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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study completion date: May 28, 2024 to May 28, 2025v4
  2. Primary and study completion dates: May 28, 2023 to May 28, 2024v3
  3. Primary completion date: Sep 30, 2022 to May 28, 2023
    • Study completion date: Oct 30, 2022 to May 28, 2023
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT05477212
Lead Sponsor Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Collaborators: Francesco Russo, Giuseppe, Riezzo, Michele, Linsalata, Antonella, Orlando, Benedetta, D Attoma, Laura, Prospero, Antonia, Ignazzi, Sara, De Nucci, Raffaele, Cozzolongo, Vito, Giannuzzi, Maria, De Angelis, Giusy Rita, Caponio, Oronzo, Milella, Gianluigi, Giannelli
Conditions
(from sponsor)		 Permeability; Increased, NAFLD, Obesity
Related terms Non-alcoholic Fatty Liver Disease, Obesity
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov