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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00870077
Recruitment Status : Completed
First Posted : March 26, 2009
Last Update Posted : February 24, 2012
Information provided by (Responsible Party):
Luc Tappy, MD, University of Lausanne

Brief 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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Obesity Dietary Supplement: ProWHEY 94 CFM, SponserR Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of a Whey Protein Supplementation on Intrahepatic Lipids in Obese Patients With Non-alcoholic Fatty Liver Disease
Study Start Date : April 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : April 2010

Arm Intervention/treatment
Experimental: 1 Dietary Supplement: ProWHEY 94 CFM, SponserR
3 times 20g per day

Primary Outcome Measures :
  1. intrahepatic fat [ Time Frame: before and after 4 weeks of whey protein supplementation ]

Secondary Outcome Measures :
  1. glucose metabolism [ Time Frame: 4-hour oral glucose tolerance test with indirect calorimetry ]
  2. body weight and body fat [ Time Frame: before and after 4 weeks whey protein supplementation ]

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00870077

Centre d'investigations cliniques "cardiomet"/ CHUV
Lausanne, VD, Switzerland, CH-1011
Sponsors and Collaborators
University of Lausanne
Principal Investigator: Luc Tappy, MD Centre Hospitalier Universitaire Vaudois

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Luc Tappy, MD, professor of physiology, University of Lausanne Identifier: NCT00870077     History of Changes
Other Study ID Numbers: Protobese
First Posted: March 26, 2009    Key Record Dates
Last Update Posted: February 24, 2012
Last Verified: February 2012

Keywords provided by Luc Tappy, MD, University of Lausanne:
Intrahepatic fat
body fat
impaired glucose tolerance

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases