Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT04874961
Brief 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:
NCT04874961
Study Brief:
Protocol Section:
NCT04874961