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
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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COMPLETED
NA
120 participants
INTERVENTIONAL
2013-04-30
2016-04-30
Brief Summary
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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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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo control
2 capsules of 350 mg maltodextrin to be consumed daily for 12 weeks
Placebo
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
Olive leaf extract
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
Placebo
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
Olive leaf extract
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
Placebo
700 mg Maltodextrin per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
25 Years
70 Years
ALL
Yes
Sponsors
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University of Reading
OTHER
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
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
Countries
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Other Identifiers
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OLE Chronic Study 2015
Identifier Type: -
Identifier Source: org_study_id