Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000456752
Ethics application status
Approved
Date submitted
5/02/2022
Date registered
23/03/2022
Date last updated
23/03/2022
Date data sharing statement initially provided
23/03/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of curcumin supplementation on prooxidant/antioxidant balance, inflammation and exercise-induced muscle damage in physically active men.
Scientific title
The effect of curcumin supplementation on prooxidant/antioxidant balance, inflammation and exercise-induced muscle damage in physically active men (long distance amateur runners).
Secondary ID [1] 306337 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oxidative stress 325125 0
Inflammation 325126 0
Muscle damage 325127 0
Condition category
Condition code
Inflammatory and Immune System 322532 322532 0 0
Normal development and function of the immune system
Blood 322533 322533 0 0
Normal development and function of platelets and erythrocytes
Alternative and Complementary Medicine 322534 322534 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is controlled, double-blind, parallel intervention trial in healthy men (amateur long distance runners). The purpose of this intervention is to evaluate the effects of 2 g curcumin supplementation on prooxidant/antioxidant balance, inflammation and exercise-induced muscle damage. The participants will take 2 capsules (500 mg each) of curcumin extract with piperine (Curcumin 500 max, Nanga, Zlotów, Poland) twice a day before meals, i.e. before breakfast and before dinner, drinking water, for a period of 6 weeks. According to the manufacturer's information, the content of the supplement capsule consists of: extract from long spurge standardised to 95% curcumin (500 mg) and extract from black pepper 95% (10 mg), an ingredient of the capsule (gelatin, purified water 13-17%).
The study will be conducted in two phases:
- in the first phase all subjects and will undergo assessment of body composition. Then all subjects will perform a running test with gradually increasing load on a moving treadmill. Blood for biochemical tests will be collected 3 times, i.e., before the start of the exercise test, 3-5 minutes after its completion and at 1 hour post-exercise restitution. The subjects will then be randomly divided into two groups: curcumin supplemented and placebo.
-in the second phase of the study (6 weeks after starting the supplement or placebo), the subjects will again undergo assessment of baseline body composition and perform a running test as above. Blood for biochemical tests will be collected 3 times, i.e., before the start of the exercise test, 3-5 minutes after its completion and at 1 hour post-exercise restitution.
Intervention code [1] 322768 0
Treatment: Other
Comparator / control treatment
The placebo group participants received identical capsules but containing corn-starch (400 mg) and riboflavin pigment (10 mg). The dose of placebo was the same as when using the supplement.
Control group
Placebo

Outcomes
Primary outcome [1] 330325 0
The body composition of the participants will be assessed by the bioimpedance method.
Timepoint [1] 330325 0
Baseline, 6 weeks post-commencement of intervention.
Primary outcome [2] 330329 0
Individual VO2max will be determined by having
participants perform an incremental treadmill running test (a Cosmed treadmill, Germany).
Timepoint [2] 330329 0
After completion of anthropometric measurements at baseline, 6 weeks post-commencement of intervention.
Secondary outcome [1] 405851 0
Assessment of muscle damage markers activity (CK, LDH) in blood plasma at rest, immediately after exercise, in 1h of restitution in each study phase (1 and 2) with using by the spectrophotometric methods.
Timepoint [1] 405851 0
After blood seperation, on the same day as blood collection at baseline and 6 weeks post-commencement of intervention.
Secondary outcome [2] 405852 0
Assessment of blood morphology using blood smear on the same day in each study phase (1 and 2) in external laboratory.
Timepoint [2] 405852 0
The biochemical tests will be performed after the collection of material at baseline and 6 weeks post-commencement of intervention.
Secondary outcome [3] 405853 0
Changes in markers of antioxidant status (SOD, CAT, GPx, GSH, UA, TAS) at rest, immediately after exercise, in 1h of restitution in each study phase (1 and 2). SOD, CAT, GPX will be analysed using spectrophotometric methods in erythrocythes. GSH will be measured in whole blood and UA in plasma samples using spectrophotometric method. TAS will be measured by a colorimetric method in blood serum.
Timepoint [3] 405853 0
Baseline and 6 weeks post-commencement of intervention. The biochemical tests will be performed after the end of the program.
Secondary outcome [4] 405854 0
Changes in inflammatory markers (TNF-alpha, CRP, IL-1ß, IL-6) in blood serum at rest, immediately after exercise, in 1h of restitution in each study phase (1 and 2) with using by the immunoenzymatic methods, excluding CRP which was measured by spectrophotometric method in an external laboratory.
Timepoint [4] 405854 0
Baseline and 6 weeks post-commencement of intervention. The biochemical tests will be performed after the end of the program.
Secondary outcome [5] 406439 0
Assesment of Sirtuin 3 level in blood serum at rest, immediately after exercise, in 1h of restitution in each study phase (1 and 2) with using by the immunoenzymatic methods.
Timepoint [5] 406439 0
Baseline and 6 weeks post-commencement of intervention. The biochemical tests will be performed after the end of the program.
Secondary outcome [6] 406440 0
Changes in myoglobin concentration in blood serum at rest, immediately after exercise, in 1h of restitution in each study phase (1 and 2) with using by the immunoenzymatic methods.
Timepoint [6] 406440 0
Baseline and 6 weeks post-commencement of intervention. The biochemical tests will be performed after the end of the program.
Secondary outcome [7] 406443 0
Changes in aminotransferases (ALT, AST) concentration in blood serum at rest, immediately after exercise, in 1h of restitution in each study phase (1 and 2) with using by the spectrophotometric methods in external laboratory.
Timepoint [7] 406443 0
Baseline and 6 weeks post-commencement of intervention. The biochemical tests will be performed after the end of the program.
Secondary outcome [8] 406444 0
Changes in markers of oxidative stress ( 8-OHdG, MDA) concentration at rest, immediately after exercise, in 1h of restitution in each study phase (1 and 2) . The plasma malondialdehyde (MDA) concentration was determined by means of the thiobarbituric acid (TBARS) reaction. 8-OHdG will be measured in serum samples using immunoenzymathic method.
Timepoint [8] 406444 0
Baseline and 6 weeks post-commencement of intervention. The biochemical tests will be performed after the end of the program.

Eligibility
Key inclusion criteria
Inclusion criteria were healthy male and training experience of three years minimum.
Minimum age
20 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria included the use of tobacco products, alcohol consumption, any medicines or dietary supplements in the four previous weeks.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Volunteers are randomly assigned to the groups. Allocation of the participants will be conceal using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated simple randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The statistical analysis was performed in IBM Statistics 26.0 (IBM Corporation, Ar-monk, NY, USA).

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
18/11/2019
Date of last participant enrolment
Anticipated
Actual
13/12/2019
Date of last data collection
Anticipated
Actual
12/02/2020
Sample size
Target
60
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 24537 0
Poland
State/province [1] 24537 0
Silesia Poland

Funding & Sponsors
Funding source category [1] 310689 0
University
Name [1] 310689 0
University of Physical Education in Katowice
Country [1] 310689 0
Poland
Primary sponsor type
University
Name
University of Physical Education in Katowice
Address
40-065 Katowice, Mikolowska 72A
Poland
Country
Poland
Secondary sponsor category [1] 311910 0
Individual
Name [1] 311910 0
dr Ewa Sadowska-Krepa PhD
Address [1] 311910 0
University of Physical Education in Katowice,
40-065 Katowice, Mikolowska 72A
Poland
Country [1] 311910 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310273 0
University Bioethics Committee for Scientific Research at the Academy of Physical Education in Katowice
Ethics committee address [1] 310273 0
Ethics committee country [1] 310273 0
Poland
Date submitted for ethics approval [1] 310273 0
31/07/2019
Approval date [1] 310273 0
14/11/2019
Ethics approval number [1] 310273 0
Certificate no. 11/2019.

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117086 0
Mr Sebastian Bankowski
Address 117086 0
University of Physical Education in Katowice,
40-065 Katowice, Mikolowska 72A,
Poland
Country 117086 0
Poland
Phone 117086 0
+48 32 207 51 54
Fax 117086 0
Email 117086 0
[email protected]
Contact person for public queries
Name 117087 0
Sebastian Bankowski
Address 117087 0
University of Physical Education in Katowice,
40-065 Katowice, Mikolowska 72A,
Poland
Country 117087 0
Poland
Phone 117087 0
+48 32 207 51 54
Fax 117087 0
Email 117087 0
[email protected]
Contact person for scientific queries
Name 117088 0
Ewa Sadowska-Krepa
Address 117088 0
University of Physical Education in Katowice,
40-065 Katowice, Mikolowska 72A,
Poland
Country 117088 0
Poland
Phone 117088 0
+48 32 207 51 47
Fax 117088 0
Email 117088 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of 6-week curcumin supplementation on aerobic capacity, antioxidant status and sirtuin 3 level in middle-aged amateur long-distance runners.2022https://dx.doi.org/10.1080/13510002.2022.2123882
N.B. These documents automatically identified may not have been verified by the study sponsor.