Protocol summary

Summary
Objectives: An investigation of the immunomudulatory effects of intensive exercise and fish-oil supplement in elite paddlers. Design: A randomized double blind placebo-controlled, phase II design will be used for this study. Setting and conduct: The study will be performed in department of Immunology, School of Public Health, Tehran University of Medical Sciences. Participants: Twenty two elite competitive paddlers, all from the Iranian national dragon butt team will participate in our study. The main inclusion criteria: 18 to 30 years of age, non-smoking, agree to avoid sea foods throughout the study,sign informed consent. The main exclusion criteria: History of cardiovascular disease or diabetes, allergy to fish oil, appearance of intestinal side effects such as chronic and acute abdominal pains, diarrhea, and vomiting, acute fever and headache, consumption of anti-coagulation drugs such as aspirin or warfarin. Intervention: All subjects were randomly selected to receive the placebo (mineral oil, n=11) or supplementation (n=11) with fish oil in capsules (American,Vita Cost) of 6 gr daily, containing 3.6 gr of n-3 PUFA (2400 mg of eicosapentaenoic acid and 1200 mg of docohexaenoic acid per day) for 4 weeks. Blood samples (10 ml) will collected at the 48hr before beginning of the study and at the 48hr after end of supplementation period. Main outcome measures: The levels of different cytokines including TNF-alpha, IL-1, IL-6, IL-10, IFN-gamma, and IL-4 will be investigated in the supernatant of polyclonally stimulated peripheral blood mononuclear cells using enzyme-linked immunosorbent assay (ELISA) kits at the 48hr before beginning of the study and at the 48hr after end of supplementation period. Moreover, we will enumerate the frequencies of Th1 and Th2 cells in the peripheral blood of all subjects by flow cytometry.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014081618814N1
Registration date: 2014-12-26, 1393/10/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-12-26, 1393/10/05
Registrant information
Name
Farhad Jadidi-Niaragh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 88953021009821
Email address
f-jadidin@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2014-12-28, 1393/10/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Omega-3 supplementation on immune responses in elite paddlers
Public title
Effect of Omega-3 supplementation on immune responses in elite paddlers
Purpose
Basic scienece
Inclusion/Exclusion criteria
The main inclusion criteria: 18 to 30 years of age, non-smoking, agree to avoid sea foods throughout the study,sign informed consent. The main exclusion criteria: History of cardiovascular disease or diabetes, allergy to fish oil, appearance of intestinal side effects such as chronic and acute abdominal pains, diarrhea, and vomiting, acute fever and headache, consumption of anti-coagulation drugs such as aspirin or warfarin.
Age
From 18 years old to 30 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 22
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
Ethical Committee of Tehran University of Medical Sciences
Street address
Ethical Committee of Tehran University of Medical Sciences, Keshavarz boulevard, Tehran, PO Box 6446-14155, Iran
City
Tehran
Postal code
Approval date
2014-10-28, 1393/08/06
Ethics committee reference number
93-02-27-25916-128511

Health conditions studied

1

Description of health condition studied
It has not ICD10 code.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
age
Timepoint
prior to study
Method of measurement
Questionnaire

2

Description
Height
Timepoint
prior to study
Method of measurement
meter

3

Description
Weight
Timepoint
prior to study
Method of measurement
balance

4

Description
lean body mass
Timepoint
prior to study
Method of measurement
InBody-520 instrument

5

Description
Blood fat
Timepoint
prior to study
Method of measurement
laboratory

6

Description
maximal oxygen uptake
Timepoint
prior to study
Method of measurement
CASMED instrument

Secondary outcomes

1

Description
TNF-alpha level
Timepoint
48 hr before and after study period
Method of measurement
ELISA

2

Description
IL-1beta
Timepoint
48 hr before and after study period
Method of measurement
ELISA

3

Description
IL-6 level
Timepoint
48 hr before and after study period
Method of measurement
ELISA

4

Description
IFN-gamma level
Timepoint
48 hr before and after study period
Method of measurement
ELISA

5

Description
IL-4 level
Timepoint
48 hr before and after study period
Method of measurement
ELISA

6

Description
IL-10 level
Timepoint
48 hr before and after study period
Method of measurement
ELISA

7

Description
Th1 frequency
Timepoint
48 hr before and after study period
Method of measurement
Flow cytometry

8

Description
Th2 frequency
Timepoint
48 hr before and after study period
Method of measurement
Flow cytometry

Intervention groups

1

Description
Test group: subjects in test group will recievel 6.0 g/day fish-oil supplementation in capsules (American,Vita Cost) containing 3.6 g of n-3 polyunsaturate fatty acids containing 2400 mg of EPA and 1200 mg DHA for 4 weeks. Moreover, They will experience the increasing intensive exercise during the same time.Blood samples will be collected 48hr before and after study period.
Category
Other

2

Description
Placebo group: Subjects in placebo group will receive 6gr/day placebo capsules containing mineral oil purchased from Zahravi Pharmaceutical Inc. (Iran) for 4 weeks. Moreover, all subjects will experience the increasing intensive exercise. Blood samples will be collected 48hr before and after study period.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran sailing federetion
Full name of responsible person
Gholamreza Amini
Street address
Sailing tower, Azadi Sport Complex, Tehran-Karaj Highway, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Masud Yunesian
Street address
Vice chancellor for research, Tehran University of Medical Sciences, Keshavarz boulevard, Tehran, PO Box 6446-14155, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Farhad Jadidi-Niaragh
Position
PhD student of Immunology
Other areas of specialty/work
Street address
Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Keshavarz boulevard, Tehran, PO Box 6446-14155, Iran
City
Tehran
Postal code
Phone
+98 21 8895 4913
Fax
Email
f-jadidin@razi.tums.ac.ir; farhad_jadidi1986@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farhad Jadidi-Niaragh
Position
PhD student of Immunology
Other areas of specialty/work
Street address
Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Keshavarz boulevard, Tehran, PO Box 6446-14155, Iran
City
Tehran
Postal code
Phone
+98 21 8895 4913
Fax
Email
f-jadidin@razi.tums.ac.ir; farhad_jadidi1986@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farhad Jadidi-Niaragh
Position
PhD student of Immunology
Other areas of specialty/work
Street address
Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Keshavarz boulevard, Tehran, PO Box 6446-14155, Iran
City
Tehran
Postal code
Phone
+98 21 8895 4913
Fax
Email
f-jadidin@razi.tums.ac.ir; farhad_jadidi1986@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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