Mediterranean diet and exercise for treating fatty liver disease and inflammation
Influence of a Different Percentage of Nutrients on the Effects of a Low-calorie Mediterranean Diet Associated With Physical Exercise on the Parameters of Steatosis, Intestinal Function and Metabolic Risk in Patients With Obesity and NAFLD
This study is testing if two different Mediterranean diet plans along with exercise can help people with obesity and fatty liver disease feel better and improve their health over three months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis Academic / other |
| Locations | 1 site (Castellana Grotte, Bari) |
| Trial ID | NCT06275906 on ClinicalTrials.gov |
What this trial studies
This interventional study evaluates the effects of two Mediterranean Diet models, differing in carbohydrate and lipid percentages, combined with a moderate-intensity aerobic exercise program on patients with obesity and non-alcoholic fatty liver disease (NAFLD). Over a period of three months, the study aims to assess changes in hepatic steatosis, inflammation markers, metabolic risk factors, body composition, intestinal microbiota, and symptoms of irritable bowel syndrome (IBS). The study is designed to provide insights into lifestyle interventions as a means to manage NAFLD and related conditions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with a BMI of 30 or higher and a diagnosis of hepatic steatosis.
Not a fit: Patients who are normal weight, underweight, or have conditions affecting liver metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve liver health and reduce inflammation in patients with NAFLD and obesity.
How similar studies have performed: Previous studies have shown the Mediterranean diet's effectiveness in improving NAFLD, suggesting a promising approach in this context.
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 characterize metabolic syndrome * Age range between 18 and 60 years, both sexes * Diagnosis of hepatic steatosis, formulated on the basis of recognized criteria (fibroscan \[CAP (controlled attenuation parameter) \> 238 dB/m\], FLI). Exclusion Criteria: * Normal weight and underweight subjects * Presence of any pathology that could influence the presence of steatosis apart from the pathologies that represent inclusion criteria * Treatment with any device, pharmacological or otherwise, which can influence hepatic metabolism and, therefore, the presence of steatosis * Pregnancy or breastfeeding * Subjects with osteo-articular pathologies that may prevent regular physical exercise
Where this trial is running
Castellana Grotte, Bari
- Irccs Saverio de Bellis — Castellana Grotte, Bari, Italy (Recruiting)
Study contacts
- Study coordinator: Giovanni De PErgola, MD
- Email: giovanni.depergola@irccsdebellis.it
- Phone: 0804994653
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.