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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luc Tappy, MD, University of Lausanne
ClinicalTrials.gov Identifier:
NCT00870077
First received: March 25, 2009
Last updated: February 23, 2012
Last verified: February 2012
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 University of Lausanne:

Primary Outcome Measures:
  • intrahepatic fat [ Time Frame: before and after 4 weeks of whey protein supplementation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • glucose metabolism [ Time Frame: 4-hour oral glucose tolerance test with indirect calorimetry ] [ Designated as safety issue: No ]
  • body weight and body fat [ Time Frame: before and after 4 weeks whey protein supplementation ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Lausanne

Additional 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
Study First Received: March 25, 2009
Last Updated: February 23, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Lausanne:
Intrahepatic fat
obesity
body fat
impaired glucose tolerance

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Obesity
Digestive System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014