Protein-rich Diet and NAFLD in Bariatric Surgery

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02400099
• Other study ID #: UCSC-2015
• Status: Not yet recruiting
• Phase: N/A
• First received: March 23, 2015
• Last updated: March 23, 2015
• Start date: June 2015

Study information

• Verified date: March 2015
• Source: Catholic University of the Sacred Heart
• Contact: Geltrude Mingrone, Professor
• Phone: 0630154395
• Email: gmingrone[@]rm.unicatt.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Obesity

Intervention

Dietary Supplement:
• High-protein low calorie diet

• Control low calorie diet

Other:
• Anthropometrical measurements

• Body composition

• 8-h metabolic profile

• Liver biopsy

Locations

Country	Name	City	State
Italy	Catholic University School of Medicine	Rome

Sponsors (2)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart	Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver fat content assessment		1 year	Yes
Secondary	Insulin sensitivity assessment		1 year	Yes
Secondary	fat free mass assessment		1 year	Yes