Evaluation of Gut Permeability in Patients Affected by Obesity and NAFLD: Influence of Ketogenic Diet.
Recruiting now · Not applicable
Conditions studied: Permeability; Increased, NAFLD, Obesity
In brief
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
Key facts
- Study ID
- NCT05477212
- Run by
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- People needed
- 30
- Starts
- 2022-04-28
- Expected to finish
- 2025-05-28
- Last updated by the study team
- 2024-10-02
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Age range between 18 and 70 years, both sexes
- 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).
You may not qualify if…
- Normal and underweight subjects
- Presence of any pathology that may affect the presence of altered intestinal permeability or steatosis, apart from pathologies that represent inclusion criteria
- Treatment with any device, pharmacological or not, that can affect intestinal permeability and liver metabolism and, therefore, the presence of steatosis
- Pregnancy or lactation
Where it is running
- Irccs Saverio de Bellis — Castellana Grotte, BARI, Italy (enrolling)
Full record on ClinicalTrials.gov
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