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Trial registered on ANZCTR
Registration number
ACTRN12610001082099
Ethics application status
Approved
Date submitted
7/12/2010
Date registered
8/12/2010
Date last updated
18/07/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
Can olive leaf extract reduce the risk of metabolic disease?
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Scientific title
Can olive leaf extract improve insulin sensitivity in middle aged males? A randomized cross-over trial of olive leaf extract in males aged 35 -55, with a body mass index of 25 - 30.
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Secondary ID [1]
253249
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none
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Insulin sensitivity
258777
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Condition category
Condition code
Metabolic and Endocrine
258920
258920
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Olive leaf extract (Oleuropein) 66mg (15mL), oral once daily for 12 weeks. Crossed over to placebo with a 6 week washout between interventions. There will be no lead in period.
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Intervention code [1]
257713
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Treatment: Other
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Comparator / control treatment
placebo control. The placebo is capsulated safflower oil provided once daily for 12 weeks orally.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Insulin sensitivity. THis will be measured by the Matsuda methodl which is best model compared to the euglycaemic clamp. This involved overnight fasting, with an oral glucose tolerance test. Equipment used will be IV cannulation, and syringes. The Liggins Institute has an in-house assay for insulin level.s
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Assessment method [1]
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Timepoint [1]
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Baseline
End of Intervention one (placebo or oleuropein depending in randomization)
End of intervention two. (placebo or oleuropein depending in randomization)
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Secondary outcome [1]
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Body composition (DEXA)
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Assessment method [1]
268563
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Timepoint [1]
268563
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Baseline
End of Intervention one (placebo or oleuropein depending in randomization)
End of intervention two. (placebo or oleuropein depending in randomization)
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Secondary outcome [2]
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24 hour blood pressure monitoring
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Assessment method [2]
268564
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Timepoint [2]
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Baseline
End of Intervention one (placebo or oleuropein depending in randomization)
End of intervention two. (placebo or oleuropein depending in randomization)
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Secondary outcome [3]
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Wellness questionairre
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Assessment method [3]
268565
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Timepoint [3]
268565
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Baseline
End of Intervention one (placebo or oleuropein depending in randomization)
End of intervention two. (placebo or oleuropein depending in randomization)
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Secondary outcome [4]
268566
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Hand grip strength
Measured with a Jamar dynamometer.
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Assessment method [4]
268566
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Timepoint [4]
268566
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Baseline
End of Intervention one (placebo or oleuropein depending in randomization)
End of intervention two. (placebo or oleuropein depending in randomization)
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Secondary outcome [5]
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Resting Energy Expenditure was determined by indirect calirometry using a TrueOne 2400 Metabolic Measurement system (Parvo Medics Inc., Yorba Sandy, Utah).
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Assessment method [5]
268568
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Timepoint [5]
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Baseline
End of Intervention one (placebo or oleuropein depending in randomization)
End of intervention two. (placebo or oleuropein depending in randomization)
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Secondary outcome [6]
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Carotid Intima Thickness measurement - measured by ultrasound
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Assessment method [6]
298375
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Timepoint [6]
298375
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Baseline End of Intervention one (placebo or oleuropein depending in randomization) End of intervention two. (placebo or oleuropein depending in randomization)
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Secondary outcome [7]
298376
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Fasting blood sample for lipid profile: LDL, HDL and total cholesterol
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Assessment method [7]
298376
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Timepoint [7]
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Baseline End of Intervention one (placebo or oleuropein depending in randomization) End of intervention two. (placebo or oleuropein depending in randomization).
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Secondary outcome [8]
298377
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Fasting blood sample for liver function tests: AST, ALT, ALP, GGT
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Assessment method [8]
298377
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Timepoint [8]
298377
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Baseline End of Intervention one (placebo or oleuropein depending in randomization) End of intervention two. (placebo or oleuropein depending in randomization).
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Secondary outcome [9]
298378
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Fasting blood sample for Cytokines that influence insulin sensitivity: Interleukin 6 (IL-6), IL-8, tumour necrosis factor alpha, ultrasensitive CRP, Insulin like growth facotr binding protein 1 (IGBBP1), IGFBP2, IGFBP3
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Assessment method [9]
298378
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Timepoint [9]
298378
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Baseline End of Intervention one (placebo or oleuropein depending in randomization) End of intervention two. (placebo or oleuropein depending in randomization
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Secondary outcome [10]
298379
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Fasting blood sample for Oxidised LDL
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Assessment method [10]
298379
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Timepoint [10]
298379
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Baseline End of Intervention one (placebo or oleuropein depending in randomization) End of intervention two. (placebo or oleuropein depending in randomization
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Eligibility
Key inclusion criteria
Males aged 35 to 55.
BMI 25 - 30
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Minimum age
35
Years
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Maximum age
55
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Any medications
BMI outside inclusion range
Smokers
Diabetes
Cardiovascular disease.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
Blinding by coding, key to code kept by Olive leaf extract supplier (Comvita)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generation - random number allocation.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/04/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
3079
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New Zealand
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State/province [1]
3079
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Funding & Sponsors
Funding source category [1]
258178
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Commercial sector/Industry
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Name [1]
258178
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Comvita
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Address [1]
258178
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Comvita New Zealand Ltd
23 Wilson Road South
Paengaroa
Te Puke
Bay of Plenty 3189
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Country [1]
258178
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New Zealand
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Primary sponsor type
University
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Name
University of Auckland / Liggins Institute
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Address
2 - 6 Park Ave
Grafton
Auckland 1010
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Country
New Zealand
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Secondary sponsor category [1]
257353
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None
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Name [1]
257353
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Address [1]
257353
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Country [1]
257353
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Northern Regional Y eithics committee
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Ethics committee address [1]
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354 Victoria Street, PO BOX 1031, Hamilton, 3204
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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01/02/2011
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Approval date [1]
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06/11/2011
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Ethics approval number [1]
260168
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Summary
Brief summary
The purpose of the study is to formally assess the impact of olive leaf extract on insulin sensitivity. It will be given as a supplement, without altering other aspects of diet or lifestyle.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
31995
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Address
31995
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Country
31995
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Phone
31995
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Fax
31995
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Email
31995
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Contact person for public queries
Name
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Martin de Bock
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Address
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Liggins Institute
2-6 Park Avenue
Grafton
Auckland 1010
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Country
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New Zealand
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Phone
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0064992382769
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Fax
15242
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Email
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[email protected]
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Contact person for scientific queries
Name
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Martin de Bock
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Address
6170
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Liggins Institute
2-6 Park Avenue
Grafton
Auckland 1010
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Country
6170
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New Zealand
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Phone
6170
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0064992382769
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Fax
6170
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Email
6170
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[email protected]
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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.
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