NCT04874961CompletedPhase 4
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.
Source: ClinicalTrials.gov · Last updated 15 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 56 (actual)
- First submitted
- 27 Apr 2021
- Start date
- 20 May 2021
- Primary completion date
- 21 May 2024
- Lead sponsor
- Nina Hermans
- Diseases
- High blood pressure
- NCT number
- NCT04874961
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 56
- From 20 May 2021 to the primary completion date, 21 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of nutritional supplements or (chronic) medication\*
- 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.
Other illness
- Chronic illness (e.g. diabetes, atherosclerosis, reumatoid arthritis)
- Acute infection
Lab values
- Triglycerides \> 400 mg/dL
Other
- \<18 jaar
- \>76 jaar
- Smoking
- \> 14 alcoholic consumptions/week
- Current pregnancy or pregnancy wish during the study period
Who the study is looking for
- Systolic blood pressure ≥ 130 mmHg
Age in the registry: 18 years to 76 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UAntwerp, NatuRAPT Coordinator of this site? Confirm its status | Wilrijk | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.