Protein-rich Diet and NAFLD in Bariatric Surgery

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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Non-alcoholic Fatty Liver Disease
• Intervention / Treatment: Dietary supplement: High-protein low calorie diet; Other: Anthropometrical measurements; Other: Body composition; Other: 8-h metabolic profile; Other: Liver biopsy; Dietary supplement: Control low calorie diet

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Catholic University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Liver fat content assessment	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart
• Collaborators: Federico II University

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: March 23, 2015
• First Posted (Estimate): March 26, 2015

Study Record Updates

• Last Update Posted (Estimate): March 26, 2015
• Last Update Submitted That Met QC Criteria: March 23, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: UCSC-2015