Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT07412444

EVOO and Metabolic Liver Health in MASLD

Led by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · Updated on 2026-05-06

60

Participants Needed

1

Research Sites

104 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

EVOO and Metabolic Liver Health in MASLD

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • BMI between 20 and less than 30
  • Age between 18 and 65 years, both sexes
  • Diagnosis of hepatic steatosis confirmed by FibroScan (CAP > 288 dB/m) or Fatty Liver Index (FLI)
Not Eligible

You will not qualify if you...

  • BMI less than 20 or greater than 30
  • Any condition causing liver fat other than those in inclusion criteria
  • Pregnancy or breastfeeding
  • Severe medical conditions that could affect participation
  • Following a special diet

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UOS Data Science

Castellana Grotte, Italy, Italy, 70013

Actively Recruiting

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Research Team

R

Rossella Tatoli, Dietician

CONTACT

R

Rossella Donghia, Biologist

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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