NCT04874961

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Nina Hermans · Academic / Other
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension, Systolic

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Tensiofytol®	standardized olive extract
OTHER	Placebo	contains excipients only

Timeline

• Start date: 2021-05-20
• Primary completion: 2024-05-21
• Completion: 2024-05-21
• First posted: 2021-05-06
• Last updated: 2024-11-15

Locations

1 site across 1 country: Belgium