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| Name | Class |
|---|---|
| University Hospital, Antwerp | OTHER |
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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
Participants will be stratified by sex before randomization to one of the three treatments for 8 weeks:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standardized olive extract (Tensiofytol®) | Experimental | 3 capsules/day during dinner Per day: 334 mg olive leave dry extract and 106 mg olive fruit dry extract (Olea europaea L.), equivalent to 100 mg oleuropein and 20 mg hydroxytyrosol |
|
| Placebo | Placebo Comparator | 3 capsules/day during dinner |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tensiofytol® | Dietary Supplement | standardized olive extract |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Blood Pressure, Systolic at 8 weeks | average of 3 measurements during 15 minutes | Baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of side effects (+ their burden) as reported in the final questionnaire | Unvalidated but standardized questionnaire on typical statin-related side effects | 8 weeks |
| Change from baseline Blood Pressure, diastolic at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline insuline level at 8 weeks | Required to correctly interpret glucose levels, Measurement in Serum | Baseline, 8 weeks |
| Change from baseline homocysteine level at 8 weeks | Measurement in Homocysteine Serum |
Inclusion Criteria:
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
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.
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| Name | Affiliation | Role |
|---|---|---|
| Johan Bosmans, Prof. MD. | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAntwerp, NatuRAPT | Wilrijk | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41805711 | Derived | Lauwers S, Breynaert A, Verlaet A, Fransen E, Bringmans T, Roth L, Tuenter E, Bosmans J, Hermans N. Evaluation of the effect of olive extracts on blood pressure and cardiovascular health markers in adults: Findings from a double-blind, placebo-controlled, randomised trial. PLoS One. 2026 Mar 10;21(3):e0344278. doi: 10.1371/journal.pone.0344278. eCollection 2026. |
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| ID | Term |
|---|---|
| D000092244 | Isolated Systolic Hypertension |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo |
| Other |
contains excipients only |
|
average of 3 measurements during 15 minutes
| Baseline, 8 weeks |
| Change from baseline Blood Pressure, systolic at 4 weeks | average of 3 measurements during 15 minutes | Baseline, 4 weeks |
| Change from baseline LDL cholesterol level at 8 weeks | Calculated from Total Cholesterol, HDL Cholesterol and Triglycerides | Baseline, 8 weeks |
| Change from baseline HDL cholesterol level at 8 weeks | Measurement in Serum | Baseline, 8 weeks |
| Change from baseline non-HDL cholesterol level at 8 weeks | Calculated from HDL and total cholesterol | Baseline, 8 weeks |
| Change from baseline total cholesterol level at 8 weeks | Measurement in Serum | Baseline, 8 weeks |
| Change from baseline triglycerides level at 8 weeks | Measurement in Serum | Baseline, 8 weeks |
| Change from baseline Apo A1 level at 8 weeks | Measurement in Serum | Baseline, 8 weeks |
| Change from baseline Apo B level at 8 weeks | Measurement in Serum | Baseline, 8 weeks |
| Change from baseline lipoprotein A (LP(a)) level at 8 weeks | Measurement in Serum | Baseline, 8 weeks |
| Change from baseline OxLDL level at 8 weeks | Measurement with ELISA | Baseline, 8 weeks |
| Change from baseline gluathion (GSH) level at 8 weeks | Measurement with in house HPLC method | Baseline, 8 weeks |
| Change from baseline malondialdehyde (MDA) level at 8 weeks | Measurement with ELISA | Baseline, 8 weeks |
| Change from baseline Remnant Cholesterol at 8 weeks | Calculated from total, HDL and LDL cholesterol | Baseline, 8 weeks |
| Baseline, 8 weeks |
| Change from baseline hs-CRP level at 8 weeks | Measurement in Serum | Baseline, 8 weeks |
| Change from baseline creatinine level at 8 weeks | Required to correctly interpret HbAc1 levels, Measurement in Serum | Baseline, 8 weeks |
| Change from baseline HbA1c level at 8 weeks | Measurement in EDTA Whole Blood | Baseline, 8 weeks |
| Change from baseline hemoglobine level at 8 weeks | Required to correctly interpret HbAc1 levels, Measurement in EDTA Whole Blood | Baseline, 8 weeks |
| Change from baseline creatine kinase (CK) level at 8 weeks | Measurement in serum | Baseline, 8 weeks |
| Change from baseline C-peptide level at 8 weeks | Measurement in serum | Baseline, 8 weeks |
| Change from baseline waist circumference at 8 weeks | Measurement with measuring tape | Baseline, 8 weeks |
| Change from baseline Body Mass Index (BMI) at 8 weeks | weight and height will be combined to report BMI in kg/m^2 | Baseline, 8 weeks |
| Change from baseline glucose level at 8 weeks | Measurement in Fluoride Plasma | Baseline, 8 weeks |