Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000529246
Ethics application status
Approved
Date submitted
19/03/2018
Date registered
10/04/2018
Date last updated
6/03/2023
Date data sharing statement initially provided
6/03/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of long term storage on blackcurrant juice bioactivity in improving measures of exercise performance and recovery.
Scientific title
The effect of long term storage on the acute bioefficacy of blackcurrant juice in reducing blood plasma biomarkers of exercise-induced oxidative stress following a sustained medium-intensity cycle bout in healthy volunteers
Secondary ID [1] 294032 0
Nil known
Universal Trial Number (UTN)
U1111-1204-0395
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise-induced oxidative stress 306569 0
Condition category
Condition code
Inflammatory and Immune System 305664 305664 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a double-blind, placebo controlled, parallel design intervention study that will allow us to evaluate whether long term storage affects the ability of blackcurrant juice to manage exercise-induced oxidative stress. Prospective participants who have passed the study's inclusion/exclusion criteria will be asked to attend a familiarisation session where they will meet with the study’s principal investigator. During this session, the study’s principal investigator (research scientist, PhD) will introduced them to the subjective scales and questionnaire that they will be asked to respond to during the trial days. Participants will also be asked to perform a high intensity cycle exercise test to estimate their maximal aerobic capacity that will allow us to estimate the intensity of the exercise relative to their fitness level that they will be required to perform on the trail days.

Participants recruited to this study will be randomised into two treatment groups: (1) Blackcurrant group and (2) Placebo group. On the first trial day, co-investigators of this study will give participants a volume of ultra-high temperature (UHT) processed blackcurrant juice to consume. The volume of juice that participants will consume will contain a dose of anthocyanins relative to their bodyweights (3.2 mg anthocyanins/kg bodyweight). The exact volume of blackcurrant juice that participants will be asked to consume will be determined by the anthocyanin content in our batch of blackcurrant juice post UHT processing, which will be determined in-house. Those allocated to the Placebo treatment group will be asked to consume a drink containing the equivalent sugar (glucose, fructose and sucrose) present in the blackcurrant dose employed in this study. After quickly consuming their allocated treatment drinks (within 2 minutes), participants will be asked to sit in the waiting room provided in the clinical facility and refrain from any exercise for 1 hr. Following this, participants will be asked to perform a 30 minute cycle exercise relative to 65% of their maximal aerobic capacity. At the end of the exercise, participants will be required to rest for 30 min in the waiting room during which their recovery from the exercise will be monitored. The principal investigator of this study will be instructing all participants of what is required of them on their main trial day.

Following a period of long term storage, all recruited participants will be required to return to complete a second trial day. Each participant will be given the same volume of blackcurrant juice and placebo drink that they consumed during their initial trial day and also required to undergo the same exercise and trial procedures that they performed on their first trial day. We aim to run the second trial day at a storage timepoint which is pertinent to the market practice and when we have data demonstrating any changes in the levels of anthocyanins in our batch of blackcurrant juice. To help determine this timepoint, we will be measuring the anthocyanin levels in our juice weekly for the first six weeks post-processing, then every month subsequently for up to 12 months post UHT processing. This information will be relayed to our industry partner who will advise on a storage timepoint to start the next second trial day based on their industry practice and commercial viability. Therefore, we cannot yet give a definitive date for the second trial day nor can we provide a determinant for when start the second trial day as we do not know the effect of storage on the concentration of anthocyanins in our batch of pasteurised juice.
Intervention code [1] 300305 0
Treatment: Other
Comparator / control treatment
The Placebo drink will contain the equivalent amount of sugar (glucose, fructose and sucrose) in the treatment intervention. Because our treatment intervention is normalised to each individual’s body weight, the quantities of sugar will vary for each individual. All treatment drinks will be served in opaque bottles to blind both participants and trial investigators to which treatment is being administered.
Control group
Placebo

Outcomes
Primary outcome [1] 305143 0
Composite primary exercise performance parameters will include power output and exercise duration (distance) during the cycling exercises.
Timepoint [1] 305143 0
During the cycle exercises on the familiarisation and trial days, the cycle ergometer’s computer will be continuously measuring and recording power output and exercise duration (distance) to give a profile of each individual’s performance for these parameters over their cycle bouts. This complete data set will be subsequently downloaded for analysis.
Primary outcome [2] 305145 0
Measures of cardiopulomary exercise performance and recovery (heart rate and oxygen/carbon dioxide exchange) will be measured throughout the maximal and submaximal cycle exercise and recovery during the familiarisation and trial days, respectively.
Timepoint [2] 305145 0
Heart rate and oxygen/carbon dioxide exchange will be measured through the duration of the maximal cycle exercise on the familiarisation days to determine the maximal oxygen aerobic capacity (VO2 max) of participants. Heart rate and oxygen/carbon dioxide exchange will also be measured throughout the duration of the submaximal cycle exercise and 30 min exercise recovery period on the main trial day. Heart rate will be measured using a chest-worn heart rate monitor and oxygen/carbon dioxide exchange will be measured using a breath-by-breath cardiopulmonary exercise testing (CPET) machine.
Primary outcome [3] 305147 0
Biochemical measures of oxidative stress and recovery (plasma oxidative capacity, malondialdehyde, protein carbonyls and lactate) will be measured from plasma or whole blood samples.
Timepoint [3] 305147 0
All markers of oxidative stress will be measured from blood samples collected prior to consuming treatment drink, 1 hour after treatment consumption, immediately after the cycling exercise and 30 minutes after the cycling exercise using commercial assay kits or assays developed in-house. Lactate will be measured using a "point of care" biosensor from finger prick samples.
Secondary outcome [1] 344308 0
Plasma anthocyanin levels will be measured in blood samples collected from participants as a measure of bioavailability.
Timepoint [1] 344308 0
This will be measured from blood samples collected prior to treatment consumption, 1 hour after treatment consumption and immediately after the submaximal exercise cycle during the main trial day using validated in-house high performance liquid chromatography (HPLC) methods.
Secondary outcome [2] 344312 0
Plasma/whole blood antioxidant activity (glutathione peroxidase, superoxide dismutase and ferric reducing capacity) will be measured from venous blood.
Timepoint [2] 344312 0
These biomarkers for antioxidant activity will be measured from venous blood collected before treatment consumption, 1 hour after treatment consumption, immediately after the submaximal exercise and 30 minutes after the submaximal exercise using commercial in-house assays or validated in-house assays.
Secondary outcome [3] 344315 0
Rating of Perceived Exertion (RPE) as a subjective measure of effort will be measured at regular intervals using a Borg RPE visual analogue scale during the cycling exercises on the familiarisation and trail days.
Timepoint [3] 344315 0
Participants will be asked to give an RPE score at 2 minute intervals during the maximal cycling tests on the familiarisation day. Participants will also be asked to give an RPE score every 5 minutes during the 30 minute submaximal cycle on the main trial day.

Eligibility
Key inclusion criteria
Healthy individuals who are not involved in any exercise training regime and can complete the physical requirements of the exercises (determined from the familiarisation day) will be selected for this study. Participants will be required to complete a health questionnaire and provide written consent for this study.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they are unwilling or unable to provide informed written consent or comply with the study procedures. Participants will also be excluded if they have (i) known hypersensitivity or intolerance to blackcurrants or berry fruit-derived products, (ii) have health conditions that impair their ability to perform the exercises or may be aggravated by the exercises in this study (e.g. injury, hernia, back or joint pain, cardiovascular and breathing problems), (iii) have a Sports Index score of 4.5 or greater as assessed by a Baecke habitual physical activity questionnaire, (iv) or are unable to perform the exercises to the standard required by the trial coordinator during the familiarisation session. In addition, participants will be excluded if they are pregnant, planning to get pregnant in the near future or have any of the following conditions: (i) blood borne diseases (e.g. hepatitis), (ii) clinically diagnosed high/low blood pressure, (iii) recent bacterial or viral illness or (iv) are taking medication that affects the properties of blood (e.g. blood clotting).

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)
This is a double-blind, placebo controlled, parallel design intervention study. Participants will be randomly allocated into one of two groups: Group 1 - Blackcurrant group and Group 2 - Placebo group. Study investigators and participants will be blinded from the dietary intervention. Treatment allocation for each participant will be undertaken by a fellow scientist not involved in this study. Participant treatment allocation is held and concealed until completion of the trial and analysis of the data is finished. Furthermore, the placebo treatment drink will be matched to have a similar colour as the blackcurrant drink and participants will be asked to consume the treatment juice as quickly as they can from an opaque food safe drink bottle.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation of participants into one of the two treatment groups will be performed using a spreadsheet random function.
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be expressed as mean +/- standard error. Interaction between consumption of blackcurrant juice and parameters of physiological (exercise and cardiopulmonary) performance will be determined. Likewise, interaction between consumption of blackcurrant juice and modulation of biochemical markers for oxidative stress detailed in this study and how these relate to physiological and subjective measures will be determined. Statistical significance for the comparison between Blackcurrant and Placebo groups will be assessed using Student's two-sample t-test. Multiple comparisons will be assessed by two-way ANOVA. Where appropriate, the original data will be transformed to achieve normality and constant variance in the residuals. Statistical significance for all indices will be set at P < 0.05 with a confidence level of 95%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/03/2018
Date of last participant enrolment
Anticipated
13/04/2018
Actual
4/04/2019
Date of last data collection
Anticipated
31/05/2019
Actual
18/04/2019
Sample size
Target
30
Accrual to date
Final
43
Recruitment outside Australia
Country [1] 9679 0
New Zealand
State/province [1] 9679 0
Manawatu

Funding & Sponsors
Funding source category [1] 298658 0
Government body
Name [1] 298658 0
The New Zealand Institute for Plant & Food Research Ltd.
Country [1] 298658 0
New Zealand
Funding source category [2] 298963 0
Commercial sector/Industry
Name [2] 298963 0
New Zealand Blackcurrant Cooperative
Country [2] 298963 0
New Zealand
Primary sponsor type
Individual
Name
Dr. Jocelyn Eason
Address
The New Zealand Institute of Plant & Food Research
Batchelar Road,
Fitzherbert,
Palmerston North 4474
Country
New Zealand
Secondary sponsor category [1] 297827 0
Individual
Name [1] 297827 0
Andrew Simpson
Address [1] 297827 0
The New Zealand Institute of Plant & Food Research
Batchelar Road,
Fitzherbert,
Palmerston North 4474
Country [1] 297827 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299613 0
Health and Disability Ethics Committees
Ethics committee address [1] 299613 0
Ethics committee country [1] 299613 0
New Zealand
Date submitted for ethics approval [1] 299613 0
20/12/2017
Approval date [1] 299613 0
09/03/2018
Ethics approval number [1] 299613 0
17/STH/250

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

Contacts
Principal investigator
Name 81030 0
Dr Dominic Lomiwes
Address 81030 0
The New Zealand Institute of Plant & Food Research Ltd.
Batchelar Road
Private Bag 11600
Palmerston North 4442
Country 81030 0
New Zealand
Phone 81030 0
+64 6 355 6113
Fax 81030 0
+64 6 351 7050
Email 81030 0
[email protected]
Contact person for public queries
Name 81031 0
Roger Hurst
Address 81031 0
The New Zealand Institute of Plant & Food Research Ltd.
Batchelar Road
Private Bag 11600
Palmerston North 4442
Country 81031 0
New Zealand
Phone 81031 0
+64 6 953 7677
Fax 81031 0
+64 6 351 7050
Email 81031 0
[email protected]
Contact person for scientific queries
Name 81032 0
Dominic Lomiwes
Address 81032 0
The New Zealand Institute of Plant & Food Research Ltd.
Batchelar Road
Private Bag 11600
Palmerston North 4442
Country 81032 0
New Zealand
Phone 81032 0
+64 6 355 6113
Fax 81032 0
+64 6 351 7050
Email 81032 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18499Ethical approval    374493-(Uploaded-03-04-2020-14-57-17)-Study-related document.pdf



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.