Comparing exercise programs and diet for obese individuals with liver disease
Effects of Two Different Exercise Programs Combined With the Mediterranean Diet on Inflammatory Status in Subjects With Obesity and NAFLD
NA · Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · NCT06186869
This study is testing whether combining exercise programs with a special diet can help obese people with liver disease feel better and reduce inflammation compared to just following the diet alone.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis (other) |
| Locations | 1 site (Castellana Grotte, Bari) |
| Trial ID | NCT06186869 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are obese individuals aged 18-65 with a BMI over 30 and a diagnosis of hepatic steatosis.
Not a fit: Patients who are normal weight, underweight, or have other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective lifestyle interventions to reduce inflammation and improve health in obese patients with NAFLD.
How similar studies have performed: Other studies have shown positive outcomes with exercise and dietary interventions in similar populations, suggesting this approach is promising.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Castellana Grotte, Bari
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, NAFLD, Physical Exercise, systemic inflammation