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NCT06275906: NAFLD-POS5

Influence of a Mediterranean Diet Combined With a Physical Activity Intervention, on NAFLD and Inflammation Parameters.

Recruiting now NA Last updated 16 May 2024
What this trial tests

NA trial testing Mediterranean diet and moderate intensity physical exercise (outdoor walking). in NAFLD in 60 participants. Currently enrolling.

Timeline
19 March 2024
Primary endpoint
8 April 2025
8 April 2026

Quick facts

Lead sponsorAzienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment60
Start date19 March 2024
Primary completion8 April 2025
Estimated completion8 April 2026
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Who can join

Adults 18 to 60, any sex, with NAFLD or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for NAFLD

Currently open trials in the same condition.

Other Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06275906.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing