Olive Leaf Extract as Part of a Healthy Lifestyle in the Reduction of Blood Pressure

NCT ID: NCT02421835

Last Updated: 2016-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pre Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo control

2 capsules of 350 mg maltodextrin to be consumed daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

700 mg Maltodextrin per day

Olive leaf extract

2 capsules of 350 mg olive leaf extract equivalent 132 mg of oleuropein in olive leaf extract to be consumed daily for 12 weeks

Group Type ACTIVE_COMPARATOR

Olive leaf extract

Intervention Type DIETARY_SUPPLEMENT

132 mg of oleuropein per day suspended in olive leaf extract 700 mg

Physical activity

2 capsules of 350 mg maltodextrin to be consumed daily combined with gradually increase physical activity levels over 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

700 mg Maltodextrin per day

Physical activity and olive leaf extract

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

Group Type ACTIVE_COMPARATOR

Olive leaf extract

Intervention Type DIETARY_SUPPLEMENT

132 mg of oleuropein per day suspended in olive leaf extract 700 mg

Interventions

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Olive leaf extract

132 mg of oleuropein per day suspended in olive leaf extract 700 mg

Intervention Type DIETARY_SUPPLEMENT

Placebo

700 mg Maltodextrin per day

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Maltodextrin

Eligibility Criteria

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Inclusion Criteria

* 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
* 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

Exclusion Criteria

* 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
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Reading

OTHER

Sponsor Role lead

Responsible Party

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Jeremy Paul Edward Spencer

Olive Leaf Extract as Part of a Healthy Lifestyle in the Reduction of Blood Pressure

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Commane, PhD

Role: PRINCIPAL_INVESTIGATOR

Reading University

Locations

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Hugh Sinclair Unit of Human Nutrition

Reading, Berkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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OLE Chronic Study 2015

Identifier Type: -

Identifier Source: org_study_id