Comparing exercise programs and diet for obese individuals with liver disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of two different exercise programs combined with a Low Glycaemic Index Mediterranean Diet (LGIMD) versus diet alone on inflammatory markers in obese individuals aged 18-65 with Non-Alcoholic Fatty Liver Disease (NAFLD). Participants will engage in either moderate-intensity outdoor walking or High-Intensity Interval Training (HIIT) over a 4-month period. The study will measure changes in systemic inflammation, body composition, physical fitness, gut microbiota, and quality of life. The goal is to determine which intervention is more effective in reducing inflammation and improving overall health outcomes.

Why it matters

Who can join: the full rules

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's running

• IRCCS De Bellis
  Castellana Grotte, Bari, Italy Recruiting

Study contacts

• Principal investigator: Endrit Shahini, MD — IRCCS Saverio de Bellis
• Study coordinator: Endrit Shahini, MD
• Email: endrit.shahini@irccsdebellis.it
• Phone: 00390804994249

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.