A Pilot Study on Whey Protein Supplementation in Non Alcoholic Fatty Liver Disease

Obesity Clinical Trial

— PROTOB  

Official title:

Effect of a Whey Protein Supplementation on Intrahepatic Lipids in Obese Patients With Non-alcoholic Fatty Liver Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870077
• Other study ID #: Protobese
• Status: Completed
• Phase: N/A
• First received: March 25, 2009
• Last updated: February 23, 2012
• Start date: April 2009
• Est. completion date: April 2010

Study information

• Verified date: February 2012
• Source: University of Lausanne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

An increase in dietary protein intake has been shown to blunt the increase in intrahepatic fat induced by high fat feeding in healthy individuals. The purpose of this study is to determine if a protein supplementation decreases intrahepatic fat in obese patients with non-alcoholic fatty liver disease.

Description:

12 obese patients will be be treated with a dietary whey protein supplementation over 4 weeks. Their intrahepatic fat content, glucose tolerance, and body weight will be evaluated before and after 4 weeks of supplementation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• BMI higher than 35 kg/m2

• age 18-50 years

• sex male or female

• ASAT/ALAT > 1.8

Exclusion Criteria:

• treatment with hypolemic or antidiabetic agents

• blood glucose > 7 mmol/l

• alcohol intake > 20g/day

• creatinin > 120 umol/l)

• contra-indications to Magnetic resonnance imaging

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• ProWHEY 94 CFM, SponserR
3 times 20g per day

Locations

Country	Name	City	State
Switzerland	Centre d'investigations cliniques "cardiomet"/ CHUV	Lausanne	VD

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intrahepatic fat		before and after 4 weeks of whey protein supplementation	No
Secondary	glucose metabolism		4-hour oral glucose tolerance test with indirect calorimetry	No
Secondary	body weight and body fat		before and after 4 weeks whey protein supplementation	No