Effects of a combination of olive leaf extract and potassium on blood pressure in subjects with mild to moderate hypertension - a doubleblind, randomized, placebocontrolled study

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

•Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
•Sex: female and male (minimum 25% of each gender)
•Mild to moderate elevated blood pressure (systolic: 130-159 mmHg, during on site blood pressure measurement)
•BMI: 18.5 – 35 kg/m²
•Except elevated blood pressure, the subject is in good physical and mental health as established by medical history, physical examination, ECG, results of biochemistry, hematology
•Visit 1: Confirmed mild to moderate elevated blood pressure (systolic: 130-159 mmHg, during on site blood pressure measurement)

Exclusion Criteria

Main exclusion criteria:
•Relevant history or presence of any severe medical disorder, potentially interfering with this study (e.g. malabsorption, chronic gastro-intestinal diseases (e.g. Morbus Crohn, Colitis Ulcerosa), heavy depression, significant cardiovascular disease or co-morbidities (e.g. myocardial infarction, stroke, congestive heart failure), diabetes, acute malignant disease within last 3 years except basal cell carcinoma of the skin, etc.)
•Under medication which could affect blood pressure (including anti-hypertensive drugs) or stopped less than 3 months before randomization (e.g. Beta 2 agonists like salbutamol, Adrenergic agonists and antagonists, Angiotensin Converting Enzyme (ACE) inhibitors, Angiotensin receptor blockers, Calcium channel blockers, Beta-blockers, Thiazide diuretics, Direct renin inhibitors, Direct-acting vasodilators, etc)
•Intake of lipid lowering medication (e.g. statins, plant stanols, plant sterols etc.)
•Under dietary supplement which could have a direct influence on blood pressure in the month before screening (e.g. high dose L-arginine, high dose niacin, high dose omega-3 fatty acids, olive extracts, olive polyphenols, hydroxytyrosol, garlic extract / allicin, hawthorn etc.)
•Smoker >15 cigarettes / day

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure (OBP: office blood pressure measurement)

Secondary Outcome Measures

Name	Time	Method
•Diastolic blood pressure (OBP: office blood pressure measurement)<br>•Systolic and diastolic blood pressure (home based measurements)<br>•oxLDL<br>•Blood lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides)<br>•Glucose homeostasis (fasting glucose, Insulin, HOMA-index, HbA1c)<br>•Quality of life (SF-12)