Olive Polyphenols in Cardiovascular Prevention

Phase 4

Completed

• Conditions: Hypertension, Systolic
• Interventions: Other: Placebo; Dietary Supplement: Tensiofytol®

• Registration Number: NCT04874961
• Lead Sponsor: Nina Hermans

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-04-30
• Study First Posted: 2021-05-06
• Study Start: 2021-05-20
• Status Verified: 2024-01
• Primary Completion: 2024-05-21
• Study Completion: 2024-05-21
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	3 capsules/day during dinner
Standardized olive extract (Tensiofytol®)	Tensiofytol®	3 capsules/day during dinner Per day: 334 mg olive leave dry extract and 106 mg olive fruit dry extract (Olea europaea L.), equivalent to 100 mg oleuropein and 20 mg hydroxytyrosol

Primary Outcome Measures

Name	Time	Method
Change from baseline Blood Pressure, Systolic at 8 weeks	Baseline, 8 weeks	average of 3 measurements during 15 minutes

Secondary Outcome Measures

Name	Time	Method
Change from baseline Blood Pressure, systolic at 4 weeks	Baseline, 4 weeks	average of 3 measurements during 15 minutes
Change from baseline OxLDL level at 8 weeks	Baseline, 8 weeks	Measurement with ELISA
Change from baseline HDL cholesterol level at 8 weeks	Baseline, 8 weeks	Measurement in Serum
Change from baseline total cholesterol level at 8 weeks	Baseline, 8 weeks	Measurement in Serum
Change from baseline triglycerides level at 8 weeks	Baseline, 8 weeks	Measurement in Serum
Change from baseline gluathion (GSH) level at 8 weeks	Baseline, 8 weeks	Measurement with in house HPLC method
Frequency of side effects (+ their burden) as reported in the final questionnaire	8 weeks	Unvalidated but standardized questionnaire on typical statin-related side effects
Change from baseline LDL cholesterol level at 8 weeks	Baseline, 8 weeks	Calculated from Total Cholesterol, HDL Cholesterol and Triglycerides
Change from baseline Apo A1 level at 8 weeks	Baseline, 8 weeks	Measurement in Serum
Change from baseline Apo B level at 8 weeks	Baseline, 8 weeks	Measurement in Serum
Change from baseline malondialdehyde (MDA) level at 8 weeks	Baseline, 8 weeks	Measurement with ELISA
Change from baseline Blood Pressure, diastolic at 8 weeks	Baseline, 8 weeks	average of 3 measurements during 15 minutes
Change from baseline non-HDL cholesterol level at 8 weeks	Baseline, 8 weeks	Calculated from HDL and total cholesterol
Change from baseline lipoprotein A (LP(a)) level at 8 weeks	Baseline, 8 weeks	Measurement in Serum
Change from baseline Remnant Cholesterol at 8 weeks	Baseline, 8 weeks	Calculated from total, HDL and LDL cholesterol

Trial Locations

Locations (1)

UAntwerp, NatuRAPT; 🇧🇪 Wilrijk, Belgium