Olive Polyphenols in Cardiovascular Prevention.
Metabolic Syndrome, High Blood Pressure, High Cholesterol
About this trial
This is an interventional treatment trial for Metabolic Syndrome
Eligibility Criteria
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.
Sites / Locations
- UAntwerp, NatuRARecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Standardized olive extract (Tensiofytol)
Combination preparation (Cholesfytol NG)
Placebo
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)
3 capsules/day during dinner