Protocol summary

Summary
This is a quasi-experimental, randomized, placebo controlled study. It aims to examine the effects of ginger supplement and high intensity interval training on serum levels of soluble intracellular adhesion molecule type 1, monocyte chemotactic protein type 1, and interlukine 10 in overweight women. Twenty-four healthy women who meet inclusion criteria (age between 20 to 30 years; body mass index between 25 to 29.9 kilogram/squared meter) will be randomly allocated into 3 groups. They involve ginger (n=8), train+ginger (n=8), and train+placebo (n=8). The groups will perform high intensity interval training for 10 weeks (40 meter maximal shuttle run, from 8 to 10 a.m.) and ginger consumption (3 gram of Vomigan Ginger tablet produced in Dineh Company, Iran, 1 gram before each meal with a glass of water) or placebo (3 gram of Gram Flour tablets produced in Dineh Company, Iran, 1 gram before each meal with a glass of water) on a daily basis. Effects of the interventions will be studied on soluble intracellular adhesion molecule type 1, monocyte chemotactic protein type 1, and interlukine 10 as primary outcome variables and on blood pressure, body fat percentage, Vo2max, cardiac structural and functional variables, and lipid profile as secondary outcome variables. Exclusion criteria include cardiovascular and respiratory problems; diabetes; high blood pressure; orthopaedic diseases; smoking; pregnancy; performance of regular exercise training during last year; and menstural disorder.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016051027836N1
Registration date: 2016-06-18, 1395/03/29
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-06-18, 1395/03/29
Registrant information
Name
Shila Nayebifar
Name of organization / entity
Birjand University
Country
Iran (Islamic Republic of)
Phone
+98 56 3223 8192
Email address
shila_neyebi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-06-30, 1395/04/10
Expected recruitment end date
2016-07-30, 1395/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of high intensity interval training and ginger supplement on serum levels of soluble intracellular adhesion molecule type 1, monocyte chemotactic protein type 1, and interlukine 10 in overweight women
Public title
Effects of exercise training and herbal medicine on inflammatory markers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Women aged between 20 to 30 years; having body mass index between 25 to 29.9 kilogram/squared meter Exclusion criteria: Having cardiovascular and respiratory problems; diabetes; high blood pressure; orthopedic diseases; smoking; pregnancy; regular exercise training during last year; having menstrual disorder
Age
From 20 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Birjand University of Medical Sciences
Street address
Ghaffari Street
City
Birjand
Postal code
9717853577
Approval date
2016-06-12, 1395/03/23
Ethics committee reference number
IR.BUMS.1395.28

Health conditions studied

1

Description of health condition studied
Overweight
ICD-10 code
E66.9
ICD-10 code description
Simple obesity NOS

Primary outcomes

1

Description
Interlukine 10
Timepoint
24 hours before the first session and 48 hours after the last training session at the end of 10 weeks of intervention
Method of measurement
Serum Blood Sampling, Special Kits

2

Description
Soluble Interacellular Adhesion Molecule type 1
Timepoint
Twenty four hours before the first training session and forty eight hours after the last training session at the end of 10 weeks of intervention
Method of measurement
Serum Blood Sampling, Special Kits

3

Description
Monocyte Chemotactic Protein type 1
Timepoint
Twenty four hours before the first training session and forty eight hours after the last training session at the end of 10 weeks of intervention
Method of measurement
Serum Blood Sampling, Special Kits

Secondary outcomes

1

Description
Blood Pressure
Timepoint
Twenty four hours before the first training session and forty eight hours after last trainnig session at the end of 10 weeks of intervantion
Method of measurement
Rishter Blood Pressure Barometer, milimeter Hg

2

Description
Body Fat Percentage
Timepoint
Twenty four hours before the first training session and forty eight hours after last trainnig session at the end of 10 weeks of intervantion
Method of measurement
Yagami Caliper made in Japan

3

Description
Vo2max (Maximal Oxygen Consumption)
Timepoint
Twenty four hours before the first training session and forty eight hours after last trainnig session at the end of 10 weeks of intervantion
Method of measurement
Bruce test on treadmill

4

Description
Cardiac structural and functional variables
Timepoint
Twenty four hours before the first training session and forty eight hours after last trainnig session at the end of 10 weeks of intervantion
Method of measurement
Heart Echocardiographic System

5

Description
Lipid Profile
Timepoint
Twenty four hours before the first training session and forty eight hours after last trainnig session at the end of 10 weeks of intervantion
Method of measurement
Serum Blood Sampling

Intervention groups

1

Description
Train + Placebo Intervention Group: Doing high intensity interval training (40 meters maximal shuttle run, 4 repetitions in the first week and 8 repetitions in the 10th week, together with daily intake of gram flour placebo tablets produced in Dineh Company, Iran, 1 gram before each meal with 1 glass of water for 10 weeks)
Category
Prevention

2

Description
Ginger + Train Intervention group: Doing high intensity interval training (40 meters maximal shuttle run, 4 repetitions in the first week to 10 repetitions in the 10th week, together with daily intake of Vomigan ginger tablets produced in Dineh Company, Iran, 1 gram before each meal with 1 glass of water for 10 weeks)
Category
Prevention

3

Description
Ginger Group: Daily intake of 3 grams of Vomigan Ginger tablet produced in Dineh Company, Iran, 1 gram before each meal with 1 glass of water for 10 weeks without doing physical training
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Birjand University
Full name of responsible person
Shila Nayebifar
Street address
Birjand University, Shokat Abad
City
Birjand

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Shila Nayebifar
Street address
50 P, Moallem 11, Moallem Street, Birjand, Iran
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Shila Nayebifar
Position
Phd Student of Exercise Physiology
Other areas of specialty/work
Street address
Faculty of Physical Education, Shokatabad Pardis, Birjand University
City
Birjand
Postal code
Phone
+98 56 3223 8192
Fax
Email
shila_neyebi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University
Full name of responsible person
Shila Nayebifar
Position
Phd Student of Exercise Physiology.
Other areas of specialty/work
Street address
Faculty of Physical Education, Shokatabad Pardis, Birjand University
City
Birjand
Postal code
Phone
+98 56 3223 8192
Fax
Email
shila_neyebi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Birjand University
Full name of responsible person
Shila Nayebifar
Position
Phd Student of Exercise Physiology
Other areas of specialty/work
Street address
Faculty of Physical Education, Shokatabad Pardis, Birjand University
City
Birjand
Postal code
Phone
+98 56 3223 8192
Fax
Email
shila_neyebi@yahoo.comm; broozgar@bums.ac.ir
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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