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Trial registered on ANZCTR


Registration number
ACTRN12613000841774
Ethics application status
Approved
Date submitted
29/07/2013
Date registered
30/07/2013
Date last updated
30/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical evaluation of a novel olive leaf formulation for heart health.
Scientific title
A 12-week randomised, double-blind, placebo-controlled crossover trial to assess the antihypertensive potential of a novel dietary supplement (a combination of olive leaf extract, green coffee bean extract and beet powder) in borderline or mildly hypertensive but untreated adult volunteers.
Secondary ID [1] 282910 0
Nil
Universal Trial Number (UTN)
U1111-1145-9797
Trial acronym
OliveBP sudy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
24-hour ambulatory blood pressure 289724 0
Condition category
Condition code
Cardiovascular 290053 290053 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After screening for study eligibility, a baseline blood sample for analysis of lipids, glucose and insulin sensitivity will be obtained. Participants will then be asked to wear an ambulatory blood pressure monitor for 24 hours and to keep an activity diary to enable blood pressure values to be related to activities.

Participants will return the monitor and activity diary the following day (24 hours after screening) and will be randomly allocated to take one tablet of the active formulation (100mg of green coffee bean extract, 500mg of olive leaf extract, 150mg of beet powder) orally or a matching placebo in the morning and one table in the evening with main meals daily for 6 weeks. Participants will be required to write the time every time they consume a tablet in their supplement diary to serve as a reminder and to ensure compliance to study protocol.

At the end of 6 weeks, they will return to have their blood sample taken and the ambulatory blood pressure monitor fitted. Participants will return 24 hours later to return the monitor and activity diary and to receive their alternate treatment for a further 6 weeks, after which they will return for the final assessments.
Intervention code [1] 287608 0
Treatment: Other
Comparator / control treatment
Placebo (Cellulose, Microcrystalline, Calcium Hydrogen Phosphate, Magnesium Stearate and Silica, Colloidal Anhydrous)
Control group
Placebo

Outcomes
Primary outcome [1] 290104 0
24-hour ambulatory blood pressure, as measured using A&D Medical, TM-2430 Ambulatory Blood Pressure Monitor. An appropriately sized blood pressire cuff will be placed firmly around the upper non-dominant arm, centered over the brachial artery, with the monitor worn on a waist strap. Measurements will be recorded at 15 min intervals during the day (7am to 11 pm) and at 30 min intervals at night (11 pm – 7am). The same monitor, cuff size and arm will be used for ambulatory blood pressure monitoring on each occasion in each participant. Monitoring will be conducted for 24 hr
Timepoint [1] 290104 0
Baseline at week 0, and at week 6 and week 12 after intervention commencement.
Secondary outcome [1] 303959 0
HOMA-Index as determined by fasting serum glucose and insulin levels. Once the participants have met the study's blood pressure and body mass index criteria. They will be escorted to the Hunter Area Pathology Service (HAPS) collection centre at the John Hunter Hospital to provide a blood sample. Blood collection and biochemical analysis will be collected and provided Hunter Area Pathology Services (HAPS).
Timepoint [1] 303959 0
Baseline at week 0, and at week 6 and week 12 after intervention commencement.
Secondary outcome [2] 303960 0
Fasting total, HDL, LDL cholestrol and triglycerides. Once the participants have met the study's blood pressure and body mass index criteria. They will be escorted to the Hunter Area Pathology Service (HAPS) collection centre at the John Hunter Hospital to provide a blood sample. Blood collection and biochemical analysis will be collected and provided Hunter Area Pathology Services (HAPS).
Timepoint [2] 303960 0
Baseline at week 0, and at week 6 and week 12 after intervention commencement.
Secondary outcome [3] 303961 0
Seated clinic blood pressure and arterial compliance will be measured by automated oscillometry with a Cardiovascular Profiler (Trademark) (HDI Cardiovascular Profiler CR2000).
Timepoint [3] 303961 0
Baseline at week 0, and at week 6 and week 12 after intervention commencement.

Eligibility
Key inclusion criteria
Age 18 to 80 years
Body mass index between 20 and 35kg/m2 (determined at screening/baseline visit)
Systolic blood pressure (130-160mmHg) and/or diastolic blood pressure (85-100mmHg) (determined at screening/baseline visit)
Unlikely to change medication and/or supplementation during the study
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
A smoker or currently on nicotine therapy
Currently in antihypertensive medication
Currently on insulin therapy
Pregnant or currently breastfeeding
Unwilling to fast overnight before clinic visits
Unwilling to wear the ambulatory blood pressure monitor and have their blood pressure monitored for 24 hours
Unable to commit to the same time and day of the week for all 6 visits of the study
Unwilling to donate 15mL of blood sample at week 0 (baseline) and at week 6 and week 12 after intervention commencement.
Unwilling to maintain currently dietary and physical activity habits during the study.
Any conditions or medication or dietary supplement that in the opinion of the principal investigator may confound the results of the study.

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)
- Participants will receive and return a completed health and lifestyle questionnaire and consent form,
- Participants will then attend the research clinic for their screening/baseline visit.
- Those who meet the study's blood pressure and body mass index criteria will enter the trial and will undergo a blood sample and 24-hour ambulatory blood pressure monitoring assessment.
- Participant will be allocated to either active or inactive supplement for the first 6-week phase of the trial. The supplement bottles will be labelled with their assigned participant ID. Both the study investigator and the participant will not know whether they are on the ‘active’ or the ‘inactive’ supplement.
- After 6 weeks, participants will return for reassessment of the outcome measurements before crossing over to the alternate treatment in the second phase of the 6-week study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated their initial treatment accordingly to the randomisation by minimisation process (Altman & Bland BMJ 2005;330;843), where gender and body mass index will be the primary determinant. The initial allocation of the first participant will be determined by a coin toss.
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
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome is the mean within-subject difference in ABPM between the active and placebo treatments, assessed from averaged 24 hr, daytime and overnight measurements of SBP, DBP and mean arterial pressure (MAP) at the end of each 6 week treatment phase. Data will be tested for order effects. Assuming no order effect with the 2-way randomisation and no carry-over effect, the effect of treatment will be determined by paired t-test. This study is powered to detect changes with the olive leaf formulation. A total of 34 completers will give 80% power to detect a significant (P-value less than 0.05) change in blood pressure of at least of 3/2 mmHg (SBP/DBP). We will recruit 40 participants to allow for drop-outs.

Secondary outcomes (fasting plasma lipids, glucose, insulin sensitivity by HOMA) will be similarly tested but with a modified Bonferroni adjustment of significance levels for multiple comparisons. Effects of significant covariates, e.g. baseline BP, will be tested by ANCOVA.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/08/2013
Actual
2/09/2013
Date of last participant enrolment
Anticipated
Actual
27/09/2013
Date of last data collection
Anticipated
Actual
19/12/2013
Sample size
Target
40
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287691 0
Commercial sector/Industry
Name [1] 287691 0
HealthWorld Limited
Country [1] 287691 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
The University of Newcastle, University Drive, Callaghan, New South Wales 2308
Country
Australia
Secondary sponsor category [1] 286424 0
University
Name [1] 286424 0
Newcastle Innovation
Address [1] 286424 0
The University of Newcastle, University Drive, Callaghan, New South Wales 2308
Country [1] 286424 0
Australia
Other collaborator category [1] 277538 0
University
Name [1] 277538 0
Professor Peter Howe
Address [1] 277538 0
Clinical Nutrition Research Centre
School of Biomedical Sciences & Pharmacy
The University of Newcastle,
University Drive,
MS 304
Callaghan, NSW 2308
Country [1] 277538 0
Australia
Other collaborator category [2] 277539 0
University
Name [2] 277539 0
Professor Manohar Garg
Address [2] 277539 0
Nutraceuticals Research Group
305C Medical Science Building
University of Newcastle
University Drive,
Callaghan, NSW 2308
Country [2] 277539 0
Australia
Other collaborator category [3] 277540 0
University
Name [3] 277540 0
Associate Professor Lisa Wood
Address [3] 277540 0
Respiratory Medicine
Level 2 West Wing
Hunter Medical Research Institute Building
Kookaburra Circuit
New Lambton NSW 2305
Country [3] 277540 0
Australia
Other collaborator category [4] 277541 0
University
Name [4] 277541 0
Dr Rachel Wong
Address [4] 277541 0
Clinical Nutrition Research Centre
Hunter Medical Research Institute
Lot 1, Kookaburra Circuit
Level 4, Room 4604
New Lambton Heights NSW 2305
Country [4] 277541 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289652 0
Human Research Ethics Committee
Ethics committee address [1] 289652 0
Ethics committee country [1] 289652 0
Australia
Date submitted for ethics approval [1] 289652 0
Approval date [1] 289652 0
30/07/2013
Ethics approval number [1] 289652 0
H-2013-0131

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

Contacts
Principal investigator
Name 41762 0
Prof Peter Howe
Address 41762 0
Clinical Nutrition Research Centre
School of Biomedical Sciences & Pharmacy
MS 304
University of Newcastle
University Drive, Callaghan NSW 2308
Country 41762 0
Australia
Phone 41762 0
+61 2 4921 7309
Fax 41762 0
Email 41762 0
peter.howe@newcastle.edu.au
Contact person for public queries
Name 41763 0
Rachel Wong
Address 41763 0
Clinical Nutrition Research Centre Hunter Medical Research Institute Lot 1, Kookaburra Circuit, Level 3, New Lambton Heights NSW 2305
Country 41763 0
Australia
Phone 41763 0
+61 2 4042 3043
Fax 41763 0
Email 41763 0
rachel.wong@newcastle.edu.au
Contact person for scientific queries
Name 41764 0
Peter Howe
Address 41764 0
Clinical Nutrition Research Centre
School of Biomedical Sciences & Pharmacy
MS 304
University of Newcastle
University Drive, Callaghan NSW 2308
Country 41764 0
Australia
Phone 41764 0
+61 2 4921 7309
Fax 41764 0
Email 41764 0
peter.howe@newcastle.edu.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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