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

December 3, 2024 updated by: Aurelio Seidita, University of Palermo

Impact of Extra Virgin Olive Oil (EVOO) with Health Properties in Improving the Overall Health Status and Preventing Cardiovascular Risk in Metabolic Syndrome

Metabolic syndrome (MS), defined according to the revised Adult Treatment Panel III - National Cholesterol Education Program (ATP III - NCEP) criteria, represents a widespread condition in Western populations (prevalence ranging from 22% to about 33%) and with a trend that increases with time and age. MS, not differently from each of the components that characterize it, is a known risk factor for cardiovascular and metabolic diseases. To date, national and international panels indicate lifestyle modification as the only indication for treating MS and reducing the risk of cardiovascular and metabolic diseases. The increase in daily physical activity and the modification of the diet are therefore the cornerstones of the treatment.

The Mediterranean Diet (MD) represents a traditional value of the Italian population which has shown in several studies a protective effect on mortality and survival free from cardiovascular events. The added value of MD is the presence of extra virgin olive oil (EVOO), a healthy food with high content of monounsaturated fatty acids, especially oleic acid, and variable concentrations (range 50-800 mg/kg) of phenols (oleuropein, ligstroside, and oleocanthal, and their derivatives phenolic alcohols, such as hydroxytyrosol and tyrosol). Olive oil is defined as healthy according to EC Reg. 432/2012. A good EVOO contains about 75% of oleic acid although a variability between 55% and 83% of all fatty acids is expected according to the World Health Organization. The polyphenols content plays a key role in the choice of the type and quantity of oil with health objectives, with particular reference to the unsaturated and polyunsaturated component (oleic acid, linoleic acid, alpha linolenic acid). Phenolic compounds not only determine EVOO main organoleptic qualities (oxidative stability and specific flavor and taste features) but, theoretically, make it a substance with antioxidant, antiinflammatory, insulin-sensitizing, cardioprotective, antiatherogenic, neuroprotective, immunomodulatory and anticancer activity.

The study aims to use a polyphenols enriched EVOO with health properties, derived from different cultivation variants of olives (cultivars), chosen on the basis of preliminary research, coming from Sicilian harvesting campaigns, to evaluate its potential to modify 'in vivo', in subjects with MS, some clinical and laboratory parameters inferring cardiovascular risk, metabolism and inflammation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Metabolic syndrome (MS), defined according to the to the revised Adult Treatment Panel III - National Cholesterol Education Program (ATP III - NCEP) criteria,, represents a widespread condition in Western populations (absolute prevalence ranging from 22% to about 33%) and with a trend that increases with time and age (it is expected that its prevalence will increase by about 53% by 2035). MS, not differently from each of the components that characterize it, is a known risk factor for cardiovascular diseases (relative risk (RR) 1.53-2.18) and type 2 diabetes mellitus (RR 3.53-5.17). To date, national and international panels indicate lifestyle modification as the only indication for treating MS and reducing the risk of cardiovascular and metabolic diseases. The increase in daily physical activity and the modification of the diet are therefore the cornerstones of the treatment.

The Mediterranean Diet (MD) represents a traditional value of the Italian population which has shown in several studies a protective effect on mortality and survival free from cardiovascular events. The added value of MD is the presence of extra virgin olive oil (EVOO), a healthy food with high content of monounsaturated fatty acids, especially oleic acid, and variable concentrations (range 50-800 mg/kg) of phenols (oleuropein, ligstroside, and oleocanthal, and their derivatives phenolic alcohols, such as hydroxytyrosol and tyrosol). Olive oil is defined as healthy according to European Commission (EC) Reg. 432/2012. A good EVOO contains about 75% of oleic acid although a variability between 55% and 83% of all fatty acids is expected according to the World Health Organization. The polyphenols content plays a key role in the choice of the type and quantity of oil with health objectives, with particular reference to the unsaturated and polyunsaturated component (oleic acid, linoleic acid, alpha linolenic acid). Phenolic compounds not only determine EVOO main organoleptic qualities (oxidative stability and specific flavor and taste features) but, theoretically, make it a substance with antioxidant, antiinflammatory, insulin-sensitizing, cardioprotective, antiatherogenic, neuroprotective, immunomodulatory and anticancer activity.

Any beneficial substance, including olive oil, goes through a series of biochemical processes before reaching the target organ, by the digestive enzymes and bacteria of the gut microbiota, or the eventual formation of active metabolites after the first liver passage; thus, an exclusively 'in vitro' evaluation of a substance on target cells does not always represent the physiological model of the interaction of these substances with the organism.

The study aims to use a polyphenols enriched EVOO with health properties, derived from different cultivation variants of olives (cultivars), chosen on the basis of preliminary research, coming from Sicilian harvesting campaigns, to evaluate its potential to modify 'in vivo', in subjects with MS, some clinical and laboratory parameters inferring cardiovascular risk, metabolism and inflammation.

Preliminarily, in the phase of the olive harvesting campaigns (three different harvesting periods carried out between November and December: green, mature and advanced ripening), the different indigenous cultivars coming from the same area of Western Sicily (precisely from Val di Mazara, Valle del Belice, Trapani valleys and called Biancolilla, Nocellara, Cerasuolo) will be subjected to biochemical analyses which will aim to identify those with the highest oleic acid and polyphenols content, which will contribute to the enhancement of the specific territory and to the maintenance of biodiversity.

The general objective of the study is to strengthen and enhance the research chain in the nutraceutical and health food sector and the cooperation between the research system and local companies, to support the maximum diffusion and use of new therapeutic substances and advanced technologies for treatment and prevention, and, at the same time, contributing to competitiveness and economic growth by raising the level of scientific-technical skills and knowledge in the production system and in Institutions.

The main objectives of the research, therefore, will be the following:

  1. Identification and selection of specific autochthonous cultivar able to provide a high quality and polyphenols enriched EVOO.
  2. Establish potential benefits of a polyphenols enriched EVOO-MD assessing the improvement over metabolic (lipidic and glycemic status), inflammatory (cytokines) and cardiovascular (cIMT and endothelial dysfunction) parameters.
  3. Establish potential benefits of a polyphenols enriched EVOO-MD assessing the improvement over liver steatosis.
  4. Analysis of polyphenols enriched EVOO effects on peripheral blood mononuclear cells (PBMC) gene expression exploring their potential use as diagnostic and therapeutic response tool.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Palermo, Italy, 90127
        • Department of Internal Medicine, University Hospital of Palermo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EVOO polyphenols enriched
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
Dietary supplement: EVOO polyphenols enriched
Addition of 40 ml daily of healthy polyphenols enriched EVOO to mediterranean diet for 6 months
Placebo Comparator: 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 standard EVOO to their mediterranean diet for the duration of six months
Dietary supplement: EVOO standard
Addition of 40 ml daily of standard EVOO to mediterranean diet for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of glycemic control induced by polyphenols enriched EVOO-MD.
Time Frame: From baseline to end of intervention (6 months)
Statistically significant change (p<0.05) from baseline (T0) to end of intervention (T1) of glycated hemoglobin levels.
From baseline to end of intervention (6 months)
Change of insulin resistance induced by polyphenols enriched EVOO-MD.
Time Frame: From baseline to end of intervention (6 months)
Statistically significant change (p<0.05) from baseline (T0) to end of intervention (T1) of (HOMA-IR) index.
From baseline to end of intervention (6 months)
Change of high density lipoproteins levels induced by polyphenols enriched EVOO-MD.
Time Frame: From baseline to end of intervention (6 months)
Statistically significant change (p<0.05) from baseline (T0) to end of intervention (T1) of high density lipoproteins (HDL) levels.
From baseline to end of intervention (6 months)
Change of triglycerides levels induced by polyphenols enriched
Time Frame: From baseline to end of intervention (6 months)
Statistically significant change (p<0.05) from baseline (T0) to end of intervention (T1) of triglycerides levels.
From baseline to end of intervention (6 months)
Change of inflammatory parameter tumor necrosis factor (TNF)-α induced by polyphenols enriched EVOO-MD.
Time Frame: From baseline to end of intervention (6 months)
Statistically significant change (p<0.05) from baseline (T0) to end of intervention (T1) of TNF-α levels.
From baseline to end of intervention (6 months)
Change of inflammatory parameter interleukine (IL)-6, induced by polyphenols enriched EVOO-MD.
Time Frame: From baseline to end of intervention (6 months)
Statistically significant change (p<0.05) from baseline (T0) to end of intervention (T1) of tumor necrosis factor IL-6 levels.
From baseline to end of intervention (6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in liver steatosis ultrasound pattern induced by polyphenols enriched EVOO-MD.
Time Frame: From baseline to end of intervention (6 months)
Statistically significant change from baseline (T0) to end of intervention (T1) of liver ultrasound steatosis pattern by ultrasonography.
From baseline to end of intervention (6 months)
Change in visceral fat thickness induced by polyphenols enriched EVOO-MD.
Time Frame: From baseline to end of intervention (6 months)
Statistically significant change (p<0.05) from baseline (T0) to end of intervention (T1) of visceral fat thickness by ultrasonography.
From baseline to end of intervention (6 months)
Change in carotid intima-media thickness (cIMT) induced by polyphenols enriched EVOO-MD.
Time Frame: From baseline to end of intervention (6 months)
Statistically significant change (p <0.05) from baseline (T0) to end of intervention (T1) of cIMT by ultrasonography.
From baseline to end of intervention (6 months)
Change in endothelial disfunction induced by polyphenols enriched EVOO-MD.
Time Frame: From baseline to end of intervention (6 months)
Statistically significant change (p <0.05) from baseline (T0) to end of intervention (T1) in endothelial dysfunction, by flow-mediated dilatation technique of the brachial artery.
From baseline to end of intervention (6 months)
EVOO effects on PBMC stress response gene expression
Time Frame: From baseline to end of intervention (6 months)
Statistically significant change (p <0.05) from baseline (T0) to end of intervention (T1) of expression of nuclear protein 1 (NUPR1)
From baseline to end of intervention (6 months)
EVOO effects on PBMC lipid metabolism gene expression
Time Frame: From baseline to end of intervention (6 months)
Statistically significant change (p <0.05) from baseline (T0) to end of intervention (T1) of expression of Acetyl-Coenzyme A Carboxylase 1 (ACC1).
From baseline to end of intervention (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Palermo

Investigators

  • Study Director: Maurizio Soresi, MD, maurizio.soresi@unipa.it

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2022

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

December 3, 2024

Study Registration Dates

First Submitted

February 18, 2022

First Submitted That Met QC Criteria

March 7, 2022

First Posted (Actual)

March 16, 2022

Study Record Updates

Last Update Posted (Actual)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASMS01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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