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Completed

NCT Number: NCT04874961

Olive Polyphenols in Cardiovascular Prevention

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.

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Key information

Conditions

Hypertension, Systolic Cardiovascular Diseases Essential Hypertension Hypertension Isolated Systolic Hypertension Vascular Diseases

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UAntwerp, NatuRAPT

Wilrijk, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tensiofytol®

Dietary Supplement

standardized olive extract

Placebo

Other

contains excipients only

Primary outcomes

  1. Change from baseline Blood Pressure, Systolic at 8 weeks

    Time frame: Baseline, 8 weeks

    average of 3 measurements during 15 minutes

Secondary outcomes

  1. Frequency of side effects (+ their burden) as reported in the final questionnaire

    Time frame: 8 weeks

    Unvalidated but standardized questionnaire on typical statin-related side effects

  2. Change from baseline Blood Pressure, diastolic at 8 weeks

    Time frame: Baseline, 8 weeks

    average of 3 measurements during 15 minutes

  3. Change from baseline Blood Pressure, systolic at 4 weeks

    Time frame: Baseline, 4 weeks

    average of 3 measurements during 15 minutes

  4. Change from baseline LDL cholesterol level at 8 weeks

    Time frame: Baseline, 8 weeks

    Calculated from Total Cholesterol, HDL Cholesterol and Triglycerides

  5. Change from baseline HDL cholesterol level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement in Serum

  6. Change from baseline non-HDL cholesterol level at 8 weeks

    Time frame: Baseline, 8 weeks

    Calculated from HDL and total cholesterol

  7. Change from baseline total cholesterol level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement in Serum

  8. Change from baseline triglycerides level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement in Serum

  9. Change from baseline Apo A1 level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement in Serum

  10. Change from baseline Apo B level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement in Serum

  11. Change from baseline lipoprotein A (LP(a)) level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement in Serum

  12. Change from baseline OxLDL level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement with ELISA

  13. Change from baseline gluathion (GSH) level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement with in house HPLC method

  14. Change from baseline malondialdehyde (MDA) level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement with ELISA

  15. Change from baseline Remnant Cholesterol at 8 weeks

    Time frame: Baseline, 8 weeks

    Calculated from total, HDL and LDL cholesterol

Other outcomes

  1. Change from baseline insuline level at 8 weeks

    Time frame: Baseline, 8 weeks

    Required to correctly interpret glucose levels, Measurement in Serum

  2. Change from baseline homocysteine level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement in Homocysteine Serum

  3. Change from baseline hs-CRP level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement in Serum

  4. Change from baseline creatinine level at 8 weeks

    Time frame: Baseline, 8 weeks

    Required to correctly interpret HbAc1 levels, Measurement in Serum

  5. Change from baseline HbA1c level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement in EDTA Whole Blood

  6. Change from baseline hemoglobine level at 8 weeks

    Time frame: Baseline, 8 weeks

    Required to correctly interpret HbAc1 levels, Measurement in EDTA Whole Blood

  7. Change from baseline creatine kinase (CK) level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement in serum

  8. Change from baseline C-peptide level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement in serum

  9. Change from baseline waist circumference at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement with measuring tape

  10. Change from baseline Body Mass Index (BMI) at 8 weeks

    Time frame: Baseline, 8 weeks

    weight and height will be combined to report BMI in kg/m^2

  11. Change from baseline glucose level at 8 weeks

    Time frame: Baseline, 8 weeks

    Measurement in Fluoride Plasma

Sponsors and collaborators

Lead sponsor

Nina Hermans

Other

Collaborators

  • University Hospital, Antwerp

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 6, 2021
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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