Protein-rich Diet and NAFLD in Bariatric Surgery

Not Applicable

• 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

• 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

Study Timeline

• Status Verified: 2015-03
• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-23
• Last Update Submitted: 2015-03-23
• Study First Posted: 2015-03-26
• Last Update Posted: 2015-03-26
• Study Start: 2015-06
• Primary Completion: 2016-06

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

Arm && Interventions

Group	Intervention	Description
High-protein low calorie diet (HPLC)	Liver biopsy	900 Kcal; Protein 90 g (39%); CHO 75 g (30%); Lipid 32 g (31%)
Control low calorie diet (CLC)	Body composition	900 Kcal; Protein. 50 g (22%); CHO 119 g (48%); Lipid 31 g (30%)
High-protein low calorie diet (HPLC)	High-protein low calorie diet	900 Kcal; Protein 90 g (39%); CHO 75 g (30%); Lipid 32 g (31%)
High-protein low calorie diet (HPLC)	Anthropometrical measurements	900 Kcal; Protein 90 g (39%); CHO 75 g (30%); Lipid 32 g (31%)
High-protein low calorie diet (HPLC)	Body composition	900 Kcal; Protein 90 g (39%); CHO 75 g (30%); Lipid 32 g (31%)
Control low calorie diet (CLC)	Control low calorie diet	900 Kcal; Protein. 50 g (22%); CHO 119 g (48%); Lipid 31 g (30%)
Control low calorie diet (CLC)	Anthropometrical measurements	900 Kcal; Protein. 50 g (22%); CHO 119 g (48%); Lipid 31 g (30%)
Control low calorie diet (CLC)	8-h metabolic profile	900 Kcal; Protein. 50 g (22%); CHO 119 g (48%); Lipid 31 g (30%)
Control low calorie diet (CLC)	Liver biopsy	900 Kcal; Protein. 50 g (22%); CHO 119 g (48%); Lipid 31 g (30%)
High-protein low calorie diet (HPLC)	8-h metabolic profile	900 Kcal; Protein 90 g (39%); CHO 75 g (30%); Lipid 32 g (31%)

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