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Completed

NCT Number: NCT00870077

A Pilot Study on Whey Protein Supplementation in 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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Body Weight Digestive System Diseases Fatty Liver Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Liver Diseases Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre d'investigations cliniques "cardiomet"/ CHUV

Lausanne, Canton of Vaud, CH-1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ProWHEY 94 CFM, SponserR

Dietary Supplement

3 times 20g per day

Primary outcomes

  1. intrahepatic fat

    Time frame: before and after 4 weeks of whey protein supplementation

Secondary outcomes

  1. glucose metabolism

    Time frame: 4-hour oral glucose tolerance test with indirect calorimetry

  2. body weight and body fat

    Time frame: before and after 4 weeks whey protein supplementation

Sponsors and collaborators

Lead sponsor

University of Lausanne

Other

Registry information

Official study title

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

Acronym: PROTOB

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Mar 26, 2009
Registry last updated
Feb 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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