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

NCT05477212 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-10-02

No results posted yet for this 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

Conditions

  • Permeability; Increased
  • NAFLD
  • Obesity

Interventions

DIETARY_SUPPLEMENT

Ketogenic Diet

all patients will receive a very low calorie ketogenic diet

Sponsors & Collaborators

  • Francesco Russo

    collaborator UNKNOWN

  • Giuseppe, Riezzo

    collaborator UNKNOWN

  • Michele, Linsalata

    collaborator UNKNOWN

  • Antonella, Orlando

    collaborator UNKNOWN

  • Benedetta, D Attoma

    collaborator UNKNOWN

  • Laura, Prospero

    collaborator UNKNOWN

  • Antonia, Ignazzi

    collaborator UNKNOWN

  • Sara, De Nucci

    collaborator UNKNOWN

  • Raffaele, Cozzolongo

    collaborator UNKNOWN

  • Vito, Giannuzzi

    collaborator UNKNOWN

  • Maria, De Angelis

    collaborator UNKNOWN

  • Giusy Rita, Caponio

    collaborator UNKNOWN

  • Oronzo, Milella

    collaborator UNKNOWN

  • Gianluigi, Giannelli

    collaborator UNKNOWN

  • Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

    lead OTHER

Principal Investigators

  • Giovanni De Pergola, Prof · IRCCS "Saverio de Bellis"

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-28
Primary Completion
2024-05-28
Completion
2025-05-28

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05477212 on ClinicalTrials.gov