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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?
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.
Secondary ID [1] 253249 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insulin sensitivity 258777 0
Condition category
Condition code
Metabolic and Endocrine 258920 258920 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 257713 0
Treatment: Other
Comparator / control treatment
placebo control. The placebo is capsulated safflower oil provided once daily for 12 weeks orally.
Control group
Placebo

Outcomes
Primary outcome [1] 259786 0
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
Timepoint [1] 259786 0
Baseline
End of Intervention one (placebo or oleuropein depending in randomization)
End of intervention two. (placebo or oleuropein depending in randomization)
Secondary outcome [1] 268563 0
Body composition (DEXA)
Timepoint [1] 268563 0
Baseline
End of Intervention one (placebo or oleuropein depending in randomization)
End of intervention two. (placebo or oleuropein depending in randomization)
Secondary outcome [2] 268564 0
24 hour blood pressure monitoring
Timepoint [2] 268564 0
Baseline
End of Intervention one (placebo or oleuropein depending in randomization)
End of intervention two. (placebo or oleuropein depending in randomization)
Secondary outcome [3] 268565 0
Wellness questionairre
Timepoint [3] 268565 0
Baseline
End of Intervention one (placebo or oleuropein depending in randomization)
End of intervention two. (placebo or oleuropein depending in randomization)
Secondary outcome [4] 268566 0
Hand grip strength
Measured with a Jamar dynamometer.
Timepoint [4] 268566 0
Baseline
End of Intervention one (placebo or oleuropein depending in randomization)
End of intervention two. (placebo or oleuropein depending in randomization)
Secondary outcome [5] 268568 0
Resting Energy Expenditure was determined by indirect calirometry using a TrueOne 2400 Metabolic Measurement system (Parvo Medics Inc., Yorba Sandy, Utah).
Timepoint [5] 268568 0
Baseline
End of Intervention one (placebo or oleuropein depending in randomization)
End of intervention two. (placebo or oleuropein depending in randomization)
Secondary outcome [6] 298375 0
Carotid Intima Thickness measurement - measured by ultrasound
Timepoint [6] 298375 0
Baseline End of Intervention one (placebo or oleuropein depending in randomization) End of intervention two. (placebo or oleuropein depending in randomization)
Secondary outcome [7] 298376 0
Fasting blood sample for lipid profile: LDL, HDL and total cholesterol
Timepoint [7] 298376 0
Baseline End of Intervention one (placebo or oleuropein depending in randomization) End of intervention two. (placebo or oleuropein depending in randomization).
Secondary outcome [8] 298377 0
Fasting blood sample for liver function tests: AST, ALT, ALP, GGT
Timepoint [8] 298377 0
Baseline End of Intervention one (placebo or oleuropein depending in randomization) End of intervention two. (placebo or oleuropein depending in randomization).
Secondary outcome [9] 298378 0
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
Timepoint [9] 298378 0
Baseline End of Intervention one (placebo or oleuropein depending in randomization) End of intervention two. (placebo or oleuropein depending in randomization
Secondary outcome [10] 298379 0
Fasting blood sample for Oxidised LDL
Timepoint [10] 298379 0
Baseline End of Intervention one (placebo or oleuropein depending in randomization) End of intervention two. (placebo or oleuropein depending in randomization

Eligibility
Key inclusion criteria
Males aged 35 to 55.
BMI 25 - 30
Minimum age
35 Years
Maximum age
55 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any medications
BMI outside inclusion range
Smokers
Diabetes
Cardiovascular disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generation - random number allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3079 0
New Zealand
State/province [1] 3079 0

Funding & Sponsors
Funding source category [1] 258178 0
Commercial sector/Industry
Name [1] 258178 0
Comvita
Address [1] 258178 0
Comvita New Zealand Ltd
23 Wilson Road South
Paengaroa
Te Puke
Bay of Plenty 3189
Country [1] 258178 0
New Zealand
Primary sponsor type
University
Name
University of Auckland / Liggins Institute
Address
2 - 6 Park Ave
Grafton
Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 257353 0
None
Name [1] 257353 0
Address [1] 257353 0
Country [1] 257353 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260168 0
Northern Regional Y eithics committee
Ethics committee address [1] 260168 0
354 Victoria Street, PO BOX 1031, Hamilton, 3204
Ethics committee country [1] 260168 0
New Zealand
Date submitted for ethics approval [1] 260168 0
01/02/2011
Approval date [1] 260168 0
06/11/2011
Ethics approval number [1] 260168 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31995 0
Address 31995 0
Country 31995 0
Phone 31995 0
Fax 31995 0
Email 31995 0
Contact person for public queries
Name 15242 0
Martin de Bock
Address 15242 0
Liggins Institute
2-6 Park Avenue
Grafton
Auckland 1010
Country 15242 0
New Zealand
Phone 15242 0
0064992382769
Fax 15242 0
Email 15242 0
m.debock@auckland.ac.nz
Contact person for scientific queries
Name 6170 0
Martin de Bock
Address 6170 0
Liggins Institute
2-6 Park Avenue
Grafton
Auckland 1010
Country 6170 0
New Zealand
Phone 6170 0
0064992382769
Fax 6170 0
Email 6170 0
m.debock@auckland.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary