Mild to moderately elevated blood pressure (high normal and hypertension grade 1)
Conditions
Interventions
Group 1: 1000 mg olive leaf extract and 300 mg potassium (daily dose)
Group 2: Placebo
Sponsors
APOMEDICA Pharmazeutische Produkte GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systolic blood pressure (OBP: office blood pressure measurement) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Diastolic blood pressure (OBP: office blood pressure measurement) • Systolic and diastolic blood pressure (home based measurements) • oxLDL • Blood lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) • Glucose homeostasis (fasting glucose, Insulin, HOMA-index, HbA1c) • Quality of life (SF-12) | — |
Countries
Germany
Contacts
Public ContactChristiane Schön
BioTeSys GmbH
Outcome results
None listed