Impact of Extra Virgin Olive Oil (EVOO) With Health Properties in Metabolic Syndrome
Metabolic Syndrome
About this trial
This is an interventional prevention trial for Metabolic Syndrome focused on measuring Extra Virgin Olive Oil (EVOO), Metabolic syndrome, Mediterranean diet, Polyphenols, Cardiovascular risk, Liver steatosis, Inflammation
Eligibility Criteria
Inclusion Criteria:
- diagnosis of metabolic syndrome according the revised NCEP ATP III criteria; three or more of the following five criteria are met: waist circumference over 102 cm/40 inches (men) or 88 cm/35 inches (women), blood pressure over 130/85 mmHg, fasting triglyceride level over 150 mg/dl, fasting high-density lipoprotein cholesterol level less than 40 mg/dl (men) or 50 mg/dl (women) and fasting blood sugar over 100 mg/dl.
- Hepatitis B virus (HBV) and hepatitis C virus (HCV) negativity.
Exclusion Criteria:
- alcohol intake (>30 g/day for men and >20 g/day for women);
- acute or chronic hepatic and/or cardiac failure;
- acute or chronic kidney disease (stage G4 Kidney Disease: Improving Global Outcomes (KDIGO) revised classification, glomerular filtration rate <30 mL/min/1.73 m2);
- neoplasms;
- autoimmune or acute and chronic inflammatory diseases;
- acute or chronic infective diseases;
- pregnancy and/or breastfeeding.
Sites / Locations
- Department of Internal Medicine, University Hospital of PalermoRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
EVOO polyphenols enriched
EVOO standard
Fifteen subjects with metabolic syndrome will be randomly enrolled each year (3 years of study planned), to the addition of 40 ml daily of healthy polyphenols enriched EVOO to their mediterranean diet for the duration of six months
Fifteen subjects with metabolic syndrome will be randomly enrolled each year (3 years of study planned), to the addition of 40 ml daily of standard EVOO to their mediterranean diet for the duration of six months