Protein-rich Diet and NAFLD in Bariatric Surgery
Not Applicable
- Conditions
- ObesityNon-alcoholic Fatty Liver Disease
- Registration Number
- NCT02400099
- Lead Sponsor
- Catholic University of the Sacred Heart
- Brief Summary
Randomized, single-blind, trial to determine whether a high-protein, low calorie diet is more effective than a control low calorie diet in improving the metabolic and histologic abnormalities in patients with Non-alcoholic Fatty Liver Disease undergoing bariatric surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Morbidly obese subjects with a BMI >40 kg/m2 who are eligible for bariatric surgery and have accepted to undergo RYGB
- Weight stable for at least 6 months before the study (+/- 5 kg within the previous 6 months)
- Stable medication
- Provision of informed consent
Exclusion Criteria
- Patients not eligible for laparoscopic RYGB
- Incapacity to give a valid informed consent or unwilling to give the consent
- Pregnancy or lactating
- Type 2-diabetes mellitus
- Significant illness within the two weeks preceding surgery, as judged by the physician.
- Obvious infection (bacteria, virus etc)
- Major cardiovascular disease
- Major gastrointestinal, respiratory, or any hormonal disorders
- History of drug addiction and/or alcohol use
- Suspected or confirmed poor compliance
- Alcohol consumption of > 20 g per day in the case of women and > 30 g per day in the case of men for at least 3 consecutive months during the previous 5 years
- Presence of hepatitis C or frank cirrhosis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Liver fat content assessment 1 year
- Secondary Outcome Measures
Name Time Method fat free mass assessment 1 year Insulin sensitivity assessment 1 year
Trial Locations
- Locations (1)
Catholic University School of Medicine
🇮🇹Rome, Italy
Catholic University School of Medicine🇮🇹Rome, Italy