Olive Polyphenols in Cardiovascular Prevention.

Sponsor

Nina Hermans (Other)

Overall Status

Recruiting

CT.gov ID

NCT04874961

Collaborator

University Hospital, Antwerp (Other)

Enrollment

Location

Arms

6.4

Anticipated Duration (Months)

11.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate whether the use of a commercially available standardized olive extract (Tensiofytol) and a commercially available combination preparation (Cholesfytol NG) by individuals with metabolic syndrome

Leads to a clinically relevant reduction of blood pressure on the short term,
Leads to a clinically relevant reduction of cholesterol levels, especially LDL,
Leads to a change in oxidative stress biomarkers.

Participants will be stratified by sex and menopausal status before randomization to one of the three treatments for 8 weeks:

Tensiofytol: 100 mg oleuropeïne and 20 mg hydroxytyrosol per day
Cholesfytol NG: 2.9 mg monacoline K and 10 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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome High Blood Pressure High Cholesterol Dyslipidemias High Blood Sugar	Dietary Supplement: Tensiofytol Dietary Supplement: Cholesfytol NG Other: Placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Olive Polyphenols in Cardiovascular Prevention: Efficacy and Tolerability of a Commercially Available Standardized Olive Extract (Tensiofytol) as Compared to a Combination Preparation (Cholesfytol NG) and Placebo in Metabolic Syndrome: a RDBPC Trial.

Actual Study Start Date :

May 20, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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), equivalent to 100 mg oleuropeïne and 20 mg hydroxytyrosol	Dietary Supplement: Tensiofytol standardized olive extract
Experimental: Combination preparation (Cholesfytol NG) 3 capsules/day during dinner Per day: 67.2 mg red yeast rice powder (Monascus purpureus; equivalent to 2.9 mg monacoline K) 1000 mg amla dry extract (Phyllanthus emblica) 100 mg walnut leave dry extract (Juglans regia) 50 mg olive dry extract (Olea europaea; equivalent to 10 mg hydroxytyrosol)	Dietary Supplement: Cholesfytol NG combination preparation
Placebo Comparator: Placebo 3 capsules/day during dinner	Other: Placebo contains excipients only

Arm

Intervention/Treatment

Experimental: 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), equivalent to 100 mg oleuropeïne and 20 mg hydroxytyrosol

Dietary Supplement: Tensiofytol

standardized olive extract

Experimental: Combination preparation (Cholesfytol NG)

3 capsules/day during dinner Per day: 67.2 mg red yeast rice powder (Monascus purpureus; equivalent to 2.9 mg monacoline K) 1000 mg amla dry extract (Phyllanthus emblica) 100 mg walnut leave dry extract (Juglans regia) 50 mg olive dry extract (Olea europaea; equivalent to 10 mg hydroxytyrosol)

Dietary Supplement: Cholesfytol NG

combination preparation

Placebo Comparator: Placebo

3 capsules/day during dinner

Other: Placebo

contains excipients only

Outcome Measures

Primary Outcome Measures

Change from baseline Blood Pressure at 8 weeks [Baseline, 8 weeks]
average of 3 measurements during 15 minutes
Change from baseline Blood Pressure at 4 weeks [Baseline, 4 weeks]
average of 3 measurements during 15 minutes
Change from baseline LDL cholesterol level at 8 weeks [Baseline, 8 weeks]
Change from baseline HDL cholesterol level at 8 weeks [Baseline, 8 weeks]
Change from baseline total cholesterol level at 8 weeks [Baseline, 8 weeks]
Change from baseline triglycerides level at 8 weeks [Baseline, 8 weeks]
Change from baseline glucose level at 8 weeks [Baseline, 8 weeks]
Change from baseline insuline level at 8 weeks [Baseline, 8 weeks]
Required to correctly interpret glucose levels
Change from baseline Apo A1 level at 8 weeks [Baseline, 8 weeks]
Change from baseline Apo B level at 8 weeks [Baseline, 8 weeks]
Change from baseline homocysteine level at 8 weeks [Baseline, 8 weeks]
Change from baseline lipoprotein A (LP(a)) level at 8 weeks [Baseline, 8 weeks]
Change from baseline hs-CRP level at 8 weeks [Baseline, 8 weeks]
Change from baseline creatinine level at 8 weeks [Baseline, 8 weeks]
Required to correctly interpret HbAc1 levels
Change from baseline HbA1c level at 8 weeks [Baseline, 8 weeks]
Change from baseline hemoglobine level at 8 weeks [Baseline, 8 weeks]
Required to correctly interpret HbAc1 levels
Change from baseline OxLDL level at 8 weeks [Baseline, 8 weeks]
Change from baseline gluathion (GSH) level at 8 weeks [Baseline, 8 weeks]
Change from baseline malondialdehyde (MDA) level at 8 weeks [Baseline, 8 weeks]

Secondary Outcome Measures

Change from baseline creatine kinase (CK) level at 8 weeks [Baseline, 8 weeks]
Change from baseline Body Mass Index (BMI) at 8 weeks [Baseline, 8 weeks]
weight and height will be combined to report BMI in kg/m^2
Change from baseline waist circumference at 8 weeks [Baseline, 8 weeks]
Frequency of side effects (+ their burden) as reported in the final questionnaire [8 weeks]
Unvalidated but standardized questionnaire on typical statin-related side effects

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

LDL cholesterol level ≥ 160 mg/dL (corrected for LP(a))
Metabolic syndrome as defined by ATPIII-criteria: at least 3 of the following 5 criteria, but certainly high blood pressure:

Blood pressure ≥ 130/85 mg Hg or blood pressure medication (arterial hypertension)
Waist circumference > 102 cm for men or > 88 cm for women
Triglycerides ≥ 150mg/dL
HDL cholesterol < 40mg/dL for men or < 50mg/dL for women
Fasting glucose ≥ 110 mg/dL

Exclusion Criteria:

<18 jaar
70 jaar
Smoking
Use of nutritional supplemenrs
Use of cholesterol lowering medication or other medication except for blood pressure medication
Triglycerides > 400 mg/dL
2 alcoholic consumptions/day
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. Subjects who used cholesterol lowering medication or nutritional supplements with red yeast rice, can participate after a 6-week wash out.