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

NCT02421835 | Completed DMC

• 1 other identifier: OLE Chronic Study 2015
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Average plasma glucose concentration

  12 weeks

• Vascular function assessed by pulse wave velocity (PWV)

  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

  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

  12 weeks

• Indices of insulin resistance derived from fasted measures of glucose, insulin and non-esterified fatty acids (revised QUICKI statistical analysis)

  12 weeks

Study Arms (4)

Placebo control

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Olive leaf extract

ACTIVE COMPARATOR

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

Dietary Supplement: Olive leaf extract

Physical activity

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Physical activity and olive leaf extract

ACTIVE COMPARATOR

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

Dietary Supplement: Olive leaf extract

Interventions

Olive leaf extract DIETARY_SUPPLEMENT

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

Olive leaf extract; Physical activity and olive leaf extract

Placebo DIETARY_SUPPLEMENT

700 mg Maltodextrin per day

Also known as: Maltodextrin

Physical activity; Placebo control

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Reading: lead

Study Sites (1)

Hugh Sinclair Unit of Human Nutrition

Reading, Berkshire, RG6 6AP, United Kingdom

Location

MeSH Terms

Conditions

Prehypertension

Interventions

olive leaf extract; maltodextrin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Daniel Commane, PhD

  Reading University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Olive Leaf Extract as Part of a Healthy Lifestyle in the Reduction of Blood Pressure

Study Record Dates

• First Submitted: April 10, 2015
• First Posted: April 21, 2015
• Study Start: April 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2016
• Last Updated: May 30, 2016

Record last verified: 2016-05

Locations

GB (1)