CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 56 enrolled
Drug / intervention
Tensiofytol® +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04874961
NCT04874961Phase 4Completed

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.

Nina Hermans·interventional·Posted May 6, 2021·Updated Nov 15, 2024

In Brief

A Phase 4 clinical trial evaluating Tensiofytol® and Placebo for Hypertension, Systolic. Completed, enrolled 56 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedMay 6, 2021
Enrollment StartMay 20, 2021
Primary CompletionMay 21, 2024
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 5.2 years ago

Interventions

Tensiofytol®dietary

standardized olive extract

Placeboother

contains excipients only