Back to resultsProtein-rich Diet and NAFLD in Bariatric Surgery
Primary Purpose
Obesity, Non-alcoholic Fatty Liver Disease
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
High-protein low calorie diet
Control low calorie diet
Anthropometrical measurements
Body composition
8-h metabolic profile
Liver biopsy
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
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.
Sites / Locations
- Catholic University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
High-protein low calorie diet (HPLC)
Control low calorie diet (CLC)
Arm Description
900 Kcal; Protein 90 g (39%); CHO 75 g (30%); Lipid 32 g (31%)
900 Kcal; Protein. 50 g (22%); CHO 119 g (48%); Lipid 31 g (30%)
Outcomes
Primary Outcome Measures
Liver fat content assessment
Secondary Outcome Measures
Insulin sensitivity assessment
fat free mass assessment
Full Information
NCT ID
NCT02400099
First Posted
March 23, 2015
Last Updated
March 23, 2015
Sponsor
Catholic University of the Sacred Heart
Collaborators
Federico II University
1. Study Identification
Unique Protocol Identification Number
NCT02400099
Brief Title
Protein-rich Diet and NAFLD in Bariatric Surgery
Official Title
Protein-rich Diet and Non-Alcoholic Fatty Liver Disease in Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart
Collaborators
Federico II University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Non-alcoholic Fatty Liver Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High-protein low calorie diet (HPLC)
Arm Type
Active Comparator
Arm Description
900 Kcal; Protein 90 g (39%); CHO 75 g (30%); Lipid 32 g (31%)
Arm Title
Control low calorie diet (CLC)
Arm Type
Placebo Comparator
Arm Description
900 Kcal; Protein. 50 g (22%); CHO 119 g (48%); Lipid 31 g (30%)
Intervention Type
Dietary Supplement
Intervention Name(s)
High-protein low calorie diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Control low calorie diet
Intervention Type
Other
Intervention Name(s)
Anthropometrical measurements
Intervention Type
Other
Intervention Name(s)
Body composition
Intervention Type
Other
Intervention Name(s)
8-h metabolic profile
Intervention Type
Other
Intervention Name(s)
Liver biopsy
Primary Outcome Measure Information:
Title
Liver fat content assessment
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Insulin sensitivity assessment
Time Frame
1 year
Title
fat free mass assessment
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geltrude Mingrone, Professor
Phone
0630154395
Ext
0039
Email
gmingrone@rm.unicatt.it
Facility Information:
Facility Name
Catholic University School of Medicine
City
Rome
ZIP/Postal Code
00168
Country
Italy
12. IPD Sharing Statement
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Protein-rich Diet and NAFLD in Bariatric Surgery
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