Olive Polyphenols in Cardiovascular Prevention

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension, Systolic
• Intervention / Treatment: Other: Placebo; Dietary supplement: Tensiofytol®

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Nina Hermans, Prof.; Phone Number: 003232652732; Email: nina.hermans@uantwerpen.be
• Study Contact Backup: Name: Stef Lauwers; Phone Number: 003232655134; Email: stef.lauwers@uantwerpen.be

Study Locations

• Belgium
  • Wilrijk, Belgium
    • Recruiting
    • UAntwerp, NatuRAPT
    • Contact: Nina Hermans, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 3 capsules/day during dinner	Other: Placebo; contains excipients only
Experimental: Standardized olive extract (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	Dietary supplement: Tensiofytol®; standardized olive extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Blood Pressure, Systolic at 8 weeks	average of 3 measurements during 15 minutes	Baseline, 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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
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	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 non-HDL cholesterol level at 8 weeks	Calculated from HDL and total cholesterol	Baseline, 8 weeks
Change from baseline Remnant Cholesterol at 8 weeks	Calculated from total, HDL and LDL cholesterol	Baseline, 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline glucose level at 8 weeks	Measurement in Fluoride Plasma	Baseline, 8 weeks
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	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 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 waist circumference at 8 weeks	Measurement with measuring tape	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

Collaborators and Investigators

• Sponsor: Nina Hermans
• Collaborators: University Hospital, Antwerp
• Investigators: Principal Investigator: Johan Bosmans, Prof. MD., University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 6, 2021

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Isolated Systolic Hypertension
• Other Study ID Numbers: Olijfstudie 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No