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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 o

Detailed Summary:
Sponsor: University of Reading

Current 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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: University of Reading

Dates:
Date Received: April 10, 2015
Date Started: April 2013
Date Completion:
Last Updated: May 27, 2016
Last Verified: May 2016