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Search / Trial NCT06615817

Intermittent Fasting, Mediterranean Diet and NAFLD

Launched by AZIENDA OSPEDALIERA SPECIALIZZATA IN GASTROENTEROLOGIA SAVERIO DE BELLIS · Sep 23, 2024

Trial Information

Current as of July 26, 2025

Not yet recruiting

Keywords

Obesity Liver Diseases

ClinConnect Summary

This clinical trial is studying two different eating plans to see how they affect a condition called Non-Alcoholic Fatty Liver Disease (NAFLD). The trial will compare Intermittent Fasting, which involves eating during a specific 10-hour window each day, with a Low Glycemic Index Mediterranean Diet, known for being healthy and balanced. The goal is to find out which approach is better for managing NAFLD and possibly helping with obesity.

To participate in this trial, you need to have medium to severe NAFLD and a body mass index (BMI) between 25 and 35, which means you may be overweight but not extremely so. Unfortunately, some people won't be eligible, including those with certain diabetes treatments, alcohol-related liver issues, or serious health conditions that could complicate their participation. If you join the study, you'll be guided on how to follow one of the diets and monitored for how your liver health changes over time. This research is an exciting opportunity to learn more about managing NAFLD with dietary changes!

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Medium/severe NAFLD (CAP\>268)
  • BMI between 25 and 35
  • Exclusion Criteria:
  • diabetes treated with insulin,
  • fatty liver disease linked to alcohol consumption,
  • chronic inflammatory intestinal and oncological diseases,
  • visceral obesity which does not allow good resolution of Fibroscan images,
  • subjects in serious medical conditions that may compromise participation in the trial,
  • people following a special diet or unable to follow a diet for religious or other reasons.
  • Pregnancy and breastfeeding

About Azienda Ospedaliera Specializzata In Gastroenterologia Saverio De Bellis

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio De Bellis is a leading healthcare institution dedicated to advancing the field of gastroenterology through innovative clinical research and patient-centered care. Renowned for its specialized services and comprehensive treatment options, the hospital is committed to improving patient outcomes and enhancing the understanding of gastrointestinal disorders. With a focus on rigorous clinical trials, the institution collaborates with multidisciplinary teams to explore new therapies and diagnostic methods, ensuring that it remains at the forefront of gastroenterological advancements.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported