The effect of Spirulina supplementation on plasma markers of exercise-induced muscle damage, IL-6 and antioxidant capacity in Tekwando athletes: a cross-over trail.
Determining the effect of Spirulina supplementation on plasma markers of exercise-induced muscle damage, interleukin 6 and antioxidant capacity in taekwondo athletes
Design
This clinical trial was a double-blind, placebo-controlled crossover trial. The study had two periods separated by a 14-day washout.
Settings and conduct
This study is about nutritional recovery in taekwondo athletes.The study is conducted at the Taekwondo House in Tehran. The study has 2 courses and 4 days of exercise testing and blood sampling. Group 1 receives spirulina in the first period and placebo in the second period and group 2 receive placebo in the first period and spirulina in the second period. The study had two periods separated by a 14-day washout. Double-blinding is performed for the subjects and researchers. Packing, color and smell of the supplement and placebo are similar and blinding is done with the coding.
Participants/Inclusion and exclusion criteria
Teakwondo athletes;
3 years of experience in Taekwondo;
Age from 18 to 35 years
Intervention groups
Receive 8 grams of spirulina sachet or 8 grams of starch flour colored with the allowed food coloring and similar essential oil for 21 days. Due to being crossover, both groups will receive a supplement and a placebo in one of the courses
Main outcome variables
Plasma indicators of exercise-induced muscle damage; antioxidant and inflammatory indicators
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121110011421N4
Registration date:2021-07-12, 1400/04/21
Registration timing:retrospective
Last update:2021-07-12, 1400/04/21
Update count:0
Registration date
2021-07-12, 1400/04/21
Registrant information
Name
Kurosh Djafarian
Name of organization / entity
TUMS
Country
Iran (Islamic Republic of)
Phone
+98 88973901
Email address
kdjafarian@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-09, 1398/01/20
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
2019-05-10, 1398/02/20
Actual recruitment end date
2019-10-23, 1398/08/01
Trial completion date
2019-11-01, 1398/08/10
Scientific title
The effect of Spirulina supplementation on plasma markers of exercise-induced muscle damage, IL-6 and antioxidant capacity in Tekwando athletes: a cross-over trail.
Public title
The effect of Spirulina supplementation on plasma markers of exercise-induced muscle damage
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Male Taekwondo Athletes
Taekwondo athletes with experience of at least 3 years
Age from 18 to 35 years
Exclusion criteria:
Tobacco and drug use in the last year
Use of anti-inflammatory drugs in the last three months
Follow special and unusual diets in the last three months
Consumers of sports supplements in the last three months
Having chronic diseases that require a person to take medicine
People weighing less than 40 kg
Blood donors during the month before the test
People with illness or surgery in the last 3 months
Age
From 18 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
18
Actual sample size reached:
18
Randomization (investigator's opinion)
Randomized
Randomization description
To create random sequences in this study which has two groups, the coin toss method was used. The first group includes people who first receive spirulina and then placebo, and the second group receives first placebo and then spirulina. Coin toss was performed according to the sample size and individuals were randomly assigned to one of the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Supplement and placebo delivered to the two groups are completely similar in appearance and the researcher will be aware of its coding at the end of the study.
Placebo
Used
Assignment
Crossover
Other design features
The study is designed as a crossover. The study has two periods with a duration of 21 days. In the first period, group 1 receives spirulina and in the second period receives a placebo. Group 2 receives placebo in the first period and spirulina in the second period. The two study periods are separated by a 14-day washout period.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Ghods street., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
00982181633610
Approval date
2017-09-13, 1396/06/22
Ethics committee reference number
IR.TUMS.VCR.REC.1396.3464
Health conditions studied
1
Description of health condition studied
Exercise-induced muscle damage
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Plasma levels of the lactate dehydrogenase enzyme (muscle damage Index)
Timepoint
Day 1 after exercise and day 22 after exercise, after a 14-day washout period, again day 1 after exercise and day 22 after exercise (4 time in total)
Method of measurement
Elaisa test
2
Description
Plasma levels of the creatine kinase enzyme (muscle damage Index)
Timepoint
Day 1 after exercise and day 22 after exercise, after a 14-day washout period, again day 1 after exercise and day 22 after exercise (4 time in total)
Method of measurement
Elaisa test
3
Description
Plasma levels of Interleukin 6
Timepoint
Day 1 after exercise and day 22 after exercise, after a 14-day washout period, again day 1 after exercise and day 22 after exercise (4 time in total)
Method of measurement
IL 6 kit
4
Description
Total antioxidant capacity (TAC)
Timepoint
Day 1 after exercise and day 22 after exercise, after a 14-day washout period, again day 1 after exercise and day 22 after exercise (4 time in total)
Method of measurement
Total antioxidant assay kit
5
Description
Activity of Super oxide dismutase enzyme (SOD)
Timepoint
Day 1 after exercise and day 22 after exercise, after a 14-day washout period, again day 1 after exercise and day 22 after exercise (4 time in total)
Method of measurement
Super oxide dismutase assay kit
6
Description
Glutathione peroxidase enzyme activity
Timepoint
Day 1 after exercise and day 22 after exercise, after a 14-day washout period, again day 1 after exercise and day 22 after exercise (4 time in total)
Method of measurement
Glutathione peroxidase assay kit
7
Description
Plasma level of malondialdehyde
Timepoint
Day 1 after exercise and day 22 after exercise, after a 14-day washout period, again day 1 after exercise and day 22 after exercise (4 time in total)
Method of measurement
Malondialdeyde assay kit
Secondary outcomes
1
Description
Weight
Timepoint
Day 1 after exercise and day 22 after exercise, after a 14-day washout period, again day 1 after exercise and day 22 after exercise (4 time in total)
Method of measurement
Seca Scale
Intervention groups
1
Description
This study has two groups. Group 1 receives spirulina in the first period of study and placebo in the second period of study. Group 2 receive placebo in the first period and spirulina in the second period. The two study periods are separated by a 14-day washout period. The duration of receiving spirulina or placebo in the first and second period is 21 days.The spirulina sachet contained 8 g of Spirulina flavored with lemon and mint (Qeshm Island Science and Technology Park by Drotat Setareh Qeshm). The placebo sachet was 8 g starch flour with the same flavor and green food coloring.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian tekvando center
Full name of responsible person
Dr mohammad hozoori
Street address
Tehran Azadi complex
City
Tehran
Province
Tehran
Postal code
1931735593
Phone
+98 21 2224 2441
Email
mhozoori@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr mohamadali sahraeyan
Street address
Keshavarz Boulevard; Corner of Quds Street; University Central Building; Class Six
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 7381
Fax
+98 21 8898 9664
Email
resdputy@tums.ac.ir
Web page address
Grant name
Vice Chancellor for Research, Tehran University of Medical Sciences
Grant code / Reference number
96-01-161-34860
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arvin kashani
Position
Phd student in nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Vesk Ave., 14 street number 31
City
Tehran
Province
Tehran
Postal code
4545656456
Phone
+98 21 4436 6496
Email
kashani.arvin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kurosh djafarian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Vesal shirazi Ave., SNSD
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 4837
Email
kdjafarian@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arvin kashani
Position
Phd student in nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Vesk Ave., 14 steert number 31
City
Tehran
Province
Tehran
Postal code
4545656456
Phone
+98 21 4436 6496
Email
kashani.arvin@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
According to the field of study and information received from people, all parts of it have the ability to share data
When the data will become available and for how long
Access from the second half of 1400
To whom data/document is available
All researchers in the field of sport nutrition
Under which criteria data/document could be used
All data obtained can be used for various analyzes
From where data/document is obtainable
The request should be sent to the e-mail of Dr. Kurosh Djafarian or Arvin Kashani.
kdjafarian@tums.ac.ir
kashani.arvin@gmail.com
What processes are involved for a request to access data/document
After receiving the application and reviewing it by email, it will be sent to the people within 2 working weeks.