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

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ClinicalTrials.gov Identifier: NCT02421835
Recruitment Status : Completed
First Posted : April 21, 2015
Last Update Posted : May 30, 2016
Sponsor:
Information provided by (Responsible Party):
Jeremy Paul Edward Spencer, University of Reading

Tracking Information
First Submitted Date  ICMJE April 10, 2015
First Posted Date  ICMJE April 21, 2015
Last Update Posted Date May 30, 2016
Study Start Date  ICMJE April 2013
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2015)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2015)
  • Average plasma glucose concentration [ Time Frame: 12 weeks ]
    a measure of chronic blood sugar control) by measuring of glycated haemoglobin (HbA1c)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Olive Leaf Extract as Part of a Healthy Lifestyle in the Reduction of Blood Pressure
Official Title  ICMJE Olive Leaf Extract as Part of a Healthy Lifestyle in the Reduction of Blood Pressure
Brief 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. 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pre Hypertension
Intervention  ICMJE
  • Dietary Supplement: Olive leaf extract
    132 mg of oleuropein per day suspended in olive leaf extract 700 mg
  • Dietary Supplement: Placebo
    700 mg Maltodextrin per day
    Other Name: Maltodextrin
Study Arms  ICMJE
  • Placebo Comparator: Placebo control
    2 capsules of 350 mg maltodextrin to be consumed daily for 12 weeks
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: 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
    Intervention: Dietary Supplement: Olive leaf extract
  • Placebo Comparator: Physical activity
    2 capsules of 350 mg maltodextrin to be consumed daily combined with gradually increase physical activity levels over 12 weeks
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: 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
    Intervention: Dietary Supplement: Olive leaf extract
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2015)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02421835
Other Study ID Numbers  ICMJE OLE Chronic Study 2015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeremy Paul Edward Spencer, University of Reading
Study Sponsor  ICMJE University of Reading
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel Commane, PhD Reading University
PRS Account University of Reading
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP