Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-25 @ 12:42 PM
Study NCT ID:
NCT04874961
Status:
COMPLETED
Last Update Posted:
2024-11-15
First Post:
2021-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Olive Polyphenols in Cardiovascular Prevention
Sponsor:
Nina Hermans
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: