Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001021561
Ethics application status
Approved
Date submitted
31/08/2015
Date registered
1/10/2015
Date last updated
1/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Olive Leaf Extract on gene expression, diet and energy in healthy male participants
Scientific title
Effect of Olive Leaf Extract on gene expression, diet and energy in healthy male participants
Secondary ID [1] 287386 0
Nil
Universal Trial Number (UTN)
U1111-1166-7300
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammation 296081 0
Condition category
Condition code
Diet and Nutrition 296342 296342 0 0
Other diet and nutrition disorders
Alternative and Complementary Medicine 296388 296388 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
It is an Olive Leaf Extract, made by Comvita Ltd. Currently on the market.
10ml twice a day
8 weeks taken
oral- in a liquid, given a measuring spoon
bottles of Olive Leaf extract returned at end to measure how much was taken
Intervention code [1] 292735 0
Prevention
Comparator / control treatment
Placebo:

Vegetable glycerin and flavours and colours listed below.
Sucrose octa acetate
Caramel colour
Damascenone
Guaiacol
Eugenol

in liquid form, to be taken same quantities as Olive leaf extract
Control group
Placebo

Outcomes
Primary outcome [1] 295994 0
Gene expression will be analysed from blood samples, this will include inflammatory markers such as IL-8, COX-2 and TNF
Timepoint [1] 295994 0
after participants have been recruited they will take the supplement for 8 weeks. Blood sample is taken at the baseline and 8 weeks from the baseline blood sample.
Secondary outcome [1] 317121 0
Will measure the diet of participants by food diary and analyse with Foodworks 2012
Timepoint [1] 317121 0
Measure the food diary at the start and end of the 8 week intervention
Secondary outcome [2] 317292 0
Measure if energy has improved by questionnaires- start and end of intervention
Timepoint [2] 317292 0
8 weeks from start of intervention to completion

Eligibility
Key inclusion criteria
Healthy, non-smokers, able to reach the The University of Auckland campus, male
Minimum age
20 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smokers, female

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)
Notices in elevators at university and surrounding area.

numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer random number generator
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
Placebo controlled.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
ANOVA and linear model both used to compare gene expression changes after taking Olive Leaf extract.
To detect a significant change (0.05) with a power of >80% in the JUN gene between the intervention groups, 30 participants are required. This was determined using the SD of a change in JUN in healthy people for a study using a similar nutracuetical.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
27/04/2015
Actual
1/05/2015
Date of last participant enrolment
Anticipated
30/05/2015
Actual
17/06/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
29
Recruitment outside Australia
Country [1] 7130 0
New Zealand
State/province [1] 7130 0
Auckland

Funding & Sponsors
Funding source category [1] 291952 0
Commercial sector/Industry
Name [1] 291952 0
Comvita Innovation Ltd
Country [1] 291952 0
New Zealand
Primary sponsor type
University
Name
The University of Auckand
Address
85 Park Rd
Grafton Campus
Auckland
1010
Country
New Zealand
Secondary sponsor category [1] 290619 0
Government body
Name [1] 290619 0
Callaghan Innovation
Address [1] 290619 0
Level 8
139 Quay st
Auckland
1010
Country [1] 290619 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293447 0
HDEC- Health and Ethics Disability Committee New Zealand
Ethics committee address [1] 293447 0
Ethics committee country [1] 293447 0
New Zealand
Date submitted for ethics approval [1] 293447 0
30/04/2015
Approval date [1] 293447 0
21/05/2015
Ethics approval number [1] 293447 0
15/NTB/27/AM01

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 549 549 0 0
/AnzctrAttachments/369227-Olive leaf extract project.docx
Attachments [2] 550 550 0 0
/AnzctrAttachments/369227-Consent form OLE 25 April-1.doc
Attachments [3] 551 551 0 0
/AnzctrAttachments/369227-Participant Information sheet May -2.doc
Attachments [4] 555 555 0 0
/AnzctrAttachments/369227-Protocol April (1).doc

Contacts
Principal investigator
Name 59966 0
Miss Anna Boss
Address 59966 0
The University of Auckland
Nutrition Department
85 Park Rd
Grafton Campus
Grafton
1010
Country 59966 0
New Zealand
Phone 59966 0
+64 9 923 6513
Fax 59966 0
Email 59966 0
[email protected]
Contact person for public queries
Name 59967 0
Anna Boss
Address 59967 0
The University of Auckland
Nutrition Department
85 Park Rd
Grafton Campus
Grafton
1010
Country 59967 0
New Zealand
Phone 59967 0
+64 9 923 6513
Fax 59967 0
Email 59967 0
[email protected]
Contact person for scientific queries
Name 59968 0
Anna Boss
Address 59968 0
The University of Auckland
Nutrition Department
85 Park Rd
Grafton Campus
Grafton
1010
Country 59968 0
New Zealand
Phone 59968 0
+64 9 923 6513
Fax 59968 0
Email 59968 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
SourceTitleYear of PublicationDOI
EmbaseHuman intervention study to assess the effects of supplementation with olive leaf extract on peripheral blood mononuclear cell gene expression.2016https://dx.doi.org/10.3390/ijms17122019
N.B. These documents automatically identified may not have been verified by the study sponsor.