Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001131549
Ethics application status
Approved
Date submitted
26/08/2024
Date registered
19/09/2024
Date last updated
19/09/2024
Date data sharing statement initially provided
19/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of acute curcumin supplementation on recovery from a match-play simulation in team-sport athletes.
Scientific title
Effect of acute curcumin supplementation on recovery from a match-play simulation in team-sport athletes.
Secondary ID [1] 312806 0
Nil
Universal Trial Number (UTN)
U1111-1312-3735
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle damage 334872 0
Recovery 334873 0
Condition category
Condition code
Physical Medicine / Rehabilitation 331425 331425 0 0
Other physical medicine / rehabilitation
Alternative and Complementary Medicine 331426 331426 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study examines the effects of acute curcumin supplementation in team sport athletes, using a randomised, cross-over, repeated-measure, placebo-controlled, double blind design. Participants will consume two capsules daily of either curcumin (Curcumin Gold with LipiSperse technology vy Natures Help, each containing 396 mg of curcumin) or a placebo for five consecutive days. After completing the supplement phase, participants will undergo a seven-day washout period before starting the second round of supplementation.
Prior to supplementation, participants will undergo a baseline testing session (approximately 90 minutes) that includes a series of field tests (countermovement jump, repeated sprints, Yo-Yo fitness test). Once baseline testing is complete, participants will be randomly assigned to begin their first supplementation.
The supplementation timeline and requirements for curcumin and placebo will be identical. Participants will start taking their assigned supplement two days before a match-play simulation (approximately 120 minutes including warm-up). The match-play simulation is a circuit designed to elicit physiological changes similar to team sport matches. The circuit will incorporate repeated sprints, agility, deceleration and walking. Post match-play simulation, the participants will continue to take the supplement for a further two days. Afterward, they will return to perform the same battery off tests conducted during the baseline sessions.
All sessions will be run and supervised by an exercise scientist. Adherence to the intervention will be assessed by the return of the pill boxes. Each participant will be provided a pill box with the correct amount of supplementation required for the duration of the testing.
Intervention code [1] 329348 0
Treatment: Other
Comparator / control treatment
Participants received an oblique capsule containing either curcumin or the placebo. The placebo capsule contained 48.5g of glucose (Glucodin Pure Glucose Energy, Glucodin).
Control group
Placebo

Outcomes
Primary outcome [1] 339187 0
Recovery
Timepoint [1] 339187 0
Baseline, immediately post, 24 hours & 48 hours post match play simulation for each condition.
Secondary outcome [1] 438978 0
Creatine Kinase
Timepoint [1] 438978 0
Baseline, 24 & 48 hours post match play simulation simulation for each condition.
Secondary outcome [2] 438979 0
Countermovement Jump Performance
Timepoint [2] 438979 0
Baseline, 48 hours post match play simulation for each condition.
Secondary outcome [3] 439397 0
Repeated sprint ability
Timepoint [3] 439397 0
Baseline and 48 hours post match-play simulation for each condition.
Secondary outcome [4] 439398 0
Endurance performance
Timepoint [4] 439398 0
Baseline and 48 hours post match-play simulation for each condition.

Eligibility
Key inclusion criteria
The inclusion criteria is:
- team sport athletes from soccer, Australian Rules football, field hockey and rugby.
- training a minimum twice a week and recently been competing in a team sport environment.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants are excluded if they:
- have been regularly consuming nonsteroidal anti-inflammatory drugs (NSAIDs).
- Have any current inflamed injuries or past injuries that may limit performance.
- Are currently (or in the last three months) taking any supplementation containing curcumin or any other anti-inflammatory/antioxidant ingredients.
- Currently have or have had liver problems or any other health conditions that may impact exercise.

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)
Participants will not know the order of supplement consumption. Allocation of the order will be completed by the chief investigator, capsule boxes will be handed over to the researcher labelled either block 1 or block 2. All supplements will be within oblique capsules. The researcher will not know what supplements are in which container.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation (coin toss) will be used to decide which condition the participant will complete first,
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 18 has a 90% power to detect a standardised mean difference of 0.41 based on previous research considering countermovement jump as the primary outcome post-supplementation (Foskett et al., 2009). Therefore we will recruit 20 participants to account for any missing data and dropouts whilst still achieving power.
A two-way repeated-measures analysis of variance (ANOVA) will be used to assess the difference in exercise performance, recovery, and blood measures. Data will be expressed as means + standard deviation (SD), unless stated otherwise, with statistical significance set at p < 0.05. In addition, Cohen's d effect size (ES) will be calculated to assess the magnitude of any differences. Classification of ES: >0.8 large, 0.5-0.79 moderate, and < 0.49 small effect (Cohen, 1988). Data anaylsis will be performed using R.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/07/2024
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
28/04/2025
Actual
Sample size
Target
20
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317240 0
University
Name [1] 317240 0
Curtin University
Country [1] 317240 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Country
Australia
Secondary sponsor category [1] 319526 0
None
Name [1] 319526 0
Address [1] 319526 0
Country [1] 319526 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315978 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 315978 0
Ethics committee country [1] 315978 0
Australia
Date submitted for ethics approval [1] 315978 0
08/12/2023
Approval date [1] 315978 0
29/02/2024
Ethics approval number [1] 315978 0
HRE2024-0080

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

Contacts
Principal investigator
Name 136406 0
Miss Larissa Walsh
Address 136406 0
Curtin University, GPO Box U1987, Kent Street, Bentley, Western Australia, 6102
Country 136406 0
Australia
Phone 136406 0
+61 417625990
Fax 136406 0
Email 136406 0
larissa.walsh@postgrad.curtin.edu.au
Contact person for public queries
Name 136407 0
Larissa Walsh
Address 136407 0
Curtin University, GPO Box U1987, Kent Street, Bentley, Western Australia, 6102
Country 136407 0
Australia
Phone 136407 0
+61 417625990
Fax 136407 0
Email 136407 0
larissa.walsh@postgrad.curtin.edu.au
Contact person for scientific queries
Name 136408 0
Kagan Ducker
Address 136408 0
Curtin University, GPO Box U1987, Kent Street, Bentley, Western Australia, 6102
Country 136408 0
Australia
Phone 136408 0
+61419924263
Fax 136408 0
Email 136408 0
kagan.ducker@curtin.edu.au

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
No additional documents have been identified.