Protocol summary

Study aim
Effect of Curcumin supplementation on muscle damage, antioxidant status and inflammatory factors after the taekwondo race
Design
The study was a phase 2, community-based and pragmatic, randomized, single blind, controlled clinical trial on 18 subjects, and a sealed envelope was used for randomization.
Settings and conduct
All subjects took part in a legal taekwondo race (3 competitions) in the gymnasium hall of Tabriz University three days after taking the supplement. One-way blinding was used. The method of blinding was that all capsules (curcumin and placebo) were similar in color (white) and size (1 g) and were coded and none of the subjects knew the contents of the capsules until the end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all subjects must have had at least 3 years of experience in Taekwondo competitions; Non-inclusion criteria: Athletes' maximum oxygen consumption (VO2 max) should not be less than 45 precent
Intervention groups
Intervention group: 9 male taekwondo players who took curcumin supplements and participated in 3 taekwondo competitions (curcumin group). Control group: 9 male taekwondo players who consumed rice powder and participated in 3 taekwondo competitions (Placebo group).
Main outcome variables
Creatine kinase (CK); lactate dehydrogenase (LDH); malonyl dialdehyde (MDA); total antioxidant capacity (TAC); interleukin- 6 (IL-6)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180513039637N3
Registration date: 2020-05-24, 1399/03/04
Registration timing: retrospective

Last update: 2020-05-24, 1399/03/04
Update count: 0
Registration date
2020-05-24, 1399/03/04
Registrant information
Name
Hadi Pourmanaf
Name of organization / entity
Tehran University
Country
Iran (Islamic Republic of)
Phone
+98 41 3656 1262
Email address
hadi.pvrmnaf@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-01, 1397/02/11
Expected recruitment end date
2018-05-08, 1397/02/18
Actual recruitment start date
2018-05-01, 1397/02/11
Actual recruitment end date
2018-05-08, 1397/02/18
Trial completion date
2018-05-08, 1397/02/18
Scientific title
Effects of curcumin supplementation in comparison with placebo on serum creatinine kinase (CK), lactate dehydrogenase (LDH), malonyl dialdehyde (MDA), total antioxidant capacity (TAC), and interleukin-6 (IL-6) after taekwondo race in taekwondo men
Public title
Effect of Curcumin supplementation on muscle damage
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
At least 3 years of experience in taekwondo competitions Athletes' maximum oxygen consumption (VO2 max) should be more than 45 percent
Exclusion criteria:
Having a history of diabetes Having a history of cardiovascular disease Having a history of respiratory disease Having food allergies Having a drug allergy Use of inflammatory agents before or during the study Use a sports supplement before or during the study Use the drug before or during the study
Age
From 19 years old to 27 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 19
Actual sample size reached: 18
Randomization (investigator's opinion)
Randomized
Randomization description
Using simple randomization, individuals were divided into two homogeneous groups (curcumin and placebo). Randomization tools were also sealed envelopes. The randomization unit was also individual. The odd numbers in the envelope showed the subjects in the curcumin group, and the even numbers showed the subjects in the placebo group. The allocation concealment was such that none of the subjects knew the meaning of the numbers in the envelope and did not know which group they belonged to.
Blinding (investigator's opinion)
Single blinded
Blinding description
The capsules were identical in weight (1 g, 0.5 g), form, color and packing. They were coded and No subjects were aware of the contents of the capsules until the end of the study.
Placebo
Used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Sport Science Research Institute
Street address
No.3, 5th closed alley, Miremad street., Qods Town
City
Tehran
Province
Tehran
Postal code
00000-00000
Approval date
2020-04-12, 1399/01/24
Ethics committee reference number
IR.SSRC.REC.1399.015

Health conditions studied

1

Description of health condition studied
Dose not apply
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Serum creatine kinase (CK) level in taekwondo athletes
Timepoint
Blood sampling was performed before the start of supplementation (3 day before the race), one hour before the race, immediately after the race, 24 hours and 48 hours after the race (5 stages).
Method of measurement
Creatine kinase kit

2

Description
Serum lactate dehydrogenase (LDH) level in taekwondo athletes
Timepoint
Blood sampling was performed before the start of supplementation (3 day before the race), one hour before the race, immediately after the race, 24 hours and 48 hours after the race (5 stages).
Method of measurement
lactate dehydrogenase kit

3

Description
Serum Malonyl Dialdehyde (MDA) Levels in Taekwondo Athletes
Timepoint
Blood sampling was performed before the start of supplementation (3 day before the race), one hour before the race, immediately after the race, 24 hours and 48 hours after the race (5 stages).
Method of measurement
Malonyl Dialdehyde kit

4

Description
Serum total antioxidant capacity (TAC) levels in Taekwondo athletes
Timepoint
Blood sampling was performed before the start of supplementation (3 day before the race), one hour before the race, immediately after the race, 24 hours and 48 hours after the race (5 stages).
Method of measurement
total antioxidant capacity kit

5

Description
Serum Interleukin-6 (IL-6) Level in Taekwondo Athletes
Timepoint
Blood sampling was performed before the start of supplementation (3 day before the race), one hour before the race, immediately after the race, 24 hours and 48 hours after the race (5 stages).
Method of measurement
Interleukin-6 kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 9 male Taekwondoers who took curcumin supplements (4 g/d) for 5 days. 3 days after eating curcumin, subjects participated in Taekwondo competition (3 races with 30 min rest) and received curcumin for up to two days after the competition. In this study, the curcumin supplement produced by Karma Company, Iran was used.
Category
Other

2

Description
Control group: 9 male Taekwondoers who took placebo supplements (4 g/d of rice flour) for 5 days. 3 days after eating placebo, subjects participated in Taekwondo competition (3 races with 30 min rest) and received placebo for up to two days after the competition.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital in Tabriz
Full name of responsible person
Aytak memarzadeh
Street address
Shafa alley, Azadi boulevard
City
Tabriz
Province
East Azarbaijan
Postal code
00000-00000
Phone
+98 41 3667 3861
Email
Aytak_memarzadeh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farzad Zehsaz
Street address
Pasdaran highway - Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
00000-00000
Phone
+98 41 3667 3861
Email
f-zehsaz@iaut.ac.ir
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
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
Tabriz University of Medical Sciences
Full name of responsible person
Hadi Pourmanaf
Position
Master Educated
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 497, Banafsheh alley, Valliamr boulevard
City
Tabriz
Province
East Azarbaijan
Postal code
00000-00000
Phone
+98 41 3667 3861
Fax
Email
hadi.pvrmnaf@ut.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leila Nikniaz
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. Azadi Alvd., Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
00000-00000
Phone
+98 41 3667 3861
Email
Nikniazleila@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hadi Pourmanaf
Position
Master Educated
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 497, Banafsheh alley, Valliamr boulevard
City
Tabriz
Province
East Azarbaijan
Postal code
00000-00000
Phone
+98 41 3667 3861
Fax
Email
hadi.pvrmnaf@ut.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
In adress: Sportdezh.rzb.ir
When the data will become available and for how long
Every time
To whom data/document is available
everyone
Under which criteria data/document could be used
Modeling of the subject, supplementation method and training method is allowed
From where data/document is obtainable
Send an email to hadipourmanaf@yahoo.com or visit Sportdezh.rzb.ir.
What processes are involved for a request to access data/document
Send an email to hadipourmanaf@yahoo.com or visit Sportdezh.rzb.ir.
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