NCT06275906Completed
Influence of a Mediterranean Diet Combined With a Physical Activity Intervention, on NAFLD and Inflammation Parameters.
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
Source: ClinicalTrials.gov · Last updated 20 Apr 2026
Brief summary (registry, in English)
The study in question is an interventional study with nutritional intervention. The aim of the study is to evaluate whether the adoption of two different models of Mediterranean Diet, based on the different percentage of carbohydrates and lipids, associated with a program of moderate intensity aerobic physical exercise, in patients with obesity and NAFLD can exercise, after only 3 months, effects on: * specific aspects associated with NAFLD, such as the degree of hepatic steatosis and fibrosis; * circulating levels of molecules correlated with the degree of generalized and hepatic inflammation and the blood concentrations of metabolic and cardiovascular risk factors associated with abdominal obesity; * intestinal barrier; * body composition; * intestinal microbiota; * symptoms of IBS (irritable bowel syndrome) in patients with NAFLD.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 5 Feb 2024
- Start date
- 19 Mar 2024
- Primary completion date
- 8 Apr 2025
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06275906
What you commit to
- Study type: Interventional
- Participants enrolled: 36
- From 19 Mar 2024 to the primary completion date, 8 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with any device, pharmacological or otherwise, which can influence hepatic metabolism and, therefore, the presence of steatosis
Other
- Normal weight and underweight subjects
- Presence of any pathology that could influence the presence of steatosis apart from the pathologies that represent inclusion criteria
- Pregnancy or breastfeeding
- Subjects with osteo-articular pathologies that may prevent regular physical exercise
Who the study is looking for
- 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).
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS "Saverio de Bellis" Coordinator of this site? Confirm its status | Castellana Grotte | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.