Impact of Extra Virgin Olive Oil (EVOO) with Health Properties in Metabolic Syndrome

Plain-language summary

This study examines the health effect of polyphenol-enriched extra virgin olive oil (EVOO), compared with standard extra virgin olive oil, in people with metabolic syndrome. It enrolled people diagnosed with metabolic syndrome according to the NCEP ATP III criteria. It was a study with no assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

University of Palermo

Intervention

EVOO polyphenols enriched, EVOO standard

Start date

3/9/2022

Estimated completion

12/3/2024

Countries

Italy

Related genes

Locations

• Palermo, Italy

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.