Olive Polyphenols in Cardiovascular Prevention

NCT ID: NCT04874961

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-20
• Study Completion Date: 2024-05-21

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.

Conditions

Hypertension, Systolic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Standardized olive extract (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

Group Type: EXPERIMENTAL

Tensiofytol®

Intervention Type: DIETARY_SUPPLEMENT

standardized olive extract

Placebo

3 capsules/day during dinner

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

contains excipients only

Interventions

Tensiofytol®

standardized olive extract

Intervention Type: DIETARY_SUPPLEMENT

Placebo

contains excipients only

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 76 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: collaborator

Nina Hermans

OTHER

Sponsor Role: lead

Responsible Party

Nina Hermans

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Johan Bosmans, Prof. MD.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

UAntwerp, NatuRAPT

Wilrijk, , Belgium

Countries

Belgium

Other Identifiers

Olijfstudie 2021

Identifier Type: -

Identifier Source: org_study_id