RecruitingNot ApplicableNCT06275906

Influence of a Mediterranean Diet Combined With a Physical Activity Intervention, on NAFLD and Inflammation Parameters.

Influence of a Different Percentage of Nutrients on the Effects of a Low-calorie Mediterranean Diet Associated With Physical Exercise on the Parameters of Steatosis, Intestinal Function and Metabolic Risk in Patients With Obesity and NAFLD

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Enrollment

60 participants

Start Date

Mar 19, 2024

Study Type

INTERVENTIONAL

Conditions

Obesity NAFLD IBS

Summary

The study in question is an interventional study with nutritional intervention. The aim of the study is to evaluate whether the adoption of two different models of Mediterranean Diet, based on the different percentage of carbohydrates and lipids, associated with a program of moderate intensity aerobic physical exercise, in patients with obesity and NAFLD can exercise, after only 3 months, effects on: * specific aspects associated with NAFLD, such as the degree of hepatic steatosis and fibrosis; * circulating levels of molecules correlated with the degree of generalized and hepatic inflammation and the blood concentrations of metabolic and cardiovascular risk factors associated with abdominal obesity; * intestinal barrier; * body composition; * intestinal microbiota; * symptoms of IBS (irritable bowel syndrome) in patients with NAFLD.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria6

BMI ≥ 30 Kg/m2 or an abdominal circumference (waist) > 94 cm in men and > 80 cm in women (IDF criteria for the definition of abdominal obesity) with or without the characteristics that characterize metabolic syndrome
Age range between 18 and 60 years, both sexes
Diagnosis of hepatic steatosis, formulated on the basis of recognized criteria (fibroscan \[CAP (controlled attenuation parameter) > 238 dB/m\], FLI).
Treatment with any device, pharmacological or otherwise, which can influence hepatic metabolism and, therefore, the presence of steatosis
Pregnancy or breastfeeding
Subjects with osteo-articular pathologies that may prevent regular physical exercise

Exclusion Criteria1

Normal weight and underweight subjects

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Interventions

OTHERMediterranean diet and moderate intensity physical exercise (outdoor walking).

Mediterranean Diet, based on the different percentage of carbohydrates and lipids, associated with a program of moderate intensity aerobic physical exercise (outdoor walking), in patients with obesity and NAFLD.