Protein-rich Diet and NAFLD in Bariatric Surgery
NCT02400099 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2015-03-26
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.
Conditions
- Obesity
- Non-alcoholic Fatty Liver Disease
Interventions
- DIETARY_SUPPLEMENT
-
High-protein low calorie diet
- DIETARY_SUPPLEMENT
-
Control low calorie diet
- OTHER
-
Anthropometrical measurements
- OTHER
-
Body composition
- OTHER
-
8-h metabolic profile
- OTHER
-
Liver biopsy
Sponsors & Collaborators
-
Federico II University
collaborator OTHER -
Catholic University of the Sacred Heart
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-06-30
- Primary Completion
- 2016-06-30
Countries
- Italy
Study Locations
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