Clinical trial

EVOO and Metabolic Liver Health in MASLD

Recruiting now · Not applicable · 1 countries · Registry ID NCT07412444

Recruiting nowNot applicableInterventional

What this study 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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersAccepted

ConditionMASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Overweight

Full registry 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.

Treatments and study arms

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

Primary outcomes

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 cytokinesat 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 enzymesat Baseline and after two months

Serum levels of liver enzymes (ALT, AST, γGT) measured in fasting blood samples

Study locations

1 locations were listed when this page was built. The first 40 are shown.

UOS Data Science🇮🇹 Castellana Grotte, Italy, Italy

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