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

February 23, 2012 updated by: Luc Tappy, MD, University of Lausanne

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • VD
      • Lausanne, VD, Switzerland, CH-1011
        • Centre d'investigations cliniques "cardiomet"/ CHUV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Dietary supplement: ProWHEY 94 CFM, SponserR
3 times 20g per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
intrahepatic fat
Time Frame: before and after 4 weeks of whey protein supplementation
before and after 4 weeks of whey protein supplementation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne

Investigators

  • Principal Investigator: Luc Tappy, MD, Centre Hospitalier Universitaire Vaudois

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

March 25, 2009

First Submitted That Met QC Criteria

March 25, 2009

First Posted (Estimate)

March 26, 2009

Study Record Updates

Last Update Posted (Estimate)

February 24, 2012

Last Update Submitted That Met QC Criteria

February 23, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protobese

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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