Status:
RECRUITING
Effects of Two Different Exercise Programs and Diet in Obese Subjects With NAFLD
Lead Sponsor:
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Collaborating Sponsors:
Antonella Bianco
Isabella Franco
Conditions:
Obesity
NAFLD
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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...
Detailed Description
The main objective of the study is to estimate the effect of two exercise programs of different type and intensity combined with a Low Glycaemic Index Mediterranean Diet (LGIMD) compared to diet alone...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 23 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06186869
Start Date
October 2 2023
End Date
December 23 2026
Last Update
May 1 2025
Active Locations (1)
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1
IRCCS De Bellis
Castellana Grotte, Bari, Italy, 70013