Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001080415
Ethics application status
Approved
Date submitted
8/08/2016
Date registered
11/08/2016
Date last updated
11/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of tart cherry juice on recovery and next day performance in well-trained Water Polo players
Scientific title
Effect of tart cherry juice on recovery and next day performance in well-trained Water Polo players
Secondary ID [1] 289884 0
None
Universal Trial Number (UTN)
U1111-1186-1386
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oxidative Stress 299828 0
Inflammation 299829 0
Recovery and Next-Day Performance in Well-Trained Water Polo Athletes 299830 0
Condition category
Condition code
Musculoskeletal 299749 299749 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised repeated measures, cross-over design was utilised. All participants (n=9) were recruited from the Western Australian Institute of Sport (WAIS) Waterpolo (Men) Squad using the attached participant information sheets. A meeting was held with the head coach of WAIS Water Polo to discuss opportunities to disseminate the information sheet to potential participants. The information sheet was handed out at a training session. This information contained the lead investigators contact details, allowing potential participants to register their interest should they feel inclined.

Each experimental trial occured over 7 days. From day 1 to day 6, participants were supplemented with tart cherry juice or a placebo equivalent. During experimental weeks, all training (technical skills, weights, swimming) and recovery activities (cold water immersion) will be identical (between the cherry juice and placebo groups) and undertaken in a controlled environment. All testing sessions will also be performed in the morning to minimise any diurnal influence. Water-based performance testing included numerous tests (10 m sprint, water polo multi stage shuttle test, in water vertical jump and repeat sprint test) performed at the start (day 1) and at the end of each experimental trial (day 7). Finally, a 5-week washout period was adopted between the two experimental trials to preclude any follow-on effects,

On day 6, participants performed a simulated fatiguing team game activity, which has previously been reported to mimic the demands of a waterpolo match (Tan et al., 2010). The following morning (day 7), performance tests were repeated. Additionally, throughout the investigation various biological markers will also be measured (via venepuncture) to assess the efficacy of the cherry juice. Inflammatory markers (HS IL-6 and CRP) were measured on day 6 (pre- & post-exercise) and on day 7 (12 h post-exercise). Additionally, markers of oxidative stress (Uric Acid and F2-isoprostanes) were measured on day 1 and 6 (pre- & post-exercise), and again on day 7 (pre-exercise).

Participants consumed 90 mL daily of tart Montmorency CJ (Prunus Cerasus) concentrate (Cherry Active, Sunbury, UK) or a placebo equivalent for a total of 6 days. The cherry concentrate was diluted with water, such that each 30 mL serving was made up into a 200 mL beverage. Both the cherry juice and placebo were consumed in two doses each day; 200 mL before morning training, and 400 mL in the evening post-training. According to the manufacturer, a 30 mL dose of Cherry Active concentrate is equivalent to approximately 90 whole Montmorency tart cherries (Cherry Active, Sunbury, UK) containing 9.117 mg/mL of anthocyanins, which can have positive health and performance outcomes (Bell et al., 2014, Bowtell et al., 2011, Howatson at el., 2012).Daily adherence to supplement consumption was made by the investigators being present at every training session and obtaining empty bottle containers.

Bell, P.G., McHugh, M., Stevenson, E., & Howatson, G. (2014). The role of cherries in exercise and health. Scandinavian Journal of Medicine & Science in Sports, 24, 477-490.
Bowtell, J., Sumners, D., Dyer, A., Fox, P., & Mileva, K. (2011). Montmorency cherry juice reduces muscle damage caused by intensive strength exercise. Medicine & Science in Sports & Exercise, 43, 1544-1551.
Howatson, G., Bell, P.G., Tallent, J., Middleton, B., McHugh, M.P., & Ellis, J. (2012). Effect of tart cherry juice (prunus cerasus) on melatonin levels and enhanced sleep quality. European Journal of Nutrition, 51, 909-916.
Tan, F., Polglaze, T., Cox, G., Dawson, B., Mujika, I., & Clark, S. (2010). Effects of induced alkalosis on simulated match performance in elite female water polo players. International Journal of Sport Nutrition, 20, 198.
Intervention code [1] 295560 0
Lifestyle
Comparator / control treatment
This study adopted a randomised repeated measures, cross-over design. As such, participants performed both the cherry juice and placebo trial. The placebo was made by combining 40 mL of three different ‘off the shelf’ cordials. Lime (Woolworths select lime cordial, Australia), cranberry (Bickford’s cranberry juice cordial, Australia) and raspberry (Cottee’s raspberry flavoured cordial, Australia) cordials were mixed with food colouring and 480 mL of water in order to closely imitate the taste, colour and carbohydrate content (10 g/100 mL, maltodextrin powder, Nutricia Poly-Joule, Australia) without any of the anthocyanin content of the cherry juice.


Control group
Placebo

Outcomes
Primary outcome [1] 299208 0
Proportion of participants with a reduction in performance tests* decline when comparing the tart cherry juice and placebo trials

*Swimming-based tests comprised the 10 m sprint test, the repeat sprint test (RST), in-water vertical jump test (VJ), and the Water Polo Intermittent Shuttle Test (WIST) (Tan et al., 2009). All test protocols were conducted in accordance with the Australian National Water Polo Test Protocols (Tanner & Gore, 2013)

Tan F, Polglaze T, & Dawson B. Activity profiles and physical demands of elite women's water polo match play. J Sport Sci 2009; 27: 1095-1104.
Tanner RK, Gore CJ, & Australian Institute of Sport. Physiological tests for elite athletes. 2nd ed. Champaign, IL: Human Kinetics; 2013.
Timepoint [1] 299208 0
Day 7 Performance tests

*Swimming-based tests comprised the 10 m sprint test, the repeat sprint test (RST), in-water vertical jump test (VJ), and the Water Polo Intermittent Shuttle Test (WIST) (Tan et al., 2009). All test protocols were conducted in accordance with the Australian National Water
Primary outcome [2] 299209 0
Proportion of participants with reduced oxidative stress (F2-IsoP and uric acid) when comparing the tart cherry juice and placebo trials

Sample Analysis
The UA and F2-IsoP were assessed from blood samples. UA was measured using an Architect analyzer (ci8200), and determined using a UA Reagent (Abbott Diagnostics, Abbott Laboratories, Abbott Park, IL 60064, USA). F2-IsoP was analysed using an Agilent 6890 gas chromatograph coupled to an Agilent 5973 mass selective detector.
Timepoint [2] 299209 0
Day 6 post-exercise and Day 7 (12 h post-exercise)
Primary outcome [3] 299229 0
Proportion of participants with reduced inflammation (IL-6 and CRP) when comparing the tart cherry supplement and placebo trials

Sample Analysis
The IL-6 and CRP were assessed from blood samples. IL-6 was measured via immunoassay technique (Quantikine HS ELISA, R&D Systems, Inc. Minneapolis, USA). The CRP was measured using an Architect analyser (ci8200), and determined using a CRP Vario Reagent (SENTINEL CH. SpA, Via Robert Koch, 2, Milan 20152, Italy).
Timepoint [3] 299229 0
Day 6 post-exercise and Day 7 (12 h post-exercise)
Secondary outcome [1] 326510 0
Self-perceived delayed onset of muscle soreness (DOMS) ratings between the cherry juice and placebo trials.

DOMS was assessed using a numerical rating scale to measure how sore athletes felt, encompassing the anchor points of 0 (normal; without pain or stiffness) to 10 (very painful) (Hill & Richardson, 1989).

Hill DW, & Richardson JD. Effectiveness of 10% trolamine salicylate cream on muscular soreness induced by a reproducible program of weight training. J Orthop Sports Phys Ther 1989; 11: 19-23.
Timepoint [1] 326510 0
Day 7
Secondary outcome [2] 326568 0
Self-perceived quality of recovery, assessed using the total quality of recovery (TQR) scale between the cherry juice and placebo trials.

TQR was quantified using a numerical rating scale to determine how well athletes felt they had recovered, and encompassed the anchor points 6 (very, very poor recovery) to 20 (very, very good recovery) (Kentta & Hassmen, 1998).

Kentta G, & Hassmen P. Overtraining and recovery. Sports Med 1998; 26: 1-16.
Timepoint [2] 326568 0
Day 7

Eligibility
Key inclusion criteria
Well-trained Water Polo male athlete that are currently part of the Western Australian
Institute of sport daily training environment. All participants <18 years of age required parent/legal guardian consent prior to participating.
Minimum age
16 Years
Maximum age
30 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Injury and/or sickness

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed to participants and the principal researcher via numbered containers to which trial (cherry juice or placebo) the participant was allocated to during the experimental weeks.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book was adopted for this process.
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
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Ten elite male waterpolo players will be recruited from the Western Australian Institute of Sport Waterpolo Squad. This sample size (n=10; F=2.14; expected power=0.85; a=p<0.05) was determined using a power analysis (G*power Version 3.1.9.2, Bonn University, Bonn, Germany) based on inflammatory responses under the influence of tart cherry juice (Howatson et al., 2009). Howatson et al., (2009) Scan J Med Sci Sports. 20(6), 843-852.

Results are expressed at mean (+/-SD) and were analysed using a repeated measures analysis of variance (ANOVA) to determine time, condition and interaction effects of tart cherry juice on measures of perceptual recovery (TQR and DOMS), blood variables (UA, F2-IsoP, IL-6 and CRP) and performance. A post-hoc paired samples t-test was used to determine any differences between trials. The alpha level was accepted at p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/05/2015
Date of last participant enrolment
Anticipated
Actual
30/05/2015
Date of last data collection
Anticipated
23/08/2015
Actual
30/08/2015
Sample size
Target
10
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 13976 0
6010 - Mount Claremont

Funding & Sponsors
Funding source category [1] 294253 0
Government body
Name [1] 294253 0
Australian Institute of Sport, Australian Sports Comission
Country [1] 294253 0
Australia
Primary sponsor type
Government body
Name
Western Australian Institute of Sport
Address
WAIS High Performance Service Centre
McGillivray Road
Mt Claremont, WA 6010
Country
Australia
Secondary sponsor category [1] 293085 0
University
Name [1] 293085 0
The University of Western australia
Address [1] 293085 0
35 Stirling Hwy, Crawley WA 6009
Country [1] 293085 0
Australia
Other collaborator category [1] 279154 0
University
Name [1] 279154 0
Federation University Australia
Address [1] 279154 0
University Dr, Mount Helen VIC 3350
Country [1] 279154 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295675 0
The University of Western Australia Human Ethics Committee
Ethics committee address [1] 295675 0
Ethics committee country [1] 295675 0
Australia
Date submitted for ethics approval [1] 295675 0
02/03/2015
Approval date [1] 295675 0
14/04/2015
Ethics approval number [1] 295675 0
RA/4/1/7380

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1000 1000 0 0
/AnzctrAttachments/371259-Application Approval.pdf
Attachments [2] 1003 1003 0 0
/AnzctrAttachments/371259-Research Study Info and Consent Form C4.pdf

Contacts
Principal investigator
Name 68094 0
Dr Marc Sim
Address 68094 0
Federation University Australia
University Dr, Mount Helen VIC 3350
Country 68094 0
Australia
Phone 68094 0
+61353279004
Fax 68094 0
Email 68094 0
[email protected]
Contact person for public queries
Name 68095 0
Marc Sim
Address 68095 0
Federation University Australia
University Dr, Mount Helen VIC 3350
Country 68095 0
Australia
Phone 68095 0
+61353279004
Fax 68095 0
Email 68095 0
[email protected]
Contact person for scientific queries
Name 68096 0
Marc Sim
Address 68096 0
Federation University Australia
University Dr, Mount Helen VIC 3350
Country 68096 0
Australia
Phone 68096 0
+61353279004
Fax 68096 0
Email 68096 0
[email protected]

No information has been provided regarding IPD availability


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
Dimensions AIEffect of tart cherry juice on recovery and next day performance in well-trained Water Polo players2016https://doi.org/10.1186/s12970-016-0151-x
N.B. These documents automatically identified may not have been verified by the study sponsor.