Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000765426
Ethics application status
Approved
Date submitted
8/06/2016
Date registered
10/06/2016
Date last updated
8/10/2021
Date data sharing statement initially provided
8/10/2021
Date results information initially provided
8/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of cherry consumption on acute exercise-induced inflammation in well-trained cyclists.
Scientific title
The impact of sweet cherry consumption on acute inflammation following high-intensity exercise in trained cyclists - a randomised, double-blind, placebo-controlled, crossover study.
Secondary ID [1] 289382 0
Nil known
Universal Trial Number (UTN)
U1111-1183-9969
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise-induced inflammation 299027 0
Condition category
Condition code
Alternative and Complementary Medicine 299082 299082 0 0
Other alternative and complementary medicine
Inflammatory and Immune System 299083 299083 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants were asked to refrain from ingesting dietary anthocyanins or flavonoids and were provided with a food and exercise plan and diary to complete in the week prior to both the familiarisation and trial sessions. Participants underwent an initial familiarisation session, at which time baseline blood samples were taken. Participants completed a ramp incremental VO2max test to ascertain their level of cardiovascular fitness. Lactate and blood glucose measurements were taken every 2 minutes via finger prick. Participants with a VO2max of between 4.5 and 5.0L/min were included in the supplementation and trial sessions. Participants were given cherry drinks containing cherries, water and lemon juice (at a 10:5:1 ratio) with an anthocyanin content of 540mg/drink, or carbohydrate-matched, blended pear drinks containing 0mg anthocyanin (placebo). One drink was consumed each day for the 3 days prior to the trial, with a final drink consumed 1 hour immediately prior to the commencement of the trial. To monitor adherence to the intervention, drinks were provided in opaque bottles which were returned the day following provision. The cycling trial consisted of 60second intervals of cycling on a cycle ergometer at a workload equivalent to 100%VO2max followed by 75 seconds of active recovery at 50%VO2max, until the 100%VO2max workload was unable to be maintained. A 10 minute warm-up and cool-down at 50%VO2max was undertaken prior to and following the trial. Lactate and blood glucose measurements were taken in each active recovery phase via finger prick. Venous blood samples were collected immediately following exercise and at 24 hours post exercise. At 24 hours post exercise, participants indicated perceived muscle soreness via a 10 cm visual analog scale. Following a washout period of at least two weeks, participant groups crossed over and the supplementation and cycling trial was repeated.
Intervention code [1] 294971 0
Treatment: Other
Intervention code [2] 294994 0
Prevention
Comparator / control treatment
Placebo - carbohydrate-matched, blended pear drink (containing 0% anthocyanins)
Control group
Placebo

Outcomes
Primary outcome [1] 298563 0
Changes in plasma IL-6 concentration assessed by venous blood analysis
Timepoint [1] 298563 0
Baseline (familiarisation session), immediately and 24 hours post cycling trial 1, immediately and 24 hours post cycling trial 2.
Primary outcome [2] 298584 0
Change in plasma IL-10 concentration assessed by venous blood analysis
Timepoint [2] 298584 0
Baseline (familiarisation session), immediately and 24 hours post cycling trial 1, immediately and 24 hours post cycling trial 2.
Primary outcome [3] 298585 0
Change in plasma TNFalpha concentration assessed by venous blood analysis
Timepoint [3] 298585 0
Baseline (familiarisation session), immediately and 24 hours post cycling trial 1, immediately and 24 hours post cycling trial 2.
Secondary outcome [1] 324622 0
Change in plasma IL-1beta concentration (primary outcome) assessed by venous blood analysis
Timepoint [1] 324622 0
Baseline (familiarisation session), immediately and 24 hours post cycling trial 1, immediately and 24 hours post cycling trial 2.
Secondary outcome [2] 324623 0
Change in plasma CRP concentration (primary outcome) assessed by venous blood analysis
Timepoint [2] 324623 0
Baseline (familiarisation session), immediately and 24 hours post cycling trial 1, immediately and 24 hours post cycling trial 2.
Secondary outcome [3] 324624 0
Change in plasma MCP-1 concentration (primary outcome) assessed by venous blood analysis
Timepoint [3] 324624 0
Baseline (familiarisation session), immediately and 24 hours post cycling trial 1, immediately and 24 hours post cycling trial 2.
Secondary outcome [4] 324625 0
Change in perceived muscle soreness measured via a 10cm visual analogue scale (primary outcome)
Timepoint [4] 324625 0
24 hours post cycling trial 1 and 24 hours post cycling trial 2
Secondary outcome [5] 324627 0
Change in blood glucose levels assessed by finger-prick blood test
Timepoint [5] 324627 0
Every 2 minutes of VO2max testing, in each active recovery phase of cycling trial 1 (approximately every 2min), in each active recovery phase of cycling trial 2 (approximately every 2min).
Secondary outcome [6] 324628 0
Change in blood lactate levels assessed by finger-prick blood test
Timepoint [6] 324628 0
Every 2 minutes of VO2max testing, in each active recovery phase of cycling trial 1 (approximately every 2min), in each active recovery phase of cycling trial 2 (approximately every 2min).
Secondary outcome [7] 324629 0
Change in plasma LOOH levels assessed by venous blood analysis
Timepoint [7] 324629 0
Baseline (familiarisation session), immediately and 24 hours post cycling trial 1, immediately and 24 hours post cycling trial 2.
Secondary outcome [8] 324630 0
Change in serum creatine kinase level assessed by venous blood test.
Timepoint [8] 324630 0
Baseline (familiarisation session), immediately and 24 hours post cycling trial 1, immediately and 24 hours post cycling trial 2.
Secondary outcome [9] 324631 0
Change in exercise performance, determined by the number of intervals performed (primary outcome).
Timepoint [9] 324631 0
Cycling trial 1 and cycling trial 2

Eligibility
Key inclusion criteria
Competitive cyclists training for a minimum of 7 hours per week; endurance training history of at least 3 years
Minimum age
21 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cardiovascular history; history of fainting; diabetes; history of allergy/reaction to stone fruit

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2016
Actual
1/07/2016
Date of last participant enrolment
Anticipated
19/05/2017
Actual
20/07/2017
Date of last data collection
Anticipated
Actual
4/08/2017
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 293768 0
University
Name [1] 293768 0
University of Tasmania
Country [1] 293768 0
Australia
Funding source category [2] 293769 0
Commercial sector/Industry
Name [2] 293769 0
Reid Fruits
Country [2] 293769 0
Australia
Funding source category [3] 293770 0
Commercial sector/Industry
Name [3] 293770 0
Essential Oils of Tasmania
Country [3] 293770 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
17 Liverpool Street
Hobart
TAS 7000
Country
Australia
Secondary sponsor category [1] 292598 0
None
Name [1] 292598 0
Address [1] 292598 0
Country [1] 292598 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295204 0
Tasmanian Health and Medical Human Research Ethics Committee
Ethics committee address [1] 295204 0
University of Tasmania
Churchill Avenue
Hobart
TAS 7005
Ethics committee country [1] 295204 0
Australia
Date submitted for ethics approval [1] 295204 0
21/03/2016
Approval date [1] 295204 0
10/06/2016
Ethics approval number [1] 295204 0
H0015627

Summary
Brief summary
This study will utilise a randomised, double-blind, placebo-controlled, crossover design to investigate the following aims.
1. Determine if consumption of sweet cherries attenuates exercise-induced inflammation.
2. Determine if consumption of sweet cherries improves post-exercise recovery.
3. Determine if consumption of sweet cherries improves exercise performance.
Inclusion criteria: competitive cyclists training for a minimum of 7 hours per week; an endurance training history of at least 3 years; Exclusion criteria: cardiovascular history; history of fainting; diabetes; history of allergy/reaction to stone fruit. Participants will be asked to refrain from ingesting dietary anthocyanins or flavonoids and will be provided with a food and exercise plan and diary to complete in the week prior to both the familiarisation and trial sessions. Participants will undergo an initial familiarisation session, at which time baseline blood samples will be taken. Participants will undertake a ramp incremental VO2max test to ascertain their level of cardiovascular fitness. Lactate and blood glucose measurements will be taken every 2 minutes via finger prick. Participants with a VO2max of between 4.5 and 5.0L/min will be included in the supplementation and trial sessions. Participants will be randomly assigned to the cherry or placebo group. Participants will be given blended cherry drinks containing cherries, water and lemon juice (at a ratio of 10:5:1) with an anthocyanin content of 540mg/drink or carbohydrate-matched, blended pear drinks containing 0% anthocyanin (placebo). Participants will be asked to consume one drink at 8pm for the 3 days prior to the cycling trial, and one drink 1 hour immediately prior to the commencement of the trial. To assess the efficacy of the blinding process, participants will be asked if they believe they have received the blended cherry drink or the placebo. The cycling trial will consist of 60second intervals of cycling on a cycle ergometer at a workload equivalent to 100%VO2max followed by 75 seconds of active recovery at 50%VO2max, until the 100%VO2max workload is unable to be maintained. A 10 minute warm-up and cool-down at 50%VO2max will be undertaken prior to and following the trial. Lactate and blood glucose measurements will be taken in each active recovery phase via finger prick. Venous blood samples will be collected immediately following exercise and at 24 hours post exercise. At 24 hours post exercise, participants will indicate perceived muscle soreness via a 10 cm visual analog scale. Following a washout period of at least two weeks, participant groups will crossover and the supplementation and cycling trial will be repeated. Blood samples will be tested for levels of the circulating inflammatory mediators IL-6, IL-10, TNFalpha, IL-1beta, CRP and MCP-1 using ELISA kits, and LOOH levels and creatine kinase levels will be monitored.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66486 0
Prof Justin Walls
Address 66486 0
University of Tasmania
17 Liverpool Street
Hobart
TAS 7000
Country 66486 0
Australia
Phone 66486 0
+61 03 62262662
Fax 66486 0
Email 66486 0
[email protected]
Contact person for public queries
Name 66487 0
Ms Melanie Blackhall
Address 66487 0
University of Tasmania
Private Bag 34
Hobart
TAS 7001
Country 66487 0
Australia
Phone 66487 0
+61 03 62267638
Fax 66487 0
Email 66487 0
[email protected]
Contact person for scientific queries
Name 66488 0
Ms Melanie Blackhall
Address 66488 0
University of Tasmania
Private Bag 34
Hobart
TAS 7001
Country 66488 0
Australia
Phone 66488 0
+61 03 62267638
Fax 66488 0
Email 66488 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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.