Evaluation of Gut Permeability in Patients Affected by Obesity and NAFLD: Influence of Ketogenic Diet.

Launched by AZIENDA OSPEDALIERA SPECIALIZZATA IN GASTROENTEROLOGIA SAVERIO DE BELLIS · Jul 25, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how a very low-calorie ketogenic diet (VLCKD) affects gut health and liver fat in people with obesity and a condition called non-alcoholic fatty liver disease (NAFLD). The study aims to understand if obesity impacts the ability of the gut to protect against harmful substances and how the ketogenic diet might help improve this gut barrier and reduce liver fat over a period of six weeks.

To participate, you need to be 18 to 70 years old, have a body mass index (BMI) of 30 or higher, or have a larger waist measurement if you're a man or woman. You also need to have been diagnosed with liver fat using specific tests. Unfortunately, those who are underweight, pregnant, or have certain health issues that could interfere with the study won't be able to join. If you do participate, you can expect to follow the low-calorie ketogenic diet and help researchers learn how diet impacts gut and liver health in individuals with obesity.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. BMI ≥ 30 Kg/m2 or abdominal circumference (waist) \>94 cm in men and \>80 cm in women (IDF criteria for the definition of abdominal obesity) with or without the features that characterize the metabolic syndrome
• • 2. Age range between 18 and 70 years, both sexes
• • 3. Diagnosis of hepatic steatosis, formulated on the basis of fibroscan \[CAP (controlled attenuation parameter) \> 238 dB/m(decibel/meter)\], and other recognized criteria (FLI - Fatty Liver Index , FIB-4 - Fibrosis-4 index, NFS - NAFLD fibrosis score).
• Exclusion Criteria:
• • 1. Normal and underweight subjects
• • 2. Presence of any pathology that may affect the presence of altered intestinal permeability or steatosis, apart from pathologies that represent inclusion criteria
• • 3. Treatment with any device, pharmacological or not, that can affect intestinal permeability and liver metabolism and, therefore, the presence of steatosis
• • 4. Pregnancy or lactation