Protocol summary

Study aim
The purpose of this study is evaluate the effect of1to 4-week omega-3 consumption on muscle damage indices after eccentric resistance exercise
Design
A clinical trial with control group, with parallel group, triple-blinded and randomized on 60 subjects; using random number table for simple randomization
Settings and conduct
The study will be conducted at the Iran Football Medical Assessment and Rehabilitation Center (IFMARK).After receiving informed consent,participants will receive a nutritional questionnaire that records their diet for 12days, 3days a week, and then will be evaluated using NUTRITION4 software. After7days of the 1RM session ,supplementation will be begun. the subjects will be randomly divided into 6 groups of12 people The last supplement will be received8 hours before the eccentric resistance exercise. Before performing the exercise program, a blood sample test will be received from subjects to measure the levels of CK enzyme activity and LDH activity. The muscle pain perception will also be evaluated
Participants/Inclusion and exclusion criteria
Entery conditions:males with normal weight( 18/5<BMI<24/9).Exit condition: having a history of sports activities;taking dietary supplements,medication and painkillers;following a diet other than the general pattern of Iranian diet and following a special diet
Intervention groups
Intervention group1: 1week omega-3, 1200mg(EPA=720 and DHA=480),twice a day, for 1 week/ Intervention group2: 2 weeks omega-3, 1200mg(EPA=720 and DHA=480), twice a day, for 2 weeks/study group3: 3weeks omega-3, 1200 mg(EPA=720 and DHA=480), twice a day, for 3 weeks/Intervention group4: 4weeks omega-3,1200mg (EPA=720 and DHA=480), twice a day,for4 weeks/Control group1: sunflower oil capsules(placebo),1200mg, twice a day, for 4 weeks/ Control group2: without supplementation.
Main outcome variables
Serum creatine kinase enzyme; serum lactate dehydrogenase enzyme; muscle pain perception

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200327046871N2
Registration date: 2020-10-11, 1399/07/20
Registration timing: registered_while_recruiting

Last update: 2020-10-11, 1399/07/20
Update count: 0
Registration date
2020-10-11, 1399/07/20
Registrant information
Name
yasaman khazaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 0000 0000
Email address
khazaei.y@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of one to four-week omega-3 consumption on muscle damage indices after an eccentric exercise session
Public title
Effect of omega-3 on muscle damage indices
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Normal weight (18/5 < BMI < 24/9) Being male
Exclusion criteria:
Having a history of sports activities Taking dietary supplements, medication and painkillers Following a diet other than the general pattern of iranian diet Following a special diet
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The 60 subjects will be divided into six groups of ten using simple randomization method and by random number table. First, a list of all participants will be provided and the names from the list will be deleted. Then, using the random number table, the researcher will start from a random point and moves through the the row from left side, and assigns each selected number to each study group, randomly. This will continue until the number of people in each group is completed. Therefore, the researcher will not have the opportunity to change the status of the assignment of individuals or predict it.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The data analyst, outcome assessor, researcher and participants in the study do not know who is in the intervention groups and who is in the placebo group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Sport Sciences Research Institute
Street address
13th Floor, Block A, Center of the Ministry of Health, Treatment and Medical Education, Simai Iran St., between south Flamak and Zarafshan st., Qods Town.
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2020-09-14, 1399/06/24
Ethics committee reference number
IR.SSRC.REC.1399.066

Health conditions studied

1

Description of health condition studied
Muscle damage
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Serum keratin kinase enzyme activity
Timepoint
Before intervention, immediately, 24 hours, 48 ​​hours and 72 hours after intervention
Method of measurement
Level of enzyme activity by enzymatic colorimetric method

2

Description
Serum lactate dehydrogenase enzyme activity
Timepoint
Before intervention, immediately, 24 hours, 48 ​​hours and 72 hours after
Method of measurement
سطح فعالیت آنزیم از طریق روش رنگ سنجی آنزیمی

3

Description
pain perception
Timepoint
Before intervention, immediately, 24 hours, 48 ​​hours and 72 hours after
Method of measurement
Pain Assessment Scale(PAS)

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: omega-3, 1200 mg ( EPA=720 mg and DHA=480 mg), twice a day, for one week
Category
Prevention

2

Description
Second intervention group: omega-3, 1200 mg ( EPA=720 mg and DHA=480 mg), twice a day, for two weeks
Category
Prevention

3

Description
Third intervention group: omega-3, 1200 mg ( EPA=720 mg and DHA=480 mg), twice a day, for three weeks
Category
Prevention

4

Description
Fourth intervention group: omega-3, 1200 mg ( EPA=720 mg and DHA=480 mg), twice a day, for four weeks
Category
Prevention

5

Description
First Control group: sunflower oil capsules (as placebo), 1200 mg , twice a day, for four weeks
Category
Prevention

6

Description
Second control group: without supplementation
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran Football Medical Assessment and Rehabilitation Center (IFMARK)
Full name of responsible person
Foad Asjodi
Street address
IFMARK Medical Center, Iran National Football Center, above the Olympic Hotel, West boulevard of Azadi stadium
City
Tehran
Province
Tehran
Postal code
1484813111
Phone
+98 21 4473 8641
Email
info@ifmarc.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran Football Medical Assessment and Rehabilitation Center (IFMARK)
Full name of responsible person
Foad Asjodi
Street address
Ifmark Medical Center, Iran National Football Center, above the Olympic Hotel, West boulevard of Azadi stadium
City
Tehran
Province
Tehran
Postal code
1484813111
Phone
+98 21 4473 8641
Email
info@ifmarc.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran Football Medical Assessment and Rehabilitation Center (IFMARK)
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Yasaman KHazaei
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Next to Milad tower, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
y.khazaei97@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Yasaman KHazaei
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Next to Milad tower, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
y.khazaei97@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Yasaman Khazaei
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Next to Milad tower, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
y.khazaei97@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
no more informations
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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