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Trial registered on ANZCTR


Registration number
ACTRN12618000706279
Ethics application status
Approved
Date submitted
28/06/2017
Date registered
30/04/2018
Date last updated
13/02/2019
Date data sharing statement initially provided
13/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of high-polyphenol olive oil in cardiovascular risk markers in healthy adults
Scientific title
The effect of high-polyphenol extra virgin olive oil on markers of cardiovascular disease risk in healthy Australian adults.
Secondary ID [1] 292301 0
None
Universal Trial Number (UTN)
Trial acronym
OLIVAUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 303831 0
Mild cognitive decline 303832 0
Condition category
Condition code
Cardiovascular 303204 303204 0 0
Coronary heart disease
Neurological 303205 303205 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An extra virgin olive oil with a confirmed polyphenol count >300mg per kg. Participants will receive a 3-week supply of the high-polyphenol olive oil (1.3litres) and will be required to consume 60ml (3 tablespoons) per day for a three-week intervention phase. There will be a washout period of two weeks at the commencement of the study and between treatment arms.

Adherence will be measured by serum markers of fatty acid intake, diet diaries, and weighing the returned olive oil bottles at each 3-week followup meeting.
Intervention code [1] 298476 0
Lifestyle
Intervention code [2] 298544 0
Prevention
Comparator / control treatment
A low polyphenol olive oil with a confirmed polyphenol count <90 mg per kg will be sourced for this trial for this trial. Participants will receive a 3-week supply of the refined olive oil (1.3litres) and will be required to consume 60ml (3 tablespoons) per day for a three-week intervention phase.
Control group
Active

Outcomes
Primary outcome [1] 302580 0
HDL Cholesterol efflux via serum assay
Timepoint [1] 302580 0
Baseline and 3-week post-baseline for each treatment arm
Secondary outcome [1] 336420 0
Total antioxidant capacity via serum assay
Timepoint [1] 336420 0
Baseline and 3-week post-baseline for each treatment arm
Secondary outcome [2] 336421 0
Blood pressure
Timepoint [2] 336421 0
Baseline and 3-week post-baseline for each treatment arm
Secondary outcome [3] 336422 0
Total, HDL, LDL cholesterol and triglyceride levels via serum assay
Timepoint [3] 336422 0
Baseline and 3-week post-baseline for each treatment arm
Secondary outcome [4] 336423 0
Adverse events such as gastrointestinal symptoms, allergies or any other side-effect reported by participants during the trial. This will be recorded via patient interview at each followup timepoint.
Timepoint [4] 336423 0
Baseline, 1.5 weeks post-baseline, and 3-week post-baseline for each treatment arm
Secondary outcome [5] 336424 0
Cognitive performance using the SUCCAB cognitive battery. This includes the Stroop colour-word test, the Bond-Lader mood scale, the Depression and Anxiety Severity Scale (DASS), and tests aimed to measure short and long term memory, reaction time.
Timepoint [5] 336424 0
Baseline and 3-week post-baseline for each treatment arm
Secondary outcome [6] 336425 0
Arterial stiffness using a Sphygmacor device
Timepoint [6] 336425 0
Baseline and 3-week post-baseline for each treatment arm
Secondary outcome [7] 336710 0
Adherence using serum biomarkers of fatty acid intake, patient self-reported food diaries, and weighing returned olive oil bottles.
Timepoint [7] 336710 0
3-week post-baseline for each treatment arm.

Eligibility
Key inclusion criteria
Aged 18-75 years
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria of "Post and peri-menopausal" women has been removed. More specifically the updated list of the key exclusion criteria is as follows:
Non-English-speaking persons
• Pregnant or lactating women
• History of adverse reactions to olive oil (
• Currently prescribed warfarin, anti-coagulant therapy, statin medications, all oral hypoglycaemic agents, insulin, cyclosporine, tacrolimus, immunosuppressant agents, antihypertensive agents, and nonsteroidal anti-inflammatory drugs (hypothesised interactions), hormone replacement therapy
• A habitual diet with greater than or equal to 1 tablespoon of olive oil per day;
• Current smoker;
• Use of antioxidant supplements or medications with antioxidant properties,
• Diagnosed with any of the following conditions: hyperlipidaemia; diabetes mellitus; hypertension; inflammatory conditions (e.g. rheumatoid arthritis), intestinal disease (e.g. inflammatory bowel disease); irritable bowel syndrome, food intolerances, blood coagulation disorders, or any other physiological condition or disease that could impair adherence.
-Unstable body weight within =/>5kg weight fluctuations in the prior 3 months
-Special diet for medical reasons (i.e gluten free for coeliac disease)

Exclusion criteria for cognition component only.
-Currently prescribed antidepressant medication

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)
Allocation involves contacting a member of the research team that will have the allocation schedule and who will not have any contact with participants
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple block randomisation using a randomisation table created by computer software
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
Crossover
Other design features
Washout period of 2-weeks will be in place at the start of the trial and between the two treatment arms.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
All outcomes will be analysed by a repeated measures ANOVA, using intention-to-treat principles. Multiple imputation will be used to input missing data. Participant 3-day dietary records will be analysed for total polyphenol content and be used as a covariate. Adjusted results will be calculated using a multiple linear regression model including the stratification factors (total polyphenol intake, gender).

Recruitment
Recruitment status
Recruiting
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 in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 296844 0
University
Name [1] 296844 0
La Trobe University
Address [1] 296844 0
La Trobe University
Bundoora, Vic, 3086
Country [1] 296844 0
Australia
Funding source category [2] 296846 0
Commercial sector/Industry
Name [2] 296846 0
Cobram Estate Olive Oil
Address [2] 296846 0
14/75 Lorimer St, Southbank VIC 3006
Country [2] 296846 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Bundoora, Vic, 3086
Country
Australia
Secondary sponsor category [1] 295841 0
None
Name [1] 295841 0
Address [1] 295841 0
Country [1] 295841 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298075 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 298075 0
La Trobe University,
Bundoora, Vic, 3086
Ethics committee country [1] 298075 0
Australia
Date submitted for ethics approval [1] 298075 0
03/07/2017
Approval date [1] 298075 0
11/09/2017
Ethics approval number [1] 298075 0
HEC17-067

Summary
Brief summary
Purpose of study
Extra virgin olive oil, a key ingredient of the cardioprotective Mediterranean diet, is considered a healthy source of dietary fat due to its high content of monounsaturated fatty acids and antioxidant polyphenols. However, while consistent, promising evidence exists, the unique contribution of polyphenols to the cardioprotective effect of olive oil is not fully established. This study will examine the effect of high-polyphenol extra virgin olive oil versus low-polyphenol olive oil on markers of cardiovascular disease risk that are related to cholesterol metabolism and total antioxidant capacity as well as measures of cognitive function.
Hypothesis: Compared with a low polyphenol olive oil, a high polyphenol olive oil intervention will result in improved measures of HDL cholesterol efflux and total antioxidant capacity in a healthy adult population.
Objectives
1. Efficacy. Efficacy outcomes include HDL cholesterol efflux, total antioxidant capacity, cholesterol levels (total, HDL, LDL, triglycerides), cognitive performance, and blood pressure.
2. Safety. Safety outcomes include adverse and serious adverse events directly attributable to the intervention period.
3. Adherence. Adherence outcomes will include biomarkers related to monounsaturated fat intake, bottle count, self-report checklist, and patient interview.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75910 0
Dr George Moschonis
Address 75910 0
La Trobe University,
Bundoora, Victoria, 3086
Country 75910 0
Australia
Phone 75910 0
+61 3 9479 3482
Fax 75910 0
Email 75910 0
g.moschonis@latrobe.edu.au
Contact person for public queries
Name 75911 0
Dr George Moschonis
Address 75911 0
La Trobe University,
Bundoora, Victoria, 3086
Country 75911 0
Australia
Phone 75911 0
+61 3 9479 3482
Fax 75911 0
Email 75911 0
g.moschonis@latrobe.edu.au
Contact person for scientific queries
Name 75912 0
Dr George Moschonis
Address 75912 0
La Trobe University,
Bundoora, Victoria, 3086
Country 75912 0
Australia
Phone 75912 0
+61 3 9479 3482
Fax 75912 0
Email 75912 0
g.moschonis@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All participant data after de identification will be available for sharing as required.
When will data be available (start and end dates)?
Data will be available immediately following publication and for the duration of 5 years whereby records will be maintained as described in ethics in adherence to La Trobe University policies.
Available to whom?
Data will be made available to journals when required for publication and otherwise supplied to individuals on a case by case basis as determined by the principle investigator.
Available for what types of analyses?
Data will be available for meta analysis and for the proposed aims of the study.
How or where can data be obtained?
Access will be subject to principle investigator approval and with the requirement of data access agreements where required this will also be assessed on a case by case basis but for E.g. not required for meta analysis data requests.
What supporting documents are/will be available?
Ethical approval
Summary results
No Results