NCT05477212

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

Evaluation of Gut Permeability in Patients Affected by Obesity and NAFLD: Influence of Ketogenic Diet on Diagnostic and Prognostic Markers in Liver Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is open label, with one arm only. In this study will be enrolled patients with obesity (BMI more than 30). Aim of the study is to determine the influence (if any) of a very low calorie ketogenic diet (VLCKD) on gut permeability and liver steatosis. The first objective is to examine the influence of obesity on the prevalence and severity of impaired intestinal permeability and hepatic steatosis. Intestinal permeability means the ability of the intestinal barrier to block the passage of substances potentially harmful to our body. The second objective is to evaluate whether a low-calorie and ketogenic dietary intervention, lasting 6 weeks, can change intestinal permeability and hepatic steatosis

Conditions

• Permeability; Increased
• NAFLD
• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ketogenic Diet	all patients will receive a very low calorie ketogenic diet

Timeline

• Start date: 2022-04-28
• Primary completion: 2024-05-28
• Completion: 2025-05-28
• First posted: 2022-07-28
• Last updated: 2024-10-02

Locations

1 site across 1 country: Italy