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

Pre Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02421835
• Other study ID #: OLE Chronic Study 2015
• Status: Completed
• Phase: N/A
• First received: April 10, 2015
• Last updated: May 27, 2016
• Start date: April 2013
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pre Hypertension
• Prehypertension

Intervention

Dietary Supplement:
• Olive leaf extract
132 mg of oleuropein per day suspended in olive leaf extract 700 mg
• Placebo
700 mg Maltodextrin per day

Locations

Country	Name	City	State
United Kingdom	Hugh Sinclair Unit of Human Nutrition	Reading	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	12 weeks	No
Secondary	Average plasma glucose concentration	a measure of chronic blood sugar control) by measuring of glycated haemoglobin (HbA1c)	12 weeks	No
Secondary	Vascular function assessed by pulse wave velocity (PWV)		12 weeks	No
Secondary	Plasma biomarkers of endothelial function including nitric oxide, vascular cell adhesion molecule (VCAM), Inter-Cellular Adhesion Molecule (ICAM), E-selectin, von Willebrand factor		12 weeks	No
Secondary	Fasting lipid profile including measures of total, low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol, triglycerides and non-esterified fatty acids		12 weeks	No
Secondary	Indices of insulin resistance derived from fasted measures of glucose, insulin and non-esterified fatty acids (revised QUICKI statistical analysis)		12 weeks	No
Secondary	Haemostatic factors including Plasminogen activator inhibitor-1 (PAI-1)		12 weeks	No
Secondary	Inflammatory biomarkers including the acute phase proteins, C-reactive protein (CRP), tumour necrosis factor alpha (TNFa), Interleukin-6 (IL6)		12 weeks	No