Effects of Two Different Exercise Programs and Diet in Obese Subjects With NAFLD
Launched by AZIENDA OSPEDALIERA SPECIALIZZATA IN GASTROENTEROLOGIA SAVERIO DE BELLIS · Dec 15, 2023
Trial Information
Current as of July 21, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how two different exercise programs, combined with the Mediterranean diet, compare to just following the diet alone in helping people with obesity and a liver condition called Non-Alcoholic Fatty Liver Disease (NAFLD). The study aims to see if these programs can improve inflammation in participants aged 18 to 65 who are overweight (with a body mass index over 30) and have a specific level of fat in their liver, measured by a test called Fibroscan.
To be eligible for this trial, participants must be between 18 and 65 years old, have a high body weight or waist size, and have been diagnosed with fatty liver disease. People who are underweight, pregnant, or have certain health conditions that could affect their ability to exercise or the results of the study won't be able to join. Those who participate can expect to engage in different exercise routines and follow a healthy diet, while being monitored for their health and inflammation levels throughout the study. This trial is currently recruiting participants who meet the criteria and are interested in improving their health.
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 characterise metabolic syndrome
- • Age range 18-65 years, both sexes
- • Diagnosis of hepatic steatosis, formulated on the basis of recognised criteria (fibroscan (CAP (controlled attenuation parameter) \> 238 dB/m)).
- Exclusion Criteria:
- • Normal and underweight subjects
- • Presence of any pathology that may influence the presence of steatosis apart from pathologies that are inclusion criteria, neurological and psychiatric pathologies, gastrointestinal, oncological and cardiovascular diseases
- • Pregnancy or breastfeeding
- • Subjects with osteoarticular pathologies that may prevent regular exercise
- • Inability to quantify the degree of NAFLD by Fibroscan
- • Person not in possession of a medical certificate of fitness for non-competitive physical activity.
About Azienda Ospedaliera Specializzata In Gastroenterologia Saverio De Bellis
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio De Bellis is a leading healthcare institution dedicated to advancing the field of gastroenterology through innovative clinical research and patient-centered care. Renowned for its specialized services and comprehensive treatment options, the hospital is committed to improving patient outcomes and enhancing the understanding of gastrointestinal disorders. With a focus on rigorous clinical trials, the institution collaborates with multidisciplinary teams to explore new therapies and diagnostic methods, ensuring that it remains at the forefront of gastroenterological advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Castellana Grotte, Bari, Italy
Patients applied
Trial Officials
Endrit Shahini, MD
Principal Investigator
IRCCS Saverio de Bellis
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported