxisome Proliferate-Activated Receptor Gamma Co activator 1-Alpha (PGC-1a) in overweight women. Thirty non-athlete females having overweight randomly divided into 3 consistent and equal groups including high intensity interval training along with supplements group, High intensity interval training plus placebo and supplementary group. The training program included 3 sessions in a week for 10 weeks with the intensity of 85-95% maximum heart rate. The groups consuming green tea consumed 3 tablets of 500 mg after each main meal for 10 weeks. Venous blood samples before test and post test was used for measuring SIRT1 and PGC-1a.Body mass index, fat percentage and the weight of the participants were assessed before and after intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015121425524N1
Registration date: 2016-04-01, 1395/01/13
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-04-01, 1395/01/13
Registrant information
Name
Elham Ghasemi
Name of organization / entity
Birjand University
Country
Iran (Islamic Republic of)
Phone
+98 56 3242 4947
Email address
eghasemi@birjand.ac.ir
Recruitment status
Recruitment complete
Funding source
Thesis, Vice chancellor 0f Research, Birjand University
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of 10 weeks of high intensity interval training and green tea supplementation on serum levels of Sirtuin 1, PGC-1α and Catalase in overweight women
Public title
The Effect of 10 weeks of high intensity interval training and green tea supplementation on serum levels of Sirtuin 1, PGC-1α and Catalase in overweight women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Lack of participation in regular physical activity; lack of any recent chronic disease; non-smoking; lack of cardiovascular disease, metabolic or respiratory diseases; not taking any herbal supplement or drug or chemical antioxidant and extreme sports in the last 6 months. Exclusion criteria: lack of regular participation in exercise; lack of regular use of supplements; Taking herbal supplements and antioxidant drug or chemical or strenuous exercise during the study period.
Age
From 19 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Birjand, South Khorasan
City
Birjand
Postal code
Approval date
2016-02-08, 1394/11/19
Ethics committee reference number
ir.bums.1394.312

Health conditions studied

1

Description of health condition studied
Overweight and Obesity
ICD-10 code
E65,E66,E6
ICD-10 code description
Localized adiposity, Obesity, Other hyperalimentation, Sequelae of hyperalimentation

Primary outcomes

1

Description
Sirtuin 1
Timepoint
Baseline and after 10 weeks
Method of measurement
ELISA

2

Description
PGC-1a
Timepoint
Baseline and after 10 weeks
Method of measurement
ELISA

Secondary outcomes

1

Description
Weight
Timepoint
Baseline and after 10 weeks
Method of measurement
Digital Balance

2

Description
Body mass index
Timepoint
Baseline and after 10 weeks
Method of measurement
Formula

3

Description
Fat percentage
Timepoint
Baseline and after 10 weeks
Method of measurement
Caliper and Jackson Pollock formula

Intervention groups

1

Description
The intervention group practice with supplements of green tea: consumption 10 weeks 500 mg Dinah green tea tablets three times a day , along with intensive interval training with intensity of 85-95% of maximum heart rate
Category
Placebo

2

Description
Intervention group supplements of green tea: consumption 500 mg Dinah green tea tablets for 10 weeks in three times a day.
Category
Placebo

3

Description
The intervention group placebo: 10 weeks of taking 500 mg starch powder tablets similar to green tea tablets three times daily.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Birjand University
Full name of responsible person
Doctor Mohammad Ismail Afzalpour
Street address
Birjand University, Birjand, South Khorasan
City
Birjand

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor Of Research, Birjand University
Full name of responsible person
Doctor Mohammad Ali Behdani
Street address
Birjand University, Birjand
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor Of Research, Birjand University
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
Birjand University
Full name of responsible person
Elham Ghasemi
Position
PhD Student In Exercise Physiology
Other areas of specialty/work
Street address
Birjand University, Birjand
City
Birjand
Postal code
Phone
+98 915 864 0703
Fax
Email
E.GHASEMI84@GMAIL.COM
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University
Full name of responsible person
Mohammad Ismail Afzalpour
Position
Professor
Other areas of specialty/work
Street address
Birjand University, Birjand, South Khorasan
City
Birjand
Postal code
Phone
+98 56 3220 2032
Fax
Email
afzalpour.me@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Birjand University
Full name of responsible person
Elham Ghasemi
Position
PhD Student In Exercise Physiology
Other areas of specialty/work
Street address
Birjand University, Birjand
City
Birjand
Postal code
Phone
+98 56 3242 4947
Fax
Email
Eghasemi20@yahoo.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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