Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000328279p
Ethics application status
Not yet submitted
Date submitted
23/02/2018
Date registered
6/03/2018
Date last updated
6/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Olive Leaf Extract on Upper Respiratory Illness in High School Athletes
Scientific title
The Effect of Olive Leaf Extract on Upper Respiratory Illness in High School Athletes
Secondary ID [1] 294144 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper Respiratory Illness 306772 0
Condition category
Condition code
Respiratory 305891 305891 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Olive Leaf Extract (OLE), equivalent of 7 grams of fresh leaf, given daily for two months

Participants will be given the tablets and asked to return them at the end of the intervention period. The remaining tablets will be counted and measured as a percentage of compliance
Intervention code [1] 300434 0
Prevention
Intervention code [2] 300451 0
Treatment: Other
Comparator / control treatment
Tablet the same size and shape as the intervention but no OLE. The contents of the tablet will be gluten-free cornstarch
Control group
Placebo

Outcomes
Primary outcome [1] 304909 0
Effect of OLE on URI incidence presented as mean URI incidence per 1000 non-illness days (expressed as mean ± standard deviation) as reported by the self administered questionnaire.

The questionnaire has been developed in our laboratory and used our previous research. In the questionnaire, participants are asked firstly if they have had a cold (a common representation of a URI), and then asked to rate any symptoms they have had for more than 48 hours (nasal, sore throat, cough, sneezing). The symptoms are rated as not applicable (zero) or on a scale of 1-3; 1 being “No Training Impact”, 2 being “Some Training Impact” and 3 being “No Training/ In Bed”, generating a symptom score out of 12. A participant is classified as having a URI if they answered “yes” to having a cold and/or their total symptom score was = 4.
Timepoint [1] 304909 0
Two months after randomisation
Primary outcome [2] 304934 0
Effect of OLE on URI duration presented as mean URI duration per 1000 non-illness days (expressed as mean ± standard deviation) as reported by the self administered questionnaire

The questionnaire has been developed in our laboratory and used our previous research. In the questionnaire, participants are asked firstly if they have had a cold (a common representation of a URI), and then asked to rate any symptoms they have had for more than 48 hours (nasal, sore throat, cough, sneezing). The symptoms are rated as not applicable (zero) or on a scale of 1-3; 1 being “No Training Impact”, 2 being “Some Training Impact” and 3 being “No Training/ In Bed”, generating a symptom score out of 12. A participant is classified as having a URI if they answered “yes” to having a cold and/or their total symptom score was = 4.
Timepoint [2] 304934 0
Two months after randomisation
Secondary outcome [1] 343593 0
Effect of OLE on URI incidence in different sports presented as mean URI incidence per 1000 non-illness days (expressed as mean ± standard deviation) as reported by the self administered questionnaire

The questionnaire has been developed in our laboratory and used our previous research. In the questionnaire, participants are asked firstly if they have had a cold (a common representation of a URI), and then asked to rate any symptoms they have had for more than 48 hours (nasal, sore throat, cough, sneezing). The symptoms are rated as not applicable (zero) or on a scale of 1-3; 1 being “No Training Impact”, 2 being “Some Training Impact” and 3 being “No Training/ In Bed”, generating a symptom score out of 12. A participant is classified as having a URI if they answered “yes” to having a cold and/or their total symptom score was = 4.
Timepoint [1] 343593 0
Two months after randomisation

Eligibility
Key inclusion criteria
High school students who play top level sport for their school
Minimum age
12 Years
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently smoke, have asthma and/or have a history of (or currently have) a respiratory illness

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/04/2018
Actual
Date of last participant enrolment
Anticipated
3/09/2018
Actual
Date of last data collection
Anticipated
21/12/2018
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 9621 0
New Zealand
State/province [1] 9621 0
Auckland

Funding & Sponsors
Funding source category [1] 298780 0
University
Name [1] 298780 0
The University of Auckland
Country [1] 298780 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
FMHS Campus, The University of Auckland, Department of Nutrition and Dietetics, 85 Park Road, Grafton, Auckland, New Zealand
Country
New Zealand
Secondary sponsor category [1] 297963 0
None
Name [1] 297963 0
N/A
Address [1] 297963 0
N/A
Country [1] 297963 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 299724 0
Health and Disability Ethics Committee
Ethics committee address [1] 299724 0
Ethics committee country [1] 299724 0
Date submitted for ethics approval [1] 299724 0
08/03/2018
Approval date [1] 299724 0
Ethics approval number [1] 299724 0

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

Contacts
Principal investigator
Name 81378 0
Dr Andrea Braakhuis
Address 81378 0
FMHS Campus, The University of Auckland, Department of Nutrition and Dietetics, 85 Park Road, Grafton, Auckland
Country 81378 0
New Zealand
Phone 81378 0
+6499236251
Fax 81378 0
Email 81378 0
[email protected]
Contact person for public queries
Name 81379 0
Vaughan Somerville
Address 81379 0
FMHS Campus, The University of Auckland, Department of Nutrition and Dietetics, 85 Park Road, Grafton, Auckland
Country 81379 0
New Zealand
Phone 81379 0
+64211814362
Fax 81379 0
Email 81379 0
[email protected]
Contact person for scientific queries
Name 81380 0
Vaughan Somerville
Address 81380 0
FMHS Campus, The University of Auckland, Department of Nutrition and Dietetics, 85 Park Road, Grafton, Auckland
Country 81380 0
New Zealand
Phone 81380 0
+64211814362
Fax 81380 0
Email 81380 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.