Pre HypertensionNCT02421835
Olive Leaf Extract as Part of a Healthy Lifestyle in the Reduction of Blood Pressure
A study testing Olive leaf extract in people with Pre Hypertension, run by University of Reading at 1 site in United Kingdom.
Trial summary
Hypertension affects about 30% of the United Kingdom population and is causally implicated in the aetiology of renal disease, cardiovascular disease and stroke. Ageing, obesity, a poor diet and low levels of physical activity are all risk factors. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre Hypertension
- What is being tested?
- Olive leaf extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2013to Apr 2016
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women
- 25-70y
- BMI >25kg/m2
- Not having suffered a myocardial infarction/stroke in the past 12 months
- Not diabetic (diagnosed or fasting glucose > 7 mmol/l) or suffer from other endocrine disorders
- Not suffering from renal or bowel disease or have a history of cholestatic liver or pancreatitis
Show all 11Show fewer
- Not on drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation
- No history of alcohol misuse
- Not planning or on a weight reducing regime
- Not taking any fish oil, fatty acid or vitamin and mineral supplements
- Non smokers
Who cannot join
- Use of antibiotics within the previous 6 months
- History of alcohol or drug abuse
- Intake of any experimental drug within 4 weeks of the start of the study
- Excessive alcohol consumption (more than 21 units/wk male, 15 units/wk female)
- Females who are breast-feeding, may be pregnant, or of child-bearing potential and not using effective contraceptive precautions
- Have had recently (in the last 5 years) major surgery, which might limit participation in, or completion of, the study.
- On drug treatment for high blood fats, high blood pressure and blood clotting.
- Physical or mental diseases that are likely to limit participation or completion of the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hugh Sinclair Unit of Human Nutrition
Reading, Berkshire, RG6 6AP
About this study
Hypertension affects about 30% of the United Kingdom population and is causally implicated in the aetiology of renal disease, cardiovascular disease and stroke. Ageing, obesity, a poor diet and low levels of physical activity are all risk factors. Studies have shown that adherence to a Mediterranean diet is protective against hypertension and its associated morbidities; olive oil is believed to be a key beneficially bioactive component of that diet. As a source of lipids olive oil is an unremarkable blend of monounsaturated, polyunsaturated and saturated fatty acids; it is however rich in phenolic compounds, principally oleuropein and hydroxytyrosol, which may be of benefit to health. A recent randomised intervention trial in predominantly hypertensive volunteers showed that adherence to a Mediterranean diet supplemented with extra virgin olive oil, reduced blood pressure and other measures of cardiovascular disease risk. Olive phenolics can be extracted cheaply from the waste products of olive oil manufacture, such as the plant leaf and these are used as dietary supplements. In intervention studies in hypertensive or borderline hypertensive patients, olive leaf extract consumption has been shown to reduce blood pressure.
Another intervention with established efficacy for improving blood pressure is to increase physical activity. The 'Start Active, Stay Active', Chief Medical Officers report on physical activity recommends that adults achieve 150 minutes of moderate intensity physical activity per week, while data in that report suggest that fewer than 40% of adult men and 30% of adult women achieve these targets. Adherence to the physical activity guidelines may in fact be much worse in sub-sections of the population at higher risk of hypertension.
Read more
From a public health perspective, holistic guidelines for the prevention of hypertension, or its early diagnosis and management, based around a healthy diet and lifestyle are preferable to pharmaceutical intervention. Lifestyle interventions are economically favourable and they come with fewer side effects and perhaps wider health benefits than antihypertensive drugs.
The aim of the study is to evidence the synergistic benefits of consuming plant (and specifically olive) phenolics alongside achieving the recommended guidelines for physical activity in individuals with elevated blood pressure.
- Conditions
- Pre Hypertension
- Being tested
- Olive leaf extract, Placebo
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive leaf extractDietary supplement
132 mg of oleuropein per day suspended in olive leaf extract 700 mg
PlaceboDietary supplement
Also called Maltodextrin
700 mg Maltodextrin per day
| Study group | Role | What they receive |
|---|---|---|
| Placebo control | Placebo comparator | 2 capsules of 350 mg maltodextrin to be consumed daily for 12 weeks Receives: Dietary Supplement: Placebo |
| Olive leaf extract | Active comparator | 2 capsules of 350 mg olive leaf extract equivalent 132 mg of oleuropein in olive leaf extract to be consumed daily for 12 weeks Receives: Dietary Supplement: Olive leaf extract |
| Physical activity | Placebo comparator | 2 capsules of 350 mg maltodextrin to be consumed daily combined with gradually increase physical activity levels over 12 weeks Receives: Dietary Supplement: Placebo |
| Physical activity and olive leaf extract | Active comparator | 2 capsules of 350 mg olive leaf extract equivalent 132 mg of oleuropein in olive leaf extract to be consumed daily combined with gradually increase physical activity levels over 12 weeks Receives: Dietary Supplement: Olive leaf extract |
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 using the ScanMed Oscillometric Ambulatory blood pressure deviceVolunteers will be asked to wear the device which will be programmed to record BP measurements every 30 minutes during the day (7am-10pm) and every hour by night (10pm-7am)
Measured: 12 weeks
Secondary outcomes (7)
Average plasma glucose concentration
a measure of chronic blood sugar control) by measuring of glycated haemoglobin (HbA1c)
Measured: 12 weeks
Vascular function assessed by pulse wave velocity (PWV)
Measured: 12 weeks
Plasma biomarkers of endothelial function including nitric oxide, vascular cell adhesion molecule (VCAM), Inter-Cellular Adhesion Molecule (ICAM), E-selectin, von Willebrand factor
Measured: 12 weeks
Fasting lipid profile including measures of total, low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol, triglycerides and non-esterified fatty acids
Measured: 12 weeks
Indices of insulin resistance derived from fasted measures of glucose, insulin and non-esterified fatty acids (revised QUICKI statistical analysis)
Measured: 12 weeks
Haemostatic factors including Plasminogen activator inhibitor-1 (PAI-1)
Measured: 12 weeks
Inflammatory biomarkers including the acute phase proteins, C-reactive protein (CRP), tumour necrosis factor alpha (TNFα), Interleukin-6 (IL6)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startApr 2013
- Primary completionApr 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Paul Edward Spencer, University of Reading
- Investigators
- Daniel Commane, PhD, Principal investigator, Reading University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421835
- Sponsor's protocol ID
- OLE Chronic Study 2015
- Status last verified
- May 2016
- First submitted
- 10 Apr 2015
- Last updated
- 30 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olive Leaf Extract as Part of a Healthy Lifestyle in the Reduction of Blood Pressure
- ClinicalTrials.gov ID
- NCT02421835
- Acronym / sponsor ID
- OLE Chronic Study 2015
- Conditions
- Pre Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 21 Apr 2015 (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.
Hypertension affects about 30% of the United Kingdom population and is causally implicated in the aetiology of renal disease, cardiovascular disease and stroke. Ageing, obesity, a poor diet and low levels of physical activity are all risk factors. Studies have shown that adherence to a Mediterranean diet is protective against hypertension and its associated morbidities; olive oil is believed to be a key beneficially bioactive component of that diet. As a source of lipids olive oil is an unremarkable blend of monounsaturated, polyunsaturated and saturated fatty acids; it is however rich in phenolic compounds, principally oleuropein and hydroxytyrosol, which may be of benefit to health. A recent randomised intervention trial in predominantly hypertensive volunteers showed that adherence to a Mediterranean diet supplemented with extra virgin olive oil, reduced blood pressure and other measures of cardiovascular disease risk. Olive phenolics can be extracted cheaply from the waste products of olive oil manufacture, such as the plant leaf and these are used as dietary supplements. In intervention studies in hypertensive or borderline hypertensive patients, olive leaf extract consumption has been shown to reduce blood pressure.
Another intervention with established efficacy for improving blood pressure is to increase physical activity. The 'Start Active, Stay Active', Chief Medical Officers report on physical activity recommends that adults achieve 150 minutes of moderate intensity physical activity per week, while data in that report suggest that fewer than 40% of adult men and 30% of adult women achieve these targets. Adherence to the physical activity guidelines may in fact be much worse in sub-sections of the population at higher risk of hypertension.
From a public health perspective, holistic guidelines for the prevention of hypertension, or its early diagnosis and management, based around a healthy diet and lifestyle are preferable to pharmaceutical intervention. Lifestyle interventions are economically favourable and they come with fewer side effects and perhaps wider health benefits than antihypertensive drugs.
The aim of the study is to evidence the synergistic benefits of consuming plant (and specifically olive) phenolics alongside achieving the recommended guidelines for physical activity in individuals with elevated blood pressure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo control | Placebo comparator | Dietary Supplement: Placebo2 capsules of 350 mg maltodextrin to be consumed daily for 12 weeks |
| Olive leaf extract | Active comparator | Dietary Supplement: Olive leaf extract2 capsules of 350 mg olive leaf extract equivalent 132 mg of oleuropein in olive leaf extract to be consumed daily for 12 weeks |
| Physical activity | Placebo comparator | Dietary Supplement: Placebo2 capsules of 350 mg maltodextrin to be consumed daily combined with gradually increase physical activity levels over 12 weeks |
| Physical activity and olive leaf extract | Active comparator | Dietary Supplement: Olive leaf extract2 capsules of 350 mg olive leaf extract equivalent 132 mg of oleuropein in olive leaf extract to be consumed daily combined with gradually increase physical activity levels over 12 weeks |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men and women
- 25-70y
- BMI >25kg/m2
- Not having suffered a myocardial infarction/stroke in the past 12 months
- Not diabetic (diagnosed or fasting glucose > 7 mmol/l) or suffer from other endocrine disorders
Key exclusion criteria (8 listed)
- Use of antibiotics within the previous 6 months
- History of alcohol or drug abuse
- Intake of any experimental drug within 4 weeks of the start of the study
- Excessive alcohol consumption (more than 21 units/wk male, 15 units/wk female)
- Females who are breast-feeding, may be pregnant, or of child-bearing potential and not using effective contraceptive precautions
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 extract132 mg of oleuropein per day suspended in olive leaf extract 700 mg | Dietary supplement | Olive leaf extract, Physical activity and olive leaf extract |
| PlaceboAlso: Maltodextrin700 mg Maltodextrin per day | Dietary supplement | Physical activity, Placebo control |
Primary outcome
Blood pressure measured via 24 hour ambulatory blood pressure monitors
Time frame: 12 weeks
measured using the ScanMed Oscillometric Ambulatory blood pressure deviceVolunteers will be asked to wear the device which will be programmed to record BP measurements every 30 minutes during the day (7am-10pm) and every hour by night (10pm-7am)
7 secondary outcomes
Average plasma glucose concentration
Time frame: 12 weeks
Vascular function assessed by pulse wave velocity (PWV)
Time frame: 12 weeks
Plasma biomarkers of endothelial function including nitric oxide, vascular cell adhesion molecule (VCAM), Inter-Cellular Adhesion Molecule (ICAM), E-selectin, von Willebrand factor
Time frame: 12 weeks
Fasting lipid profile including measures of total, low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol, triglycerides and non-esterified fatty acids
Time frame: 12 weeks
Indices of insulin resistance derived from fasted measures of glucose, insulin and non-esterified fatty acids (revised QUICKI statistical analysis)
Time frame: 12 weeks
Haemostatic factors including Plasminogen activator inhibitor-1 (PAI-1)
Time frame: 12 weeks
Inflammatory biomarkers including the acute phase proteins, C-reactive protein (CRP), tumour necrosis factor alpha (TNFα), Interleukin-6 (IL6)
Time frame: 12 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 30 May 2016.
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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.
Daniel Commane, PhD principal investigator
Reading 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 in people with Pre Hypertension, run by University of Reading at 1 site in United Kingdom.
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 11 inclusion and 8 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 30 May 2016. 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 United Kingdom. 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: 12 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 30 May 2016.