Olive Polyphenols in Cardiovascular Prevention.

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.

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.

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

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)

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.