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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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). Who Should NOT Join This Trial: - Normal weight and underweight subjects - Presence of any pathology that could influence the presence of steatosis apart from the pathologies that represent inclusion criteria - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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). Exclusion Criteria: * Normal weight and underweight subjects * Presence of any pathology that could influence the presence of steatosis apart from the pathologies that represent inclusion criteria * 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

Treatments Being Tested

OTHER

Mediterranean 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.

Locations (1)

Irccs Saverio de Bellis
Castellana Grotte, BARI, Italy