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

Last updated: October 1, 2024
Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Obesity

Liver Disease

Treatment

Ketogenic Diet

Clinical Study ID

NCT05477212
NAFLDdietachetogenica
  • Ages 18-65
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 featuresthat 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 recognizedcriteria (FLI - Fatty Liver Index , FIB-4 - Fibrosis-4 index, NFS - NAFLD fibrosisscore).

Exclusion

Exclusion Criteria:

  1. Normal and underweight subjects

  2. Presence of any pathology that may affect the presence of altered intestinalpermeability or steatosis, apart from pathologies that represent inclusion criteria

  3. Treatment with any device, pharmacological or not, that can affect intestinalpermeability and liver metabolism and, therefore, the presence of steatosis

  4. Pregnancy or lactation

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Ketogenic Diet
Phase:
Study Start date:
April 28, 2022
Estimated Completion Date:
May 28, 2025

Connect with a study center

  • Irccs Saverio de Bellis

    Castellana Grotte, Bari 70013
    Italy

    Active - Recruiting

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