Olive Polyphenols in Cardiovascular Prevention.

Study Overview
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Brief Summary
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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 oleuropein 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.

Official Title
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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.

Conditions
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Metabolic Syndrome, High Blood Pressure, High Cholesterol, Dyslipidemias, High Blood Sugar

Intervention / Treatment
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* Dietary Supplement: Tensiofytol
* Dietary Supplement: Cholesfytol NG
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: LDL cholesterol level ≥ 130 mg/dL Blood pressure ≥ 130/85 mg Hg And at least 2 of the following 4 criteria: 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 supplements Use of cholesterol lowering medication and/or supplements 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standardized olive extract (Tensiofytol)<br>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 oleuropein and 20 mg hydroxytyrosol | Dietary Supplement: Tensiofytol<br>* standardized olive extract<br>|
| Experimental: Combination preparation (Cholesfytol NG)<br>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<br>* combination preparation<br>|
| Placebo Comparator: Placebo<br>3 capsules/day during dinner | Other: Placebo<br>* contains excipients only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Blood Pressure at 8 weeks | average of 3 measurements during 15 minutes | Baseline, 8 weeks | 
| Change from baseline Blood Pressure at 4 weeks | average of 3 measurements during 15 minutes | Baseline, 4 weeks | 
| Change from baseline LDL cholesterol level at 8 weeks | Calculated from Total Cholesterol, HDL Cholesterol and Triglycerides | Baseline, 8 weeks | 
| Change from baseline HDL cholesterol level at 8 weeks | Measurement in Serum | Baseline, 8 weeks | 
| Change from baseline total cholesterol level at 8 weeks | Measurement in Serum | Baseline, 8 weeks | 
| Change from baseline triglycerides level at 8 weeks | Measurement in Serum | Baseline, 8 weeks | 
| Change from baseline glucose level at 8 weeks | Measurement in Fluoride Plasma | Baseline, 8 weeks | 
| Change from baseline insuline level at 8 weeks | Required to correctly interpret glucose levels, Measurement in Serum | Baseline, 8 weeks | 
| Change from baseline Apo A1 level at 8 weeks | Measurement in Serum | Baseline, 8 weeks | 
| Change from baseline Apo B level at 8 weeks | Measurement in Serum | Baseline, 8 weeks | 
| Change from baseline homocysteine level at 8 weeks | Measurement in Homocysteine Serum | Baseline, 8 weeks | 
| Change from baseline lipoprotein A (LP(a)) level at 8 weeks | Measurement in Serum | Baseline, 8 weeks | 
| Change from baseline hs-CRP level at 8 weeks | Measurement in Serum | Baseline, 8 weeks | 
| Change from baseline creatinine level at 8 weeks | Required to correctly interpret HbAc1 levels, Measurement in Serum | Baseline, 8 weeks | 
| Change from baseline HbA1c level at 8 weeks | Measurement in EDTA Whole Blood | Baseline, 8 weeks | 
| Change from baseline hemoglobine level at 8 weeks | Required to correctly interpret HbAc1 levels, Measurement in EDTA Whole Blood | Baseline, 8 weeks | 
| Change from baseline OxLDL level at 8 weeks | Measurement with ELISA | Baseline, 8 weeks | 
| Change from baseline gluathion (GSH) level at 8 weeks | Measurement with in house HPLC method | Baseline, 8 weeks | 
| Change from baseline malondialdehyde (MDA) level at 8 weeks | Measurement with ELISA | Baseline, 8 weeks | 

Secondary Outcome Measures

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