Actively Recruiting
Evaluation of Gut Permeability in Patients Affected by Obesity and NAFLD: Influence of Ketogenic Diet.
Led by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · Updated on 2024-10-02
30
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
Sponsors
A
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Lead Sponsor
F
Francesco Russo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of Gut Permeability in Patients Affected by Obesity and NAFLD: Influence of Ketogenic Diet.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- BMI of 30 or higher or abdominal circumference over 94 cm in men and over 80 cm in women
- Age between 18 and 70 years, any gender
- Diagnosis of hepatic steatosis based on fibroscan with CAP > 238 dB/m or other recognized criteria like Fatty Liver Index, Fibrosis-4 index, or NAFLD fibrosis score
You will not qualify if you...
- Normal weight or underweight individuals
- Any disease affecting intestinal permeability or liver steatosis except those included in the criteria
- Use of any treatment or device affecting intestinal permeability or liver metabolism
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Irccs Saverio de Bellis
Castellana Grotte, BARI, Italy, 70013
Actively Recruiting
Research Team
G
Giovanni De Perogla, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here