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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00870077
First Posted: March 26, 2009
Last Update Posted: February 24, 2012
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.
Information provided by (Responsible Party):
Luc Tappy, MD, University of Lausanne
  Purpose
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.
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00870077


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luc Tappy, MD, professor of physiology, University of Lausanne
ClinicalTrials.gov Identifier: NCT00870077     History of Changes
Other Study ID Numbers: Protobese
First Submitted: March 25, 2009
First Posted: March 26, 2009
Last Update Posted: February 24, 2012
Last Verified: February 2012

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

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