Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000317392
Ethics application status
Approved
Date submitted
4/07/2008
Date registered
4/07/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of dietary supplementation with a commercial blackcurrant fruit product on health by exploring its modulation in a model of exercise-induced oxidative stress and immune function
Scientific title
A crossover study of the effect of acute blackcurrant fruit product consumption on moderate exercise-induced oxidative stress and immune function in healthy subjects
Secondary ID [1] 613 0
N/A
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
oxidative stress responses to moderate exercise 3366 0
immune function responses to moderate exercise 3367 0
Condition category
Condition code
Inflammatory and Immune System 3519 3519 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will consume an ‘off-the-shelf’ blackcurrant fruit-derived product which is in capsule form or placebo (administered orally) immediately before and immediately after a 30 minute session of exercise on a rowing ergometer.

The fruit product used is a powdered blackcurrant extract derived from commercial blackcurrant cultivars grown in New Zealand and encapsulated in gelatin. This is a commercial product available in health stores. Each capsule contains fruit extract approximately equivalent to 12 grams of fresh blackcurrants. The total anthocyanin content in each capsule is 60 milligrams.

Trial participants will be given a total of four capsules (two before and two after exercise). This is equivalent to 48 grams of fresh blackcurrants and 240 milligrams of anthocyanins.

Plasma markers will be monitored at several time points including before and after exercise and 24 hours later.

There is a one week washout period between interventions.
Intervention code [1] 3097 0
Other interventions
Comparator / control treatment
gelatin capsules containing 10% sucrose
Control group
Placebo

Outcomes
Primary outcome [1] 4419 0
Changes in plasma markers of oxidative stress in response to exercise following fruit product consumption
Timepoint [1] 4419 0
Immediately before and after exercise, and 2, 6, and 24 hours post-exercise
Secondary outcome [1] 7458 0
Changes in plasma markers of inflammation and immunity in response to exercise following fruit product consumption
Timepoint [1] 7458 0
Immediately before and after exercise, and 2, 6, and 24 hours post-exercise

Eligibility
Key inclusion criteria
Healthy persons of any gender
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Blood-borne diseases e.g. hepatitis; high/low blood pressure; pregnancy; recent viral illness and vaccinations; chronic illness affecting the immune system e.g. lupus; taking medication that affects the properties of blood e.g. clotting; unable to perform the 30 minute exercise (e.g. heart and/or breathing problems, hernia, or injury); allergies to food especially fruit.

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 is concealed. Allocation is assigned by a single fellow scientist who is not associated with the work. No participants or trial scientists undertaking the work are aware of the allocation. Allocation is held concealed until completion of the trial and analysis of the data is finalised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using coin tosses
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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
5/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 1013 0
New Zealand
State/province [1] 1013 0
Country [2] 1014 0
New Zealand
State/province [2] 1014 0

Funding & Sponsors
Funding source category [1] 3552 0
Commercial sector/Industry
Name [1] 3552 0
The New Zealand Institute for Plant and Food Research Ltd. (Plant & Food Research)
Country [1] 3552 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
The New Zealand Institute for Plant and Food Research Ltd. (Plant & Food Research)
Address
Private Bag 92169
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 3190 0
None
Name [1] 3190 0
Address [1] 3190 0
Country [1] 3190 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5594 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 5594 0
Ethics committee country [1] 5594 0
New Zealand
Date submitted for ethics approval [1] 5594 0
Approval date [1] 5594 0
05/03/2008
Ethics approval number [1] 5594 0
NTY/07/10/107

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

Contacts
Principal investigator
Name 28726 0
Address 28726 0
Country 28726 0
Phone 28726 0
Fax 28726 0
Email 28726 0
Contact person for public queries
Name 11883 0
Dr Roger Hurst
Address 11883 0
Plant & Food Research
Private Bag 11600
Palmerston North 4442, New Zealand
Country 11883 0
New Zealand
Phone 11883 0
+64 6 3556203
Fax 11883 0
+64 6 3517050
Email 11883 0
[email protected]
Contact person for scientific queries
Name 2811 0
Dr Roger Hurst
Address 2811 0
Plant & Food Research
Private Bag 11600
Palmerston North 4442, New Zealand
Country 2811 0
New Zealand
Phone 2811 0
+64 6 3556203
Fax 2811 0
+64 6 3517050
Email 2811 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
No additional documents have been identified.