Back to resultsA Pilot Study on Whey Protein Supplementation in Non Alcoholic Fatty Liver Disease (PROTOB)
Primary Purpose
Non-alcoholic Fatty Liver Disease, Obesity
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
ProWHEY 94 CFM, SponserR
Sponsored by
About this trial
This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease focused on measuring Intrahepatic fat, obesity, body fat, impaired glucose tolerance
Eligibility 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
Sites / Locations
- Centre d'investigations cliniques "cardiomet"/ CHUV
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
intrahepatic fat
Secondary Outcome Measures
glucose metabolism
body weight and body fat
Full Information
NCT ID
NCT00870077
First Posted
March 25, 2009
Last Updated
February 23, 2012
Sponsor
University of Lausanne
1. Study Identification
Unique Protocol Identification Number
NCT00870077
Brief Title
A Pilot Study on Whey Protein Supplementation in Non Alcoholic Fatty Liver Disease
Acronym
PROTOB
Official Title
Effect of a Whey Protein Supplementation on Intrahepatic Lipids in Obese Patients With Non-alcoholic Fatty Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease, Obesity
Keywords
Intrahepatic fat, obesity, body fat, impaired glucose tolerance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
ProWHEY 94 CFM, SponserR
Intervention Description
3 times 20g per day
Primary Outcome Measure Information:
Title
intrahepatic fat
Time Frame
before and after 4 weeks of whey protein supplementation
Secondary Outcome Measure Information:
Title
glucose metabolism
Time Frame
4-hour oral glucose tolerance test with indirect calorimetry
Title
body weight and body fat
Time Frame
before and after 4 weeks whey protein supplementation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc Tappy, MD
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre d'investigations cliniques "cardiomet"/ CHUV
City
Lausanne
State/Province
VD
ZIP/Postal Code
CH-1011
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21288612
Citation
Bortolotti M, Maiolo E, Corazza M, Van Dijke E, Schneiter P, Boss A, Carrel G, Giusti V, Le KA, Quo Chong DG, Buehler T, Kreis R, Boesch C, Tappy L. Effects of a whey protein supplementation on intrahepatocellular lipids in obese female patients. Clin Nutr. 2011 Aug;30(4):494-8. doi: 10.1016/j.clnu.2011.01.006. Epub 2011 Feb 1.
Results Reference
derived
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A Pilot Study on Whey Protein Supplementation in Non Alcoholic Fatty Liver Disease
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