Olive Polyphenols in Cardiovascular Prevention

Nina Hermans

Status and phase: Completed; Phase 4

Conditions: Hypertension, Systolic

Treatments: Dietary Supplement: Tensiofytol®; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04874961

Olijfstudie 2021

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 76 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

Standardized olive extract (Tensiofytol®)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Tensiofytol®

Placebo

Placebo Comparator group

Description:

3 capsules/day during dinner

Treatment:

Other: Placebo