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

Launched by AZIENDA OSPEDALIERA SPECIALIZZATA IN GASTROENTEROLOGIA SAVERIO DE BELLIS · Feb 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how following a Mediterranean diet, combined with regular moderate exercise, can help people with obesity and non-alcoholic fatty liver disease (NAFLD). The researchers want to see if these lifestyle changes can improve liver health, reduce inflammation, and help with symptoms of irritable bowel syndrome (IBS) in just three months. They are comparing two different versions of the Mediterranean diet, which vary in their carbohydrate and fat content, to find out which is more effective.

To join the study, participants should be between 18 and 60 years old, have a body mass index (BMI) of 30 or more (which indicates obesity), and have a confirmed diagnosis of fatty liver. However, people who are of normal weight, pregnant, or have certain health conditions that might affect their liver or ability to exercise won't be eligible. If you participate, you can expect to adopt a new diet and exercise routine, and you will be monitored for changes in your liver health and overall well-being during the trial. This study is currently looking for participants, so it's a great opportunity for those who qualify!

Gender

ALL

Eligibility criteria

• 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