Effects of Two Different Exercise Programs and Diet in Obese Subjects With NAFLD
Recruiting · NCT06186869 · Interventional (participants receive a specific treatment) · Lead sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
View the official record on ClinicalTrials.gov →Interventions studied
Aerobic Exercise and diet interventionDietHiit and diet intervention
What this trial is about
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).
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- IRCCS De Bellis - Castellana Grotte, Bari, Italy