Protocol summary

Study aim
Study of the effect of supplementation were of L-carnitine and curcumin and changes in superoxide dismutase, glutathione peroxidase, catalase and glutathione reductase enzymes through an intensity session training.
Design
A clinical trial is conducted in two groups using two complementary types in a simple random manner
Settings and conduct
First the researcher said : how to do research and describe all the details for the subjects, then satisfaction was obtained.After conducting a study of guidance and coordination with Farhangian University of Nassiba campus,participants attended the venue and the study started with their health was confirmed by the current doctor.
Participants/Inclusion and exclusion criteria
Lack of history of previous illness and injury, lack of susceptibility to supplements, low blood pressure, cardiovascular disease
Intervention groups
Two groups: Supplements of L-Carnitine and Curcumin An 14 aufeinanderfolgenden Tagen erhielten die Probanden Ergänzungsergänzungen، On average, 1000 mg per day of El Carnitine and Curcumin.The completion of the supplementary course, and after the implementation of the protocol Blood samples were taken And changes in enzymes were investigated
Main outcome variables
Creation changes At the time of the foundation and after the supplementation, after the activity:superoxide dismutase, glutathione peroxidase, catalase and glutathione reductase enzymes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171210037809N2
Registration date: 2018-12-19, 1397/09/28
Registration timing: retrospective

Last update: 2018-12-19, 1397/09/28
Update count: 0
Registration date
2018-12-19, 1397/09/28
Registrant information
Name
farah nameni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8843 6932
Email address
f.nameni@yahoo.co.uk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of short term supplementation with curcumin on antioxidant enzymes (SOD,GR, GPX , CAT)
Public title
the effect of derivate of curcumin on immune system
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
ALL POEPLE AFTER 17 YEARS OLD
Exclusion criteria:
Age
From 19 years old to 25 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
The statistical population included 254 female students of Physical Education at Farhangian University that In the last six months they had 4-3 sessions per week.Due to the applied and experimental nature of the research,from the above society, 30 people were selected by simple random method,and after filling out the health questionnaire and having appropriate indicators in the research participated and in 2 supplementation groups ( l -carnitine , corcumin) set.Entry criteria were lack of history of previous illness and injury, lack of susceptibility to supplements, low blood pressure, cardiovascular disease.
Blinding (investigator's opinion)
Single blinded
Blinding description
NARMAL
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of the Physical Education Research Institute of the Ministry of Science and Res
Street address
No. 3، 5th Alley - Abbas abad /Mir emad
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2018-08-14, 1397/05/23
Ethics committee reference number
IR.SSRI.REC.1397.223

Health conditions studied

1

Description of health condition studied
We have no illness
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Changes of the activity of glutathione peroxidase and superoxide dismutase,glutathione redoctase, catalase
Timepoint
In the base / after the completion of the supplementary period / immediately after the exercise
Method of measurement
Using a special kit and an autoanalyzer device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: curcumin 14 consecutive days, an average of 1000 mg per day curcumin،Intervention group:
Category
N/A

2

Description
Control group: without corcumin supplementation
Category
N/A

3

Description
Intervention group2: Intervention group: L- Carnitine , 14 consecutive days, an average of 1000 mg per day
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Farhangian University
Full name of responsible person
Farah Nameni
Street address
Ashrafi Esfahani / Fereshtehgan
City
Tehran
Province
Tehran
Postal code
1463773111
Phone
+98 21 4425 4026
Fax
Email
farahnameni@yahoo.com
Web page address
https://nasibeh.cfu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Pyman Azizi
Street address
Sharak Nagshe Jahan/ Pishva /Varamin
City
Tehran
Province
Tehran
Postal code
1637876791
Phone
+98 21 3672 5011
Email
info@iauvaramin.ac.ir
Web page address
https://www.linkedin.com/company/iau-varamin-pishva
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farah Nameni
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Shahrak Naghshe Jahan/Pishva/Varamin
City
Tehran
Province
Tehran
Postal code
1637876791
Phone
+98 21 8843 6932
Email
info@iauvaramin.ac.ir
Web page address
https://www.linkedin.com/company/iau-varamin-pishva

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farah Nameni
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Shahrak Naghshe Jahan/ Pishva/ Varamin/
City
Tehran
Province
Tehran
Postal code
1637876791
Phone
+98 21 8843 6932
Fax
Email
f.nameni@yahoo.co.uk

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farah Nameni
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Shahrak Naghshe Jahan/Pishva /Varamin
City
Tehran
Province
Tehran
Postal code
1637876791
Phone
+98 21 8843 6932
Fax
Email
f.nameni@yahoo.co.uk

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...