EVOO and Metabolic Liver Health in MASLD

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Study 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

Primary outcome measure(s)

• The effect of intervention on CAP value (Controlled Attenuation Parameter) — at Baseline and after two months
  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)
• Change in circulating inflammatory cytokines — at Baseline and after two months
  Serum levels of inflammatory markers (high-sensitivity C-reactive protein, IL-6, IL-8, TNF-α, IL-4) measured in fasting blood samples.
• Change in circulating liver enzymes — at Baseline and after two months
  Serum levels of liver enzymes (ALT, AST, γGT) measured in fasting blood samples

Trial sites (1)

More Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis trials in Italy

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