Hypertension, Systolic
Conditions
Brief summary
The aim of this study is to evaluate whether the use of a commercially available standardized olive extract (Tensiofytol®) in individuals with elevated blood pressure 1. Leads to a clinically relevant reduction of blood pressure on the short term, 2. Leads to a clinically relevant reduction of cholesterol levels, especially LDL, 3. Leads to a change in oxidative stress biomarkers. Participants will be stratified by sex before randomization to one of the three treatments for 8 weeks: * Tensiofytol: 100 mg oleuropein and 20 mg hydroxytyrosol per day * Placebo All treatments have an identical shape and color and should be used in the same way (oral intake; 3 capsules/day during dinner). No dietary instructions are given and participants are asked not to change their dietary habits, nor to start other therapies (medication, supplements, slimming diets, extra physical activity, etc.) during their study period. Standardized questionnaires are used to obtain information on demographics, dietary habits and side effects. At baseline and after 8 weeks, 27 ml blood is drawn for various biological analyses, and blood pressure, BMI and waist circumference are measured.
Interventions
DIETARY_SUPPLEMENTTensiofytol®
standardized olive extract
OTHERPlacebo
contains excipients only
Sponsors
University Hospital, Antwerp
Nina Hermans
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 76 Years
Healthy volunteers
No
Inclusion criteria
* Systolic blood pressure ≥ 130 mmHg
Exclusion criteria
* \<18 jaar * \>76 jaar * Smoking * Use of nutritional supplements or (chronic) medication\* * Triglycerides \> 400 mg/dL * \> 14 alcoholic consumptions/week * Chronic illness (e.g. diabetes, atherosclerosis, reumatoid arthritis) * Acute infection * Current pregnancy or pregnancy wish during the study period * Breast feeding * When nutritional supplements were used regularly, participation is allowed after a 10-day wash out period. Use of medication will be individually assessed and is permitted if it does not interfere with the used treatments and the patient is stable on the medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Blood Pressure, Systolic at 8 weeks | Baseline, 8 weeks | average of 3 measurements during 15 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Blood Pressure, systolic at 4 weeks | Baseline, 4 weeks | average of 3 measurements during 15 minutes |
| Change from baseline HDL cholesterol level at 8 weeks | Baseline, 8 weeks | Measurement in Serum |
| Change from baseline non-HDL cholesterol level at 8 weeks | Baseline, 8 weeks | Calculated from HDL and total cholesterol |
| Change from baseline total cholesterol level at 8 weeks | Baseline, 8 weeks | Measurement in Serum |
| Change from baseline triglycerides level at 8 weeks | Baseline, 8 weeks | Measurement in Serum |
| Change from baseline Apo A1 level at 8 weeks | Baseline, 8 weeks | Measurement in Serum |
| Change from baseline Apo B level at 8 weeks | Baseline, 8 weeks | Measurement in Serum |
| Change from baseline lipoprotein A (LP(a)) level at 8 weeks | Baseline, 8 weeks | Measurement in Serum |
| Change from baseline OxLDL level at 8 weeks | Baseline, 8 weeks | Measurement with ELISA |
| Change from baseline gluathion (GSH) level at 8 weeks | Baseline, 8 weeks | Measurement with in house HPLC method |
| Change from baseline malondialdehyde (MDA) level at 8 weeks | Baseline, 8 weeks | Measurement with ELISA |
| Change from baseline Remnant Cholesterol at 8 weeks | Baseline, 8 weeks | Calculated from total, HDL and LDL cholesterol |
| Frequency of side effects (+ their burden) as reported in the final questionnaire | 8 weeks | Unvalidated but standardized questionnaire on typical statin-related side effects |
| Change from baseline Blood Pressure, diastolic at 8 weeks | Baseline, 8 weeks | average of 3 measurements during 15 minutes |
| Change from baseline LDL cholesterol level at 8 weeks | Baseline, 8 weeks | Calculated from Total Cholesterol, HDL Cholesterol and Triglycerides |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline hs-CRP level at 8 weeks | Baseline, 8 weeks | Measurement in Serum |
| Change from baseline creatinine level at 8 weeks | Baseline, 8 weeks | Required to correctly interpret HbAc1 levels, Measurement in Serum |
| Change from baseline HbA1c level at 8 weeks | Baseline, 8 weeks | Measurement in EDTA Whole Blood |
| Change from baseline hemoglobine level at 8 weeks | Baseline, 8 weeks | Required to correctly interpret HbAc1 levels, Measurement in EDTA Whole Blood |
| Change from baseline creatine kinase (CK) level at 8 weeks | Baseline, 8 weeks | Measurement in serum |
| Change from baseline C-peptide level at 8 weeks | Baseline, 8 weeks | Measurement in serum |
| Change from baseline waist circumference at 8 weeks | Baseline, 8 weeks | Measurement with measuring tape |
| Change from baseline Body Mass Index (BMI) at 8 weeks | Baseline, 8 weeks | weight and height will be combined to report BMI in kg/m\^2 |
| Change from baseline glucose level at 8 weeks | Baseline, 8 weeks | Measurement in Fluoride Plasma |
| Change from baseline insuline level at 8 weeks | Baseline, 8 weeks | Required to correctly interpret glucose levels, Measurement in Serum |
| Change from baseline homocysteine level at 8 weeks | Baseline, 8 weeks | Measurement in Homocysteine Serum |
Countries
Belgium
Outcome results
None listed