Protocol summary

Summary
Muscle damage caused by free radicals may be produced during intense exercise. Antioxidants prevent the oxidative stresses induced by intense physical exercise and after exercise helps to go back to initial conditions. Thus, antioxidant supplementation in athletes can be useful. Pomegranate contains a variety of sugars, organic acids, alkaloids, poly-phenols, flavonoids, anthocyanins and vitamins that can be effective in improving the antioxidant capacity. This study investigated the effects of pomegranate juice consumption with endurance exercise on oxidative stress and inflammatory markers and body composition of muscle damage is done. Procedure: in this study, double-blind, placebo-controlled clinical trial to be conducted 30 healthy young men were randomly divided into control and experimental groups of 15 persons. Inclusion criteria: men; willingness to participate in the study; no use of antioxidant supplementation in the past one month; age between 20 to 25 years old and BMI between 20-25. Exclusion criteria: being athlete; smoking; catching diseases that require special treatment; unwillingness to continue the study. Interventions consisted of 250 mL of pomegranate juice naturally matched control group of 250 cc oil pomegranate juice and physical activity to be 3 times a week, each time for 90 minutes of aerobic exercise as running with the intensity of 70% VO2 max is 8 week is done. Before and after intervention in both groups fasting blood sample for testing creatine kinase, lactate dehydrogenase, malondialdehyde, CRP is taken. Body composition parameters measured by the device bioimpedance the results of both groups are analyzed and compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014051910826N10
Registration date: 2014-07-18, 1393/04/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-07-18, 1393/04/27
Registrant information
Name
Azadeh Nadjarzadeh
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 202 2817
Email address
azadnajarzadeh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2014-07-01, 1393/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of pomegranate juice consumption associated with endurance exercise on oxidative stress, indices of muscle damage, inflammation and body composition in healthy young men
Public title
Effects of pomegranate juice consumption associated with endurance exercise on oxidative stress, indices of muscle damage, inflammation and body composition in healthy young men
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: men; willingness to participate in the study; no use of antioxidant supplementation in the past one month; age between 20 to 25 years old and BMI between 20-25. Exclusion criteria: being athlete; smoking; catching diseases that require special treatment; unwillingness to continue the study.
Age
From 20 years old to 25 years old
Gender
Male
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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The University of Medical Science ( martyr Sadooghi)
Street address
Yazd, Imam Hossein Square
City
yazd
Postal code
Approval date
2013-12-21, 1392/09/30
Ethics committee reference number
17/1/187844/پ

Health conditions studied

1

Description of health condition studied
muscle damage
ICD-10 code
M-63
ICD-10 code description
Disorders of muscle in diseases classified elsewhere

Primary outcomes

1

Description
Blood Creatine Kinase
Timepoint
Before & after intervention
Method of measurement
Level of enzyme activity by photometric method

Secondary outcomes

1

Description
malondialdehide
Timepoint
before & after intervention
Method of measurement
blood Biochemical test

2

Description
CRP
Timepoint
before & after intervention
Method of measurement
blood Biochemical test

3

Description
Percent body fat
Timepoint
before & after intervention
Method of measurement
Byvampdans Device

4

Description
LDH
Timepoint
before & after intervention
Method of measurement
blood Biochemical test

5

Description
Percentage of lean body mass
Timepoint
Before & after intervention
Method of measurement
Bioampedans Device

6

Description
weight
Timepoint
before & after intervention
Method of measurement
seca Balance

7

Description
Height
Timepoint
before & after intervention
Method of measurement
Tape meter

8

Description
BMI
Timepoint
before & after intervention
Method of measurement
kgr/m2 ,seca Balance and tape meter

9

Description
cholestrol
Timepoint
before & after intervention
Method of measurement
blood Biochemical test

10

Description
fasting blood sugar
Timepoint
before & after intervention
Method of measurement
blood Biochemical test

11

Description
triglycerides
Timepoint
before & after intervention
Method of measurement
blood Biochemical test

12

Description
HDL
Timepoint
before & after intervention
Method of measurement
blood Biochemical test

13

Description
LDL
Timepoint
before & after intervention
Method of measurement
blood Biochemical test

14

Description
blood presure
Timepoint
before & after intervention
Method of measurement
manometer

Intervention groups

1

Description
250 cc natural pomegranate juice daily to 8 weeks of the intervention group and Physical activity three times a week, each time for 90 minutes of aerobic exercise intensity of 70% VO2 max for Jogging For the intervention group
Category
Other

2

Description
Daily to 250 mL of tap water containing Essence and color of pomegranate for 8 weeks and Physical activity three times a week, each time for 90 minutes of aerobic exercise intensity of 70% VO2 max for Jogging For the control group
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences
Full name of responsible person
Ehsan Bayat
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research services of shahid sadoughi university
Full name of responsible person
Dr. Hassan Mozafari
Street address
Yazd,bahonar square
City
yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research services of shahid sadoughi 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
Department of nutrition, School of public health, Shahid Sadoughi University
Full name of responsible person
Dr. Azade Najarzadeh
Position
PhD, Assistant professor
Other areas of specialty/work
Street address
School of public health, Imam Hossein square
City
Yazd
Postal code
Phone
+98 35 1624 0696
Fax
Email
azadnajarzadeh@ssu.ac.ir; azmm1383@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of nutrition, School of public health
Full name of responsible person
Dr. Azade Najarzadeh
Position
PhD, Assistant professor
Other areas of specialty/work
Street address
School of public health, Imam Hossein square
City
Yazd
Postal code
Phone
+98 35 1624 0696
Fax
Email
azadnajarzadeh@ssu.ac.ir; azmm1383@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Ehsan Bayat
Position
Msc student, Department of nutrition, School of public health,
Other areas of specialty/work
Street address
Shahid Sadoughi University of Medical Sciences
City
Yazd
Postal code
Phone
Fax
Email
ehsan.bayat67@gmail.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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