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

NCT05282316 | Completed

• 1 other identifier: ASMS01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome

Keywords

Extra Virgin Olive Oil (EVOO); Metabolic syndrome; Mediterranean diet; Polyphenols; Cardiovascular risk; Liver steatosis; Inflammation

Outcome Measures

Primary Outcomes (6)

• Change of glycemic control induced by polyphenols enriched EVOO-MD.

  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.

  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.

  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

  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.

  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.

  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 Outcomes (6)

• Change in liver steatosis ultrasound pattern induced by polyphenols enriched EVOO-MD.

  From baseline to end of intervention (6 months)

• Change in visceral fat thickness induced by polyphenols enriched EVOO-MD.

  From baseline to end of intervention (6 months)

• Change in carotid intima-media thickness (cIMT) induced by polyphenols enriched EVOO-MD.

  From baseline to end of intervention (6 months)

• Change in endothelial disfunction induced by polyphenols enriched EVOO-MD.

  From baseline to end of intervention (6 months)

• EVOO effects on PBMC stress response gene expression

  From baseline to end of intervention (6 months)

Study Arms (2)

EVOO polyphenols enriched

ACTIVE COMPARATOR

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

EVOO standard

PLACEBO COMPARATOR

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

Interventions

EVOO polyphenols enriched DIETARY_SUPPLEMENT

Addition of 40 ml daily of healthy polyphenols enriched EVOO to mediterranean diet for 6 months

EVOO polyphenols enriched

EVOO standard DIETARY_SUPPLEMENT

Addition of 40 ml daily of standard EVOO to mediterranean diet for 6 months

EVOO standard

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

Department of Internal Medicine, University Hospital of Palermo

Palermo, Palermo, 90127, Italy

Location

Related Publications (14)

• Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Costa F; American Heart Association; National Heart, Lung, and Blood Institute. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation. 2005 Oct 25;112(17):2735-52. doi: 10.1161/CIRCULATIONAHA.105.169404. Epub 2005 Sep 12. No abstract available.

  PMID: 16157765 BACKGROUND

• Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5.

  PMID: 19805654 BACKGROUND

• Pastor R, Bouzas C, Tur JA. Beneficial effects of dietary supplementation with olive oil, oleic acid, or hydroxytyrosol in metabolic syndrome: Systematic review and meta-analysis. Free Radic Biol Med. 2021 Aug 20;172:372-385. doi: 10.1016/j.freeradbiomed.2021.06.017. Epub 2021 Jun 18.

  PMID: 34153478 BACKGROUND

• Schwingshackl L, Christoph M, Hoffmann G. Effects of Olive Oil on Markers of Inflammation and Endothelial Function-A Systematic Review and Meta-Analysis. Nutrients. 2015 Sep 11;7(9):7651-75. doi: 10.3390/nu7095356.

  PMID: 26378571 BACKGROUND

• George ES, Marshall S, Mayr HL, Trakman GL, Tatucu-Babet OA, Lassemillante AM, Bramley A, Reddy AJ, Forsyth A, Tierney AC, Thomas CJ, Itsiopoulos C, Marx W. The effect of high-polyphenol extra virgin olive oil on cardiovascular risk factors: A systematic review and meta-analysis. Crit Rev Food Sci Nutr. 2019;59(17):2772-2795. doi: 10.1080/10408398.2018.1470491. Epub 2018 Nov 13.

  PMID: 29708409 BACKGROUND

• Jimenez-Torres J, Alcala-Diaz JF, Torres-Pena JD, Gutierrez-Mariscal FM, Leon-Acuna A, Gomez-Luna P, Fernandez-Gandara C, Quintana-Navarro GM, Fernandez-Garcia JC, Perez-Martinez P, Ordovas JM, Delgado-Lista J, Yubero-Serrano EM, Lopez-Miranda J. Mediterranean Diet Reduces Atherosclerosis Progression in Coronary Heart Disease: An Analysis of the CORDIOPREV Randomized Controlled Trial. Stroke. 2021 Nov;52(11):3440-3449. doi: 10.1161/STROKEAHA.120.033214. Epub 2021 Aug 10. Erratum In: Stroke. 2021 Nov;52(11):e754. doi: 10.1161/STR.0000000000000393.

  PMID: 34372670 BACKGROUND

• Patti AM, Carruba G, Cicero AFG, Banach M, Nikolic D, Giglio RV, Terranova A, Soresi M, Giannitrapani L, Montalto G, Stoian AP, Banerjee Y, Rizvi AA, Toth PP, Rizzo M. Daily Use of Extra Virgin Olive Oil with High Oleocanthal Concentration Reduced Body Weight, Waist Circumference, Alanine Transaminase, Inflammatory Cytokines and Hepatic Steatosis in Subjects with the Metabolic Syndrome: A 2-Month Intervention Study. Metabolites. 2020 Oct 2;10(10):392. doi: 10.3390/metabo10100392.

  PMID: 33023123 BACKGROUND

• Gaforio JJ, Visioli F, Alarcon-de-la-Lastra C, Castaner O, Delgado-Rodriguez M, Fito M, Hernandez AF, Huertas JR, Martinez-Gonzalez MA, Menendez JA, Osada J, Papadaki A, Parron T, Pereira JE, Rosillo MA, Sanchez-Quesada C, Schwingshackl L, Toledo E, Tsatsakis AM. Virgin Olive Oil and Health: Summary of the III International Conference on Virgin Olive Oil and Health Consensus Report, JAEN (Spain) 2018. Nutrients. 2019 Sep 1;11(9):2039. doi: 10.3390/nu11092039.

  PMID: 31480506 BACKGROUND

• Sayon-Orea C, Razquin C, Bullo M, Corella D, Fito M, Romaguera D, Vioque J, Alonso-Gomez AM, Warnberg J, Martinez JA, Serra-Majem L, Estruch R, Tinahones FJ, Lapetra J, Pinto X, Tur JA, Lopez-Miranda J, Bueno-Cavanillas A, Delgado-Rodriguez M, Matia-Martin P, Daimiel L, Sanchez VM, Vidal J, Vazquez C, Ros E, Ruiz-Canela M, Sorli JV, Castaner O, Fiol M, Navarrete-Munoz EM, Aros F, Gomez-Gracia E, Zulet MA, Sanchez-Villegas A, Casas R, Bernal-Lopez R, Santos-Lozano JM, Corbella E, Bouzas C, Garcia-Arellano A, Basora J, Asensio EM, Schroder H, Monino M, Garcia de la Hera M, Tojal-Sierra L, Toledo E, Diaz-Lopez A, Goday A, Salas-Salvado J, Martinez-Gonzalez MA. Effect of a Nutritional and Behavioral Intervention on Energy-Reduced Mediterranean Diet Adherence Among Patients With Metabolic Syndrome: Interim Analysis of the PREDIMED-Plus Randomized Clinical Trial. JAMA. 2019 Oct 15;322(15):1486-1499. doi: 10.1001/jama.2019.14630.

  PMID: 31613346 BACKGROUND

• Riboli E, Kaaks R. The EPIC Project: rationale and study design. European Prospective Investigation into Cancer and Nutrition. Int J Epidemiol. 1997;26 Suppl 1:S6-14. doi: 10.1093/ije/26.suppl_1.s6.

  PMID: 9126529 BACKGROUND

• Jurado-Ruiz E, Varela LM, Luque A, Berna G, Cahuana G, Martinez-Force E, Gallego-Duran R, Soria B, de Roos B, Romero Gomez M, Martin F. An extra virgin olive oil rich diet intervention ameliorates the nonalcoholic steatohepatitis induced by a high-fat "Western-type" diet in mice. Mol Nutr Food Res. 2017 Mar;61(3). doi: 10.1002/mnfr.201600549. Epub 2016 Dec 13.

  PMID: 27749006 BACKGROUND

• Saibandith B, Spencer JPE, Rowland IR, Commane DM. Olive Polyphenols and the Metabolic Syndrome. Molecules. 2017 Jun 29;22(7):1082. doi: 10.3390/molecules22071082.

  PMID: 28661446 BACKGROUND

• Mirabelli M, Chiefari E, Arcidiacono B, Corigliano DM, Brunetti FS, Maggisano V, Russo D, Foti DP, Brunetti A. Mediterranean Diet Nutrients to Turn the Tide against Insulin Resistance and Related Diseases. Nutrients. 2020 Apr 12;12(4):1066. doi: 10.3390/nu12041066.

  PMID: 32290535 BACKGROUND

• Yubero-Serrano EM, Lopez-Moreno J, Gomez-Delgado F, Lopez-Miranda J. Extra virgin olive oil: More than a healthy fat. Eur J Clin Nutr. 2019 Jul;72(Suppl 1):8-17. doi: 10.1038/s41430-018-0304-x.

  PMID: 30487558 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome; Fatty Liver; Inflammation

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maurizio Soresi, MD

  maurizio.soresi@unipa.it

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Same organoleptic features of the two different kind of EVOO (polyphenols enriched and standard).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Model Details: Double-blind placebo-controlled

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 16, 2022
• Study Start: March 9, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 3, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)