Influence of a Mediterranean Diet Combined With a Physical Activity Intervention, on NAFLD and In… (NCT06275906) | Clinical Trial Compass
CompletedNot Applicable
Influence of a Mediterranean Diet Combined With a Physical Activity Intervention, on NAFLD and Inflammation Parameters.
Italy36 participantsStarted 2024-03-19
Plain-language summary
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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The effect of intervention on CAP value
Timeframe: at Baseline and after 90 days
2
The effect of intervention on FLI value
Timeframe: at Baseline and after 90 days
3
The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis, nutritional status, inflammatory status and metabolic and cardiovascular risk
Timeframe: at Baseline and after 90 days
4
The effect of the intervention on the integrity of the intestinal barrier
Timeframe: at Baseline and after 90 days
Trial details
NCT IDNCT06275906
SponsorAzienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis