RecruitingNot ApplicableNCT07412444

EVOO and Metabolic Liver Health in MASLD

Evaluation of the Effects of Extra Virgin Olive Oil Consumption on Hepatic Steatosis Parameters and on Glucose and Lipid Metabolism in Subjects With MASLD.


Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Enrollment

60 participants

Start Date

May 6, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

  • 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).
  • Pregnancy or breastfeeding.
  • Severe medical conditions that may compromise participation in the trial.
  • Individuals following a special diet.

Exclusion Criteria1

  • Subjects with BMI < 20 and BMI > 30.

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Interventions

DIETARY_SUPPLEMENTOil Supplementation - 3 tablespoons of oil

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

DIETARY_SUPPLEMENT9 Tablespoons of Oil

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


Locations(1)

UOS Data Science

Castellana Grotte, Italy, Italy

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NCT07412444


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