Hypertension, SystolicPhase 4NCT04874961
Olive Polyphenols in Cardiovascular Prevention
A Phase 4 study testing Tensiofytol® in people with Hypertension, Systolic, run by Nina Hermans at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Hypertension, Systolic
- What is being tested?
- Tensiofytol®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteBelgium
- Study dates
- 20 May 2021to 21 May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systolic blood pressure ≥ 130 mmHg
Who cannot join
- <18 jaar
- >76 jaar
- Smoking
- Use of nutritional supplements or (chronic) medication*
- Triglycerides > 400 mg/dL
- > 14 alcoholic consumptions/week
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Olive Polyphenols in Cardiovascular Prevention: Efficacy and Tolerability of a Commercially Available Standardized Olive Extract (Tensiofytol®) as Compared to Placebo in Patients With Elevated Blood Pressure: a RDBPC Trial.
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
- Leads to a clinically relevant reduction of blood pressure on the short term,
- Leads to a clinically relevant reduction of cholesterol levels, especially LDL,
- Leads to a change in oxidative stress biomarkers.
Read more
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.
- Conditions
- Hypertension, Systolic
- Being tested
- Tensiofytol®, Placebo
- Medical subject headings
- Isolated Systolic Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tensiofytol®Dietary supplement
standardized olive extract
PlaceboOther
contains excipients only
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Tensiofytol® |
| Placebo | Placebo comparator | 3 capsules/day during dinner Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Blood Pressure, Systolic at 8 weeks
average of 3 measurements during 15 minutes
Measured: Baseline, 8 weeks
Secondary outcomes (15)
Frequency of side effects (+ their burden) as reported in the final questionnaire
Unvalidated but standardized questionnaire on typical statin-related side effects
Measured: 8 weeks
Change from baseline Blood Pressure, diastolic at 8 weeks
average of 3 measurements during 15 minutes
Measured: Baseline, 8 weeks
Change from baseline Blood Pressure, systolic at 4 weeks
average of 3 measurements during 15 minutes
Measured: Baseline, 4 weeks
Change from baseline LDL cholesterol level at 8 weeks
Calculated from Total Cholesterol, HDL Cholesterol and Triglycerides
Measured: Baseline, 8 weeks
Change from baseline HDL cholesterol level at 8 weeks
Measurement in Serum
Measured: Baseline, 8 weeks
Change from baseline non-HDL cholesterol level at 8 weeks
Calculated from HDL and total cholesterol
Measured: Baseline, 8 weeks
Change from baseline total cholesterol level at 8 weeks
Measurement in Serum
Measured: Baseline, 8 weeks
Change from baseline triglycerides level at 8 weeks
Measurement in Serum
Measured: Baseline, 8 weeks
Change from baseline Apo A1 level at 8 weeks
Measurement in Serum
Measured: Baseline, 8 weeks
Change from baseline Apo B level at 8 weeks
Measurement in Serum
Measured: Baseline, 8 weeks
Change from baseline lipoprotein A (LP(a)) level at 8 weeks
Measurement in Serum
Measured: Baseline, 8 weeks
Change from baseline OxLDL level at 8 weeks
Measurement with ELISA
Measured: Baseline, 8 weeks
Change from baseline gluathion (GSH) level at 8 weeks
Measurement with in house HPLC method
Measured: Baseline, 8 weeks
Change from baseline malondialdehyde (MDA) level at 8 weeks
Measurement with ELISA
Measured: Baseline, 8 weeks
Change from baseline Remnant Cholesterol at 8 weeks
Calculated from total, HDL and LDL cholesterol
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start20 May 2021
- Primary completion21 May 2024
- Study completion21 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension, SystolicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nina Hermans
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp
- Responsible party
- Sponsor-investigator, Nina Hermans, Universiteit Antwerpen
- Investigators
- Johan Bosmans, Prof. MD., Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874961
- Sponsor's protocol ID
- Olijfstudie 2021
- Status last verified
- Jan 2024
- First submitted
- 27 Apr 2021
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41805711
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olive Polyphenols in Cardiovascular Prevention: Efficacy and Tolerability of a Commercially Available Standardized Olive Extract (Tensiofytol®) as Compared to Placebo in Patients With Elevated Blood Pressure: a RDBPC Trial.
- ClinicalTrials.gov ID
- NCT04874961
- Acronym / sponsor ID
- Olijfstudie 2021
- Conditions
- Hypertension, Systolic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Nina HermansUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp
- Study start
- 20 May 2021 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Leads to a clinically relevant reduction of blood pressure on the short term,
- Leads to a clinically relevant reduction of cholesterol levels, especially LDL,
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized olive extract (Tensiofytol®) | Experimental | Dietary Supplement: Tensiofytol®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 | Other: Placebo3 capsules/day during dinner |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Systolic blood pressure ≥ 130 mmHg
Key exclusion criteria (12 listed)
- <18 jaar
- >76 jaar
- Smoking
- Use of nutritional supplements or (chronic) medication*
- Triglycerides > 400 mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tensiofytol®standardized olive extract | Dietary supplement | Standardized olive extract (Tensiofytol®) |
| Placebocontains excipients only | Other | Placebo |
Primary outcome
Change from baseline Blood Pressure, Systolic at 8 weeks
Time frame: Baseline, 8 weeks
average of 3 measurements during 15 minutes
15 secondary outcomes
Frequency of side effects (+ their burden) as reported in the final questionnaire
Time frame: 8 weeks
Change from baseline Blood Pressure, diastolic at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline Blood Pressure, systolic at 4 weeks
Time frame: Baseline, 4 weeks
Change from baseline LDL cholesterol level at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline HDL cholesterol level at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline non-HDL cholesterol level at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline total cholesterol level at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline triglycerides level at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline Apo A1 level at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline Apo B level at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline lipoprotein A (LP(a)) level at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline OxLDL level at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline gluathion (GSH) level at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline malondialdehyde (MDA) level at 8 weeks
Time frame: Baseline, 8 weeks
Change from baseline Remnant Cholesterol at 8 weeks
Time frame: Baseline, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Derived from this study: PubMed 41805711Lauwers 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Bosmans, Prof. MD. principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tensiofytol® in people with Hypertension, Systolic, run by Nina Hermans at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Blood Pressure, Systolic at 8 weeks (time frame: Baseline, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04874961, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.