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

This study has been completed.
Information provided by (Responsible Party):
Luc Tappy, MD, University of Lausanne Identifier:
First received: March 25, 2009
Last updated: February 23, 2012
Last verified: February 2012
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 Intervention
Non-alcoholic Fatty Liver Disease Obesity Dietary Supplement: ProWHEY 94 CFM, SponserR

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Luc Tappy, MD, University of Lausanne:

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

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

Enrollment: 11
Study Start Date: April 2009
Study Completion Date: April 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Dietary Supplement: ProWHEY 94 CFM, SponserR
3 times 20g per day

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.

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
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Please refer to this study by its identifier: 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
  More Information

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
Study First Received: March 25, 2009
Last Updated: February 23, 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 processed this record on September 21, 2017