EVOO and Metabolic Liver Health in MASLD

ConditionsMASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease Overweight

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorAzienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Arm AExperimental treatment 1 intervention

Group B: Arm BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame