Protein-rich Diet and NAFLD in Bariatric Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Protein-rich Diet and Non-Alcoholic Fatty Liver Disease in Bariatric Surgery

Conditions
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Obesity, Non-alcoholic Fatty Liver Disease

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High-protein low calorie diet (HPLC)<br>900 Kcal; Protein 90 g (39%); CHO 75 g (30%); Lipid 32 g (31%) | Dietary Supplement: High-protein low calorie diet<br> <br> Other: Anthropometrical measurements<br> <br> Other: Body composition<br> <br> Other: 8-h metabolic profile<br> <br> Other: Liver biopsy<br> <br> |
| Placebo Comparator: Control low calorie diet (CLC)<br>900 Kcal; Protein. 50 g (22%); CHO 119 g (48%); Lipid 31 g (30%) | Dietary Supplement: Control low calorie diet<br> <br> Other: Anthropometrical measurements<br> <br> Other: Body composition<br> <br> Other: 8-h metabolic profile<br> <br> Other: Liver biopsy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver fat content assessment |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity assessment |  | 1 year | 
| fat free mass assessment |  | 1 year |