Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000332325
Ethics application status
Approved
Date submitted
2/07/2008
Date registered
15/07/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of kiwifruit on the response to moderate exercise
Scientific title
A crossover study of the effect of acute kiwifruit consumption on moderate exercise-induced oxidative stress and immune function
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
oxidative stress responses to moderate exercise 3357 0
immune cell responses to moderate exercise 3358 0
salivary hormone responses to moderate exercise 3359 0
Condition category
Condition code
Inflammatory and Immune System 3514 3514 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will consume a 60 mL fruit puree drink or placebo immediately before and after a 30 minute session of exercise on a rowing ergometer. The fruit used is derived from commercial cultivars and the dosage does not exceed the equivalent dietary recommendations. Plasma markers and salivary hormones will be monitored at several time points including before and after exercise and later that same day. The exercise session will be repeated with the alternate drink/placebo following a washout period of one week.
Intervention code [1] 3092 0
Other interventions
Comparator / control treatment
Participants will consume 60 mL of a placebo drink containing 10% sucrose and 2 mg/mL food-grade ascorbic acid. This will be consumed immediately before and after a 30 minute session of exercise on a rowing ergometer.
Control group
Placebo

Outcomes
Primary outcome [1] 4415 0
changes in plasma markers of oxidative stress, inflammation, and immunity in response to exercise following fruit puree and placebo consumption
Timepoint [1] 4415 0
immediately before and after exercise, and 1 hour later
Secondary outcome [1] 7454 0
salivary cortisol responses to exercise following fruit puree and placebo consumption
Timepoint [1] 7454 0
immediately before and after exercise, and 1 hour later

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 assigned by a single fellow scientist who is not associated with the work. No participants or trial researchers are aware of the allocation. Allocation is held concealed until completion of the trial and analysis of the data is finalised. The identification of kiwifruit and placebo drinks is concealed from trial researchers by labelling with letters.
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
9/06/2008
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] 1011 0
New Zealand
State/province [1] 1011 0

Funding & Sponsors
Funding source category [1] 3549 0
Commercial sector/Industry
Name [1] 3549 0
The New Zealand Institute for Plant and Food Research Ltd. (Plant & Food Research)
Country [1] 3549 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] 3187 0
None
Name [1] 3187 0
Address [1] 3187 0
Country [1] 3187 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5590 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 5590 0
Ministry of Health
PO Box 1031
Hamilton 3240
Ethics committee country [1] 5590 0
New Zealand
Date submitted for ethics approval [1] 5590 0
Approval date [1] 5590 0
05/03/2008
Ethics approval number [1] 5590 0
NTY/07/10/107

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

Contacts
Principal investigator
Name 28722 0
Address 28722 0
Country 28722 0
Phone 28722 0
Fax 28722 0
Email 28722 0
Contact person for public queries
Name 11879 0
Dr Roger Hurst
Address 11879 0
Plant & Food Research
Private Bag 11600
Palmerston North 4442, New Zealand
Country 11879 0
New Zealand
Phone 11879 0
+64 6 3556203
Fax 11879 0
+64 6 3517050
Email 11879 0
[email protected]
Contact person for scientific queries
Name 2807 0
Dr Roger Hurst
Address 2807 0
Plant & Food Research
Private Bag 11600
Palmerston North 4442, New Zealand
Country 2807 0
New Zealand
Phone 2807 0
+64 6 3556203
Fax 2807 0
+64 6 3517050
Email 2807 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.