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临床试验/NCT07412444
NCT07412444招募中不适用

Evaluation of the Effects of Extra Virgin Olive Oil Consumption on Hepatic Steatosis Parameters and on Glucose and Lipid Metabolism in Subjects With MASLD.

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年5月6日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
The effect of intervention on CAP value (Controlled Attenuation Parameter)

研究概览

简要总结

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

详细描述

Metabolic dysfunction-associated steatotic liver disease (MASLD) is one of the most widespread non-communicable chronic diseases worldwide and the leading cause of liver-related mortality and morbidity. It currently affects about 38% of the global adult population and between 7% and 14% of the pediatric population, and projections indicate that its prevalence will continue to rise, exceeding 44% by 2040.

The term MASLD was recently introduced to replace the former nomenclature for steatotic liver disease (non-alcoholic fatty liver disease, NAFLD) and to emphasize the close relationship between "fatty liver" and metabolic syndrome, as reported in the 2023 multisociety Delphi consensus statement.

MASLD is defined by the accumulation of triglycerides in the liver in the absence of significant alcohol intake or other causes of steatosis, together with at least one of the following cardiometabolic risk factors: obesity, type 2 diabetes mellitus, dyslipidemia, or arterial hypertension. Its pathophysiology is multifactorial and involves both modifiable and non-modifiable factors: liver damage results from the combined effect of metabolic dysfunction, unhealthy diet, physical inactivity, and genetic predisposition.

At present, there is no strong consensus on pharmacological therapy for the management of MASLD. For this reason, lifestyle modification, with a focus on diet and physical activity, still represents the first-line intervention for the prevention and management of MASLD. Recent studies identify diet as a primary modifiable factor in the clinical approach to MASLD, highlighting the key role of diet quality and eating habits in modulating various metabolic processes. Most of the scientific evidence agrees in identifying the Mediterranean diet as the dietary pattern most strongly associated with health benefits, with protective effects against several non-communicable chronic diseases.

The Mediterranean diet is a traditional dietary pattern followed by populations living in countries bordering the Mediterranean Sea. Its benefits are mainly attributable to the characteristic foods it includes, which are rich in nutrients, antioxidant compounds, and dietary fiber. The Mediterranean diet is based on high consumption of fruits, vegetables, whole grains, legumes, nuts, and extra virgin olive oil, moderate intake of fish and poultry, and low intake of red meat and processed products.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • Subjects with BMI < 20 and BMI >
  • 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.

研究组 & 干预措施

Arm A

Experimental

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

干预措施: Oil Supplementation - 3 tablespoons of oil (Dietary Supplement)

Arm B

Experimental

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

干预措施: 9 Tablespoons of Oil (Dietary Supplement)

结局指标

主要结局

The effect of intervention on CAP value (Controlled Attenuation Parameter)

时间窗: 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

时间窗: 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

时间窗: at Baseline and after two months

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

次要结局

  • Change in red blood cell membrane lipidomic profile(at Baseline and after two months)
  • Change in gut microbiota taxonomic profile(at Baseline and after two months)
  • Change in gut microbiota functional profile(at Baseline and after two months)

研究者

发起方
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rossella Tatoli

Dietician

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

研究点 (1)

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