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 December 22, 2024

Not yet recruiting

Keywords

Obesity Liver Diseases

ClinConnect Summary

Interventional, randomized, controlled 2-arm clinical trial

The two study arms are:

* Low-Glycemic Index Mediterranean Diet (Control Arm).
* IF 14/10 (Experimental Arm) with 14 hours of overnight fasting and 10 hours of feeding with Low Glycemic Index Mediterranean Diet.

The study involves the enrollment of 60 subjects (30 in each arm) with NAFLD, medium/severe grade diagnosed by Fibroscan, randomly assigned using randomization tables to one of the two study arms.

The duration of the nutritional intervention is 4 months. During the study duration period, patients will undergo 3 visits.
...

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

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0