Evaluating the effects of a ketogenic diet on gut permeability in obese patients with NAFLD
Evaluation of Gut Permeability in Patients Affected by Obesity and NAFLD: Influence of Ketogenic Diet on Diagnostic and Prognostic Markers in Liver Disease
This study is testing if a very low-calorie ketogenic diet can improve gut health and liver fat in obese patients with non-alcoholic fatty liver disease over six weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis Academic / other |
| Locations | 1 site (Castellana Grotte, BARI) |
| Trial ID | NCT05477212 on ClinicalTrials.gov |
What this trial studies
This open-label, one-arm study aims to enroll patients with obesity (BMI over 30) to assess the impact of a very low-calorie ketogenic diet (VLCKD) on gut permeability and liver steatosis over a 6-week period. The study will first examine how obesity affects intestinal permeability and hepatic steatosis severity. The second objective is to determine if the ketogenic dietary intervention can improve these conditions. Participants will be monitored for changes in their intestinal barrier function and liver fat content.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a BMI of 30 or higher and diagnosed hepatic steatosis.
Not a fit: Patients who are normal weight or underweight, or those with conditions affecting intestinal permeability or liver metabolism, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary interventions that improve gut health and liver function in obese patients with NAFLD.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have indicated potential benefits of ketogenic diets in managing obesity and related metabolic conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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 features that 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 recognized criteria (FLI - Fatty Liver Index , FIB-4 - Fibrosis-4 index, NFS - NAFLD fibrosis score). Exclusion Criteria: 1. Normal and underweight subjects 2. Presence of any pathology that may affect the presence of altered intestinal permeability or steatosis, apart from pathologies that represent inclusion criteria 3. Treatment with any device, pharmacological or not, that can affect intestinal permeability and liver metabolism and, therefore, the presence of steatosis 4. Pregnancy or lactation
Where this trial is running
Castellana Grotte, BARI
- Irccs Saverio de Bellis — Castellana Grotte, Bari, Italy (Recruiting)
Study contacts
- Principal investigator: Giovanni De Pergola, Prof — IRCCS "Saverio de Bellis"
- Study coordinator: Giovanni De Perogla, Prof
- Email: giovanni.depergola@irccsdebellis.it
- Phone: 0804994635
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.