Effects of Two Different Exercise Programs Combined With the Mediterranean Diet on Inflammatory Status in Subjects With Obesity and NAFLD
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The aim of the study is to estimate the effectiveness of two different exercise programs combined with the Mediterranean diet versus diet alone on inflammatory status in subjects aged 18-65 years with obesity (BMI\>30) and Non-Alcoholic Fatty Liver Disease (NAFLD) (CAP \>248 dB/m).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:
• 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)).
Locations
Other Locations
Italy
IRCCS De Bellis
RECRUITING
Castellana Grotte
Contact Information
Primary
Endrit Shahini, MD
endrit.shahini@irccsdebellis.it
00390804994249
Backup
Antonella Bianco
antonella.bianco@irccsdebellis.it
00390804994653
Time Frame
Start Date: 2023-10-02
Estimated Completion Date: 2026-12-23
Participants
Target number of participants: 90
Treatments
Active_comparator: Aerobic Exercise and Mediterranean Diet
Subjects randomized and assigned to this intervention group will follow the low glycaemic index Mediterranean diet and simultaneously perform 180 minutes of moderate-intensity aerobic exercise per week for 4 months. Intervention type: aerobic exercise and Mediterranean diet.
Active_comparator: HITT and Mediterranean Diet
Subjects randomized and assigned to this intervention group will follow the low glycaemic index Mediterranean diet and simultaneously perform 150 minutes per week of high-intensity interval exercise (HITT) in the gym for 4 months. Intervention type: HIIT and Mediterranean diet.
Active_comparator: Mediterranean Diet
Subjects randomized and assigned to this intervention group will follow the low-glycaemic index Mediterranean diet for 4 months. Intervention type: Mediterranean Diet.
Related Therapeutic Areas
Sponsors
Collaborators: Antonella Bianco, Isabella Franco
Leads: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis