NCT05477212 Evaluation of Gut Permeability in Patients Affected by Obesity and NAFLD: Influence of Ketogenic Diet.
| NCT ID | NCT05477212 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis |
| Condition | Permeability; Increased |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-04-28 |
| Primary Completion | 2024-05-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2022-04-28 with a primary completion date of 2024-05-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Giovanni De Pergola, Prof
PRINCIPAL INVESTIGATOR
IRCCS "Saverio de Bellis"
Frequently Asked Questions
Who can join the NCT05477212 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Permeability; Increased. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05477212 currently recruiting?
Yes, NCT05477212 is actively recruiting participants. Contact the research team at giovanni.depergola@irccsdebellis.it for enrollment information.
Where is the NCT05477212 trial being conducted?
This trial is being conducted at Castellana Grotte, Italy.
Who is sponsoring the NCT05477212 clinical trial?
NCT05477212 is sponsored by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis. The principal investigator is Giovanni De Pergola, Prof at IRCCS "Saverio de Bellis". The trial plans to enroll 30 participants.