Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID07412444

Evaluation of the Effects of Extra Virgin Olive Oil Consumption on Liver Fat and Metabolism in Adults with MASLD

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

60

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Metabolic dysfunction-associated steatotic liver disease (MASLD) is a common chronic condition linked to metabolic problems like obesity and diabetes, and it is a leading cause of liver-related illness and death. This research evaluates how consuming extra virgin olive oil (EVOO), a key part of the Mediterranean diet known for its anti-inflammatory and antioxidant properties, affects liver fat, inflammation, and metabolism in adults with MASLD who are overweight or have obesity. The study aims to clarify the optimal amount of EVOO intake for these individuals. Participants will follow a Mediterranean-style diet tailored to their age, sex, and lifestyle, with two different daily amounts of raw EVOO added: either 3 tablespoons (about 30 g) or 9 tablespoons (about 90 g). The study lasts about 74 days, beginning with a 14-day period where all participants consume 3 tablespoons of EVOO to reduce selection bias before being randomly assigned to one of the two dosage groups. EVOO is included as part of their total calorie intake and used raw throughout the day. During the study, participants will attend several visits for assessments including Fibroscan scans to measure liver fat, body measurements, blood tests to check liver enzymes and inflammation markers, and stool and urine samples to study gut microbiota and metabolism. Body weight will be tracked weekly to avoid significant changes that could affect results. The main outcomes measured are changes in liver fat levels, inflammatory cytokines, and liver enzymes after two months of treatment. Secondary outcomes include changes in blood lipid profiles and gut microbiota composition.

CONDITIONS

Brief 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...

  • Adults aged between 18 and 65 years
  • Body mass index (BMI) between 20 and less than 30
  • Diagnosis of hepatic steatosis based on FibroScan (CAP > 288 dB/m) or recognized criteria
  • Both males and females are eligible
Not Eligible

You will not qualify if you...

  • Body mass index (BMI) less than 20 or greater than 30
  • Presence of conditions causing liver fat other than those included
  • Pregnancy or breastfeeding
  • Severe medical conditions that prevent participation
  • Following a special diet

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Run-in Period

Duration - 14 days

Participants consume a predefined amount of extra virgin olive oil (3 tablespoons per day) for 14 days to reduce selection bias before randomization.

1 visit (in-person) after 14 days for reassessment

Treatment

Duration - Approximately 74 days

Participants are randomized to consume an isocaloric Mediterranean-style diet with either 3 tablespoons or 9 tablespoons of extra virgin olive oil daily, used raw at any time of day.

3 visits (in-person) during treatment at day 0 (enrollment), day 30, and day 60

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

R

Rossella Donghia, Biologist

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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Published Research Related To This Trial

A new definition for metabolic dysfunction-associated fatty liver disease: An international expert consensus statement.

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https://pubmed.ncbi.nlm.nih.gov/32278004

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Yestle Kim, Peter Rydqvist, Thomas Ramezani...

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The role of dietary modification in the prevention and management of metabolic dysfunction-associated fatty liver disease: An international multidisciplinary expert consensus.

Xu-Fen Zeng, Krista A Varady, Xiang-Dong Wang...

https://pubmed.ncbi.nlm.nih.gov/39270816

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Effects of two personalized dietary strategies during a 2-year intervention in subjects with nonalcoholic fatty liver disease: A randomized trial.

Bertha A Marin-Alejandre, Irene Cantero, Nuria Perez-Diaz-Del-Campo...

https://pubmed.ncbi.nlm.nih.gov/33550706