Olive Polyphenols in Cardiovascular Prevention

Hypertension, Systolic Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04874961
• Other study ID #: Olijfstudie 2021
• Status: Recruiting
• Phase: Phase 4
• Start date: May 20, 2021
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Universiteit Antwerpen
• Contact: Stef Lauwers
• Phone: 003232655134
• Email: stef.lauwers[@]uantwerpen.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 76 Years

Eligibility

Inclusion Criteria:

• Systolic blood pressure = 130 mmHg

Exclusion Criteria:

• <18 jaar

• >76 jaar

• Smoking

• Use of nutritional supplements or (chronic) medication*

• Triglycerides > 400 mg/dL

• > 14 alcoholic consumptions/week

• Chronic illness (e.g. diabetes, atherosclerosis, reumatoid arthritis)

• Acute infection

• Current pregnancy or pregnancy wish during the study period

• 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.

Related Conditions & MeSH terms

• Hypertension, Systolic
• Isolated Systolic Hypertension

Intervention

Dietary Supplement:
• Tensiofytol®
standardized olive extract

Other:
• Placebo
contains excipients only

Locations

Country	Name	City	State
Belgium	UAntwerp, NatuRAPT	Wilrijk

Sponsors (2)

Lead Sponsor	Collaborator
Nina Hermans	University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline insuline level at 8 weeks	Required to correctly interpret glucose levels, Measurement in Serum	Baseline, 8 weeks
Other	Change from baseline homocysteine level at 8 weeks	Measurement in Homocysteine Serum	Baseline, 8 weeks
Other	Change from baseline hs-CRP level at 8 weeks	Measurement in Serum	Baseline, 8 weeks
Other	Change from baseline creatinine level at 8 weeks	Required to correctly interpret HbAc1 levels, Measurement in Serum	Baseline, 8 weeks
Other	Change from baseline HbA1c level at 8 weeks	Measurement in EDTA Whole Blood	Baseline, 8 weeks
Other	Change from baseline hemoglobine level at 8 weeks	Required to correctly interpret HbAc1 levels, Measurement in EDTA Whole Blood	Baseline, 8 weeks
Other	Change from baseline creatine kinase (CK) level at 8 weeks	Measurement in serum	Baseline, 8 weeks
Other	Change from baseline C-peptide level at 8 weeks	Measurement in serum	Baseline, 8 weeks
Other	Change from baseline waist circumference at 8 weeks	Measurement with measuring tape	Baseline, 8 weeks
Other	Change from baseline Body Mass Index (BMI) at 8 weeks	weight and height will be combined to report BMI in kg/m^2	Baseline, 8 weeks
Other	Change from baseline glucose level at 8 weeks	Measurement in Fluoride Plasma	Baseline, 8 weeks
Primary	Change from baseline Blood Pressure, Systolic at 8 weeks	average of 3 measurements during 15 minutes	Baseline, 8 weeks
Secondary	Frequency of side effects (+ their burden) as reported in the final questionnaire	Unvalidated but standardized questionnaire on typical statin-related side effects	8 weeks
Secondary	Change from baseline Blood Pressure, diastolic at 8 weeks	average of 3 measurements during 15 minutes	Baseline, 8 weeks
Secondary	Change from baseline Blood Pressure, systolic at 4 weeks	average of 3 measurements during 15 minutes	Baseline, 4 weeks
Secondary	Change from baseline LDL cholesterol level at 8 weeks	Calculated from Total Cholesterol, HDL Cholesterol and Triglycerides	Baseline, 8 weeks
Secondary	Change from baseline HDL cholesterol level at 8 weeks	Measurement in Serum	Baseline, 8 weeks
Secondary	Change from baseline non-HDL cholesterol level at 8 weeks	Calculated from HDL and total cholesterol	Baseline, 8 weeks
Secondary	Change from baseline total cholesterol level at 8 weeks	Measurement in Serum	Baseline, 8 weeks
Secondary	Change from baseline triglycerides level at 8 weeks	Measurement in Serum	Baseline, 8 weeks
Secondary	Change from baseline Apo A1 level at 8 weeks	Measurement in Serum	Baseline, 8 weeks
Secondary	Change from baseline Apo B level at 8 weeks	Measurement in Serum	Baseline, 8 weeks
Secondary	Change from baseline lipoprotein A (LP(a)) level at 8 weeks	Measurement in Serum	Baseline, 8 weeks
Secondary	Change from baseline OxLDL level at 8 weeks	Measurement with ELISA	Baseline, 8 weeks
Secondary	Change from baseline gluathion (GSH) level at 8 weeks	Measurement with in house HPLC method	Baseline, 8 weeks
Secondary	Change from baseline malondialdehyde (MDA) level at 8 weeks	Measurement with ELISA	Baseline, 8 weeks
Secondary	Change from baseline Remnant Cholesterol at 8 weeks	Calculated from total, HDL and LDL cholesterol	Baseline, 8 weeks