Extra virgin olive oil for liver and metabolic 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.
This trial will test whether taking extra virgin olive oil every day helps adults with MASLD and overweight reduce liver fat and improve blood sugar and cholesterol.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis Academic / other |
| Locations | 1 site (Castellana Grotte, Italy) |
| Trial ID | NCT07412444 on ClinicalTrials.gov |
What this trial studies
Adults aged 18–65 with BMI 20–30 and confirmed hepatic steatosis will be assigned to receive daily extra virgin olive oil supplementation at specified amounts and followed for changes in liver and metabolic outcomes. Steatosis is confirmed by FibroScan CAP (>288 dB/m) or FLI at baseline, and the trial tracks liver fat, blood glucose, lipid profiles, inflammatory markers, body weight and composition during the intervention. The protocol may include gut microbiota analyses to explore mechanisms linking oil intake to metabolic effects. The goal is to determine whether specific supplemental amounts of extra virgin olive oil added to participants' diets produce measurable improvements in liver and cardiometabolic health.
Who should consider this trial
Good fit: Adults 18–65 years old with BMI between 20 and 30 and confirmed hepatic steatosis (FibroScan CAP >288 dB/m or FLI) are the intended participants.
Not a fit: People with BMI below 20 or above 30, other causes of liver steatosis, pregnancy or breastfeeding, severe comorbidities, or those on special diets are unlikely to be eligible or to benefit from the intervention as tested.
Why it matters
Potential benefit: If successful, daily extra virgin olive oil could reduce liver fat and improve glucose, lipid, and inflammatory markers in people with MASLD.
How similar studies have performed: Previous trials and meta-analyses of extra virgin olive oil within Mediterranean diet patterns have reported reductions in liver fat and improvements in metabolic markers, but optimal dosing and direct causal evidence remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * Subjects with BMI \< 20 and BMI \> 30. * Presence of any condition that may influence the occurrence of steatosis other than the conditions representing inclusion criteria. * Pregnancy or breastfeeding. * Severe medical conditions that may compromise participation in the trial. * Individuals following a special diet.
Where this trial is running
Castellana Grotte, Italy
- UOS Data Science — Castellana Grotte, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Rossella Tatoli, Dietician
- Email: rossella.tatoli@irccsdebellis.it
- Phone: +390804994652
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.