HypertensionNCT01796561
The Effect of Olive Leaf Extract on Blood Pressure in Overweight Prehypertensives
A study testing Olive leaf extract liquid in people with Hypertension, run by University of Reading at 1 site in New Zealand.
Trial summary
Cardiovascular disease (CVD) is the leading cause of death in New Zealand (40% of all deaths). 37% of New Zealanders suffer from high blood pressure (World Health Organisation 2008 figures), a well established modifiable risk factor for CVD. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Olive leaf extract liquid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteNew Zealand
- Study dates
- Feb 2013to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men 18-65 years; Non-smokers; Prepared to consume olive leaf extract liquid Systolic blood pressure 121-139 mmHg and diastolic blood pressure 81-89 mmHg Body mass index (BMI) between 25-30 kg/m2 or waist >102 cm
Who cannot join
- Smokers Using blood pressure, lipid lowering, thyroid disorder, blood clotting medication Using supplements or functional foods that will affect lipid concentrations (e.g. sterol enriched spreads) Chronic disease e.g. CHD, diabetes, cancer, digestive disorders Individuals who are unwilling to refrain from consuming olive containing products for the duration of the study
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
Institute of Food, Nutrition and Human Health, Massey University
Albany, North Shore, Auckland, 0745
About this study
Official title: Effect of Chronic Polyphenol-rich Olive Leaf Extract Intake on Cardiovascular Risk Markers
Cardiovascular disease (CVD) is the leading cause of death in New Zealand (40% of all deaths). 37% of New Zealanders suffer from high blood pressure (World Health Organisation 2008 figures), a well established modifiable risk factor for CVD. Above 115/75 mmHg, CVD risk doubles for each increment of 20/10 mmHg that blood pressure is raised. An increase in BMI and waist circumference has been associated with an increase in blood pressure. The leaves of the olive plant are rich in plant compounds known as polyphenols. This particular group of polyphenols are known secoiridoids, which are also present in olive oil and olives though at lower concentrations, are only found in this family of plants. Diets high in polyphenols have been found to reduce the risk of chronic diseases. Studies have shown that consumption of phenolic-rich olive leaf extract (OLE) can significantly reduce blood pressure in individuals suffering from high blood pressure (hypertension), with the magnitude of effect being comparable to a commonly used antihypertensive drug. In such trials OLE also resulted in an improved blood lipid (a reduction in total and LDL cholesterol and triacylglycerides) which also reduces CVD risk. One study testing the effect of OLE on individuals with mild or prehypertension (i.e. those with systolic blood pressure in the range 121-139 mmHg and diastolic blood pressure in the range 81-89 mmHg but not taking antihypertensive medication) also found these same improvements. OLE has been indicated to have the potential to improve other cardiovascular risk markers such as vascular function, inflammation, platelet aggregation, oxidation of LDL and glucose tolerance however much of this evidence is derived from animal, in vitro and ex vivo studies and so well designed and controlled human studies are required to verify that these findings are applicable to humans. Therefore OLE supplementation may be a useful dietary strategy for reducing CVD risk in a cohort of overweight prehypertensive individuals.
The aim of the study is to determine the effect of OLE intake on blood pressure and other CVD risk markers in overweight subjects with mild hypertension and to link any study outcomes with the presence of OLE phenolics in urine
- Conditions
- Hypertension
- Being tested
- Olive leaf extract liquid
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive leaf extract liquidDietary supplement
Commercially available polyphenol-rich olive leaf extract liquid
| Study group | Role | What they receive |
|---|---|---|
| Olive leaf extract liquid | Active comparator | 20ml of polyphenol-rich olive leaf extract liquid to be consumed daily for 6 weeks Receives: Dietary Supplement: Olive leaf extract liquid |
| Placebo liquid | Placebo comparator | 20ml of polyphenol-free placebo liquid (containing water, glycerin, flavours, colours and aromas) to be consumed daily for 6 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure measured via 24 hour ambulatory blood pressure monitors
Measured: 6 weeks
Secondary outcomes (10)
Vascular function assessed by pulse wave velocity (PWV)
Measured: 6 weeks
Lipid profile measured via serum assay
Measured: 6 weeks
Inflammatory cytokines measured via plasma assay
Measured: 6 weeks
Fructosamine measured via plasma assay
Measured: 6 weeks
Glucose measured via plasma assay
Measured: 6 weeks
Nitric oxide measured via plasma assay
Measured: 6 weeks
Insulin measured via plasma assay
Measured: 6 weeks
Haemostatic factors (D-dimer, PAI-1 ag, von Willebrand factor, prothrombin F1+2, factor VIII) measured via plasma assay
Measured: 6 weeks
Oxidised LDL measured via plasma assay
Measured: 6 weeks
Obesity markers (adiponectin, CCL-2, complement factor D, CRP, IL-6, IL-10, leptin, resistin, serpin E1 and TNF-a) measured via plasma assay
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Massey University
- Responsible party
- Principal investigator, Jeremy Paul Edward Spencer, University of Reading
- Investigators
- Welma Stonehouse, PhD, Principal investigator, Massey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796561
- Sponsor's protocol ID
- OLE chronic study
- Status last verified
- Oct 2013
- First submitted
- 20 Feb 2013
- Last updated
- 11 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chronic Polyphenol-rich Olive Leaf Extract Intake on Cardiovascular Risk Markers
- ClinicalTrials.gov ID
- NCT01796561
- Acronym / sponsor ID
- OLE chronic study
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Massey University
- Study start
- Feb 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 21 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiovascular disease (CVD) is the leading cause of death in New Zealand (40% of all deaths). 37% of New Zealanders suffer from high blood pressure (World Health Organisation 2008 figures), a well established modifiable risk factor for CVD. Above 115/75 mmHg, CVD risk doubles for each increment of 20/10 mmHg that blood pressure is raised. An increase in BMI and waist circumference has been associated with an increase in blood pressure. The leaves of the olive plant are rich in plant compounds known as polyphenols. This particular group of polyphenols are known secoiridoids, which are also present in olive oil and olives though at lower concentrations, are only found in this family of plants. Diets high in polyphenols have been found to reduce the risk of chronic diseases. Studies have shown that consumption of phenolic-rich olive leaf extract (OLE) can significantly reduce blood pressure in individuals suffering from high blood pressure (hypertension), with the magnitude of effect being comparable to a commonly used antihypertensive drug. In such trials OLE also resulted in an improved blood lipid (a reduction in total and LDL cholesterol and triacylglycerides) which also reduces CVD risk. One study testing the effect of OLE on individuals with mild or prehypertension (i.e. those with systolic blood pressure in the range 121-139 mmHg and diastolic blood pressure in the range 81-89 mmHg but not taking antihypertensive medication) also found these same improvements. OLE has been indicated to have the potential to improve other cardiovascular risk markers such as vascular function, inflammation, platelet aggregation, oxidation of LDL and glucose tolerance however much of this evidence is derived from animal, in vitro and ex vivo studies and so well designed and controlled human studies are required to verify that these findings are applicable to humans. Therefore OLE supplementation may be a useful dietary strategy for reducing CVD risk in a cohort of overweight prehypertensive individuals.
The aim of the study is to determine the effect of OLE intake on blood pressure and other CVD risk markers in overweight subjects with mild hypertension and to link any study outcomes with the presence of OLE phenolics in urine
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olive leaf extract liquid | Active comparator | Dietary Supplement: Olive leaf extract liquid20ml of polyphenol-rich olive leaf extract liquid to be consumed daily for 6 weeks |
| Placebo liquid | Placebo comparator | –20ml of polyphenol-free placebo liquid (containing water, glycerin, flavours, colours and aromas) to be consumed daily for 6 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men 18-65 years; Non-smokers; Prepared to consume olive leaf extract liquid Systolic blood pressure 121-139 mmHg and diastolic blood pressure 81-89 mmHg Body mass index (BMI) between 25-30 kg/m2 or waist >102 cm
Key exclusion criteria (1 listed)
- Smokers Using blood pressure, lipid lowering, thyroid disorder, blood clotting medication Using supplements or functional foods that will affect lipid concentrations (e.g. sterol enriched spreads) Chronic disease e.g. CHD, diabetes, cancer, digestive disorders Individuals who are unwilling to refrain from consuming olive containing products for the duration of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olive leaf extract liquidCommercially available polyphenol-rich olive leaf extract liquid | Dietary supplement | Olive leaf extract liquid |
Primary outcome
Blood pressure measured via 24 hour ambulatory blood pressure monitors
Time frame: 6 weeks
10 secondary outcomes
Vascular function assessed by pulse wave velocity (PWV)
Time frame: 6 weeks
Lipid profile measured via serum assay
Time frame: 6 weeks
Inflammatory cytokines measured via plasma assay
Time frame: 6 weeks
Fructosamine measured via plasma assay
Time frame: 6 weeks
Glucose measured via plasma assay
Time frame: 6 weeks
Nitric oxide measured via plasma assay
Time frame: 6 weeks
Insulin measured via plasma assay
Time frame: 6 weeks
Haemostatic factors (D-dimer, PAI-1 ag, von Willebrand factor, prothrombin F1+2, factor VIII) measured via plasma assay
Time frame: 6 weeks
Oxidised LDL measured via plasma assay
Time frame: 6 weeks
Obesity markers (adiponectin, CCL-2, complement factor D, CRP, IL-6, IL-10, leptin, resistin, serpin E1 and TNF-a) measured via plasma assay
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Welma Stonehouse, PhD principal investigator
Massey University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olive leaf extract liquid in people with Hypertension, run by University of Reading at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure measured via 24 hour ambulatory blood pressure monitors (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2013.