EVOO and Metabolic Liver Health in MASLD

NCT07412444 | Recruiting

• 1 other identifier: EvoLiveR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

MASLD is currently one of the most common chronic non-communicable diseases and the leading cause of liver-related mortality and morbidity, with a rising prevalence worldwide, especially in the presence of obesity, diabetes, and other cardio-metabolic risk factors. Lifestyle modification, particularly through the Mediterranean Diet, is the first-line intervention, and extra virgin olive oil is a key component thanks to its monounsaturated fatty acids and bioactive compounds with anti-inflammatory and antioxidant effects. Several studies indicate that extra virgin olive oil supplementation, especially within a Mediterranean Diet pattern, reduces hepatic steatosis, improves inflammation, oxidative stress, and glucose and lipid profiles, and may promote weight loss and reduction of fat mass, also through potential effects on the gut microbiota. EFSA recognizes protective effects with a daily intake of at least 20 g of extra virgin olive oil, but it is still unclear whether this amount is optimal for individuals with MASLD, particularly those who are overweight or obese

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease; Overweight

Keywords

MASLD; Overweight; EVOO; Glucose Metabolism; Lipid Metabolism

Outcome Measures

Primary Outcomes (3)

• The effect of intervention on CAP value (Controlled Attenuation Parameter)

  To evaluate the effects of a diet enriched with extra virgin olive oil (EVOO) on specific aspects associated with MASLD in steatotic subjects with 20 ≤ BMI \< 30, such as the degree of hepatic steatosis and fibrosis assessed by CAP value (Controlled Attenuation Parameter)

  at Baseline and after two months

• Change in circulating inflammatory cytokines

  Serum levels of inflammatory markers (high-sensitivity C-reactive protein, IL-6, IL-8, TNF-α, IL-4) measured in fasting blood samples.

  at Baseline and after two months

• Change in circulating liver enzymes

  Serum levels of liver enzymes (ALT, AST, γGT) measured in fasting blood samples

  at Baseline and after two months

Secondary Outcomes (3)

• Change in red blood cell membrane lipidomic profile

  at Baseline and after two months

• Change in gut microbiota taxonomic profile

  at Baseline and after two months

• Change in gut microbiota functional profile

  at Baseline and after two months

Study Arms (2)

Arm A

EXPERIMENTAL

Daily intake of 3 tablespoons (30 g, 270 kcal) of raw EVO oil included in the diet

Dietary Supplement: Oil Supplementation - 3 tablespoons of oil

Arm B

EXPERIMENTAL

Daily intake of 9 tablespoons (90 g, 810 kcal) of raw EVO oil included in the diet

Dietary Supplement: 9 Tablespoons of Oil

Interventions

9 Tablespoons of Oil DIETARY_SUPPLEMENT

Daily intake of 9 tablespoons (90 g, 810 kcal) of raw EVO oil included in the diet

Arm B

Oil Supplementation - 3 tablespoons of oil DIETARY_SUPPLEMENT

Daily intake of 3 tablespoons (30 g, 270 kcal) of raw EVO oil included in the diet

Arm A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with 20 ≤ BMI \< 30;
• Age range between 18 and 65 years, both sexes;
• Diagnosis of hepatic steatosis, made on the basis of recognized criteria (FibroScan \[CAP (controlled attenuation parameter) \> 288 dB/m\], FLI).

You may not qualify if:

• Subjects with BMI \< 20 and BMI \> 30.
• Pregnancy or breastfeeding.
• Severe medical conditions that may compromise participation in the trial.
• Individuals following a special diet.

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead

Study Sites (1)

UOS Data Science

Castellana Grotte, Italy, 70013, Italy

RECRUITING

Related Publications (5)

• Eslam M, Newsome PN, Sarin SK, Anstee QM, Targher G, Romero-Gomez M, Zelber-Sagi S, Wai-Sun Wong V, Dufour JF, Schattenberg JM, Kawaguchi T, Arrese M, Valenti L, Shiha G, Tiribelli C, Yki-Jarvinen H, Fan JG, Gronbaek H, Yilmaz Y, Cortez-Pinto H, Oliveira CP, Bedossa P, Adams LA, Zheng MH, Fouad Y, Chan WK, Mendez-Sanchez N, Ahn SH, Castera L, Bugianesi E, Ratziu V, George J. A new definition for metabolic dysfunction-associated fatty liver disease: An international expert consensus statement. J Hepatol. 2020 Jul;73(1):202-209. doi: 10.1016/j.jhep.2020.03.039. Epub 2020 Apr 8.

  PMID: 32278004 BACKGROUND

• Kim Y, Rydqvist P, Ramezani T, Haas JS, Bantel H, Buggisch P, Geier A, Hofmann WP, Mauss S, Roeb E, Schattenberg JM, Simon KG, Stefan N, Deterding K, Wiegand J, Pathil A, Tacke F. Metabolic Dysfunction-Associated Steatohepatitis Diagnosis and Management in Germany: Insights From an Expert Consensus Panel. Liver Int. 2025 Aug;45(8):e70225. doi: 10.1111/liv.70225.

  PMID: 40668568 BACKGROUND

• Zeng XF, Varady KA, Wang XD, Targher G, Byrne CD, Tayyem R, Latella G, Bergheim I, Valenzuela R, George J, Newberry C, Zheng JS, George ES, Spearman CW, Kontogianni MD, Ristic-Medic D, Peres WAF, Depboylu GY, Yang W, Chen X, Rosqvist F, Mantzoros CS, Valenti L, Yki-Jarvinen H, Mosca A, Sookoian S, Misra A, Yilmaz Y, Kim W, Fouad Y, Sebastiani G, Wong VW, Aberg F, Wong YJ, Zhang P, Bermudez-Silva FJ, Ni Y, Lupsor-Platon M, Chan WK, Mendez-Sanchez N, de Knegt RJ, Alam S, Treeprasertsuk S, Wang L, Du M, Zhang T, Yu ML, Zhang H, Qi X, Liu X, Pinyopornpanish K, Fan YC, Niu K, Jimenez-Chillaron JC, Zheng MH. The role of dietary modification in the prevention and management of metabolic dysfunction-associated fatty liver disease: An international multidisciplinary expert consensus. Metabolism. 2024 Dec;161:156028. doi: 10.1016/j.metabol.2024.156028. Epub 2024 Sep 11.

  PMID: 39270816 BACKGROUND

• Lockyer S, Rowland I, Spencer JPE, Yaqoob P, Stonehouse W. Impact of phenolic-rich olive leaf extract on blood pressure, plasma lipids and inflammatory markers: a randomised controlled trial. Eur J Nutr. 2017 Jun;56(4):1421-1432. doi: 10.1007/s00394-016-1188-y. Epub 2016 Mar 7.

  PMID: 26951205 BACKGROUND

• Marin-Alejandre BA, Cantero I, Perez-Diaz-Del-Campo N, Monreal JI, Elorz M, Herrero JI, Benito-Boillos A, Quiroga J, Martinez-Echeverria A, Uriz-Otano JI, Huarte-Muniesa MP, Tur JA, Martinez JA, Abete I, Zulet MA. Effects of two personalized dietary strategies during a 2-year intervention in subjects with nonalcoholic fatty liver disease: A randomized trial. Liver Int. 2021 Jul;41(7):1532-1544. doi: 10.1111/liv.14818. Epub 2021 Mar 1.

  PMID: 33550706 BACKGROUND

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rossella Tatoli, Dietician

CONTACT

+390804994652; rossella.tatoli@irccsdebellis.it

Rossella Donghia, Biologist

CONTACT

+390804994652; rossella.donghia@irccsdebellis.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dietician

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: February 17, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): May 6, 2027
• Study Completion (Estimated): May 6, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)