Olive Polyphenols in Cardiovascular Prevention

NCT04874961 | Completed Phase 4

• 1 other identifier: Olijfstudie 2021
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

• 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

Outcome Measures

Primary Outcomes (1)

• Change from baseline Blood Pressure, Systolic at 8 weeks

  average of 3 measurements during 15 minutes

  Baseline, 8 weeks

Secondary Outcomes (15)

• Frequency of side effects (+ their burden) as reported in the final questionnaire

  8 weeks

• Change from baseline Blood Pressure, diastolic at 8 weeks

  Baseline, 8 weeks

• Change from baseline Blood Pressure, systolic at 4 weeks

  Baseline, 4 weeks

• Change from baseline LDL cholesterol level at 8 weeks

  Baseline, 8 weeks

• Change from baseline HDL cholesterol level at 8 weeks

  Baseline, 8 weeks

Other Outcomes (11)

• Change from baseline insuline level at 8 weeks

  Baseline, 8 weeks

• Change from baseline homocysteine level at 8 weeks

  Baseline, 8 weeks

• Change from baseline hs-CRP level at 8 weeks

  Baseline, 8 weeks

Study Arms (2)

Standardized olive extract (Tensiofytol®)

EXPERIMENTAL

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

Dietary Supplement: Tensiofytol®

Placebo

PLACEBO COMPARATOR

3 capsules/day during dinner

Other: Placebo

Interventions

Tensiofytol® DIETARY_SUPPLEMENT

standardized olive extract

Standardized olive extract (Tensiofytol®)

Placebo OTHER

contains excipients only

Placebo

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systolic blood pressure ≥ 130 mmHg

You may not qualify if:

• \<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.

Sponsors & Collaborators

• Nina Hermans: lead
• University Hospital, Antwerp: collaborator

Study Sites (1)

UAntwerp, NatuRAPT

Wilrijk, Belgium

Location

MeSH Terms

Conditions

Isolated Systolic Hypertension

Condition Hierarchy (Ancestors)

Essential Hypertension; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Johan Bosmans, Prof. MD.

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 6, 2021
• Study Start: May 20, 2021
• Primary Completion: May 21, 2024
• Study Completion: May 21, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)