Protocol summary

Summary
The purpose of this study is to evaluate the effect of endurance training and ginger consumption on lipid peroxidation and some indicators of cellular damage in sedentary people of in a randomized single-blinded clinical trial design. 120 sedentary male students are students of Shahrood University of Technology and according to inclusion criteria such as people between the ages 30-32 year old, healthy, nonsmokers and non-athlete people and exclusion criteria such as athlete people with use of medicine, high blood pressure and diabetes or non-compliance with treatment and after being inform about the aim of present investigation and signed an informed consent form will randomly assign into four intervention groups, intervention group 1, people with use of ginger supplementation powder that ingest 60 ginger supplementation capsules (two capsules contain 500 milligram ginger powder) during one month, intervention group 2, people with use of placebo (two capsules filled with 500 milligram starch during one month), intervention group 3, people with use of ginger and regular endurance training for three days per week during one month, intervention group 4, people with use of placebo and regular endurance training.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016011221412N4
Registration date: 2016-06-03, 1395/03/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-06-03, 1395/03/14
Registrant information
Name
Hamid Kalalian Moghadam
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
h.kalalian@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2014-02-19, 1392/11/30
Expected recruitment end date
2014-06-15, 1393/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of endurance training and ginger consumption on lipid peroxidation and some indicators of cellular damage in Sedentary people
Public title
Effect of endurance training and ginger on lipid peroxidation in Sedentary people
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: male gender between the ages 30-32 year old; healthy, nonsmokers and non-athlete people; with BMI less than 30. Exclusion criteria: athlete people with normal medicine usage; any history of disease such respiratory cardiac; high blood pressure; use of smoking
Age
From 30 years old to 32 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 120
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 Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, Haftom Tir Square
City
Shahroud
Postal code
Approval date
2014-06-11, 1393/03/21
Ethics committee reference number
93/8166

Health conditions studied

1

Description of health condition studied
Routine general health check-up of students
ICD-10 code
Z10.8
ICD-10 code description
Routine general health check-up of other defined subpopulations

Primary outcomes

1

Description
Creatine kinase level
Timepoint
After and before one month of continuous treatment
Method of measurement
Blood test by using a Pars Azmoon biochemical kit (Pars Azmoon Co., Tehran, Iran).

2

Description
Malondialdehyde (MDA) level
Timepoint
After and before one month of continuous treatment
Method of measurement
Blood test by using thiobarbituric acid method

3

Description
Lactate Dehydrogenase (LDH)
Timepoint
After and before one month of continuous treatment
Method of measurement
Blood test by using a Pars Azmoon biochemical kit (Pars Azmoon Co., Tehran, Iran).

Secondary outcomes

empty

Intervention groups

1

Description
intervention group 1, 30 healthy male students that ingest two capsules contain 500 milligram ginger powder each day after breakfast and dinner during one month
Category
Other

2

Description
intervention group 2, 30 healthy male students that ingest two capsules contain 500 milligram starch each day after breakfast and dinner during one month
Category
Placebo

3

Description
intervention group 3, 30 healthy male students that ingest two capsules contain 500 milligram ginger powder each day after breakfast and dinner with regular endurance training during one month
Category
Other

4

Description
intervention group 4, 30 healthy male students that ingest two capsules contain 500 milligram starch each day after breakfast and dinner with regular endurance training during one month
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Dr. Hamid Kalalian Moghadam
Street address
Imam Hossein Hospital, Imam Street
City
Shahroud

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Dr. Hamid Kalalian Moghadam
Street address
Shahroud University of Medical Sciences, Haftom Tir Square, Shahroud
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Medical Sciences, Vice Chancellor for Research
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
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hamid Kalalian Moghadam
Position
Assistant Professor of Physiology,Shahroud University of Medical Sciences
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Haftom Tir Square, Shahroud
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
h.kalalian@shmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hamid Kalalian Moghadam
Position
Assistant Professor of Physiology,Shahroud University of Medical Sciences
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Haftom Tir Square, Shahroud
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
h.kalalian@shmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hamid Kalalian Moghadam
Position
Assistant Professor of Physiology,Shahroud University of Medical Sciences
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Haftom Tir Square, Shahroud
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
h.kalalian@shmu.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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