Dietary Protein and Hepatic Fat Accumulation (LiF-Pro)

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. Identifier: NCT01354626
Recruitment Status : Completed
First Posted : May 17, 2011
Last Update Posted : March 15, 2012
Information provided by (Responsible Party):
Wageningen University

May 13, 2011
May 17, 2011
March 15, 2012
August 2011
March 2012   (Final data collection date for primary outcome measure)
hepatic fat accumulation [ Time Frame: baseline, 2 weeks, 4 weeks ]
Same as current
Complete list of historical versions of study NCT01354626 on Archive Site
  • Biomarkers of liver function/hepatic steatosis [ Time Frame: baseline, 2 weeks, 4 weeks ]
    Biomarkers of liver function/hepatic steatosis: ALT, AST, C-reactive protein
  • Circulating cytokines [ Time Frame: baseline, 2 weeks, 4 weeks ]
    adiponectin, TNF-α
  • Postprandial lipid metabolism [ Time Frame: 2 weeks, 4 weeks ]
    Postprandial lipid metabolism will be assessed by means of a meal challenge with the use of stable isotope tracer
  • Glucose homeostasis [ Time Frame: baseline, 2 weeks, 4 weeks ]
    Glucose homeostasis will be assessed with the homeostatic model assessment (HOMA) index in fasting blood samples. In addition dynamic indexes will be determined from the meal challenge.
  • Adipose tissue gene expression [ Time Frame: 2 weeks, 4 weeks ]
  • Peripheral blood mononuclear cells gene expression (PBMC's). [ Time Frame: baseline, 2 weeks, 4 weeks ]
Same as current
Not Provided
Not Provided
Dietary Protein and Hepatic Fat Accumulation
Influence of Increasing Dietary Protein on Hepatic Fat Accumulation and Postprandial Metabolism

The objective of this study is to investigate the potential beneficial effect of increasing protein in the diet in order to decrease hepatic lipid accumulation on a high-fat diet.

The investigators hypothesize that increasing protein in a high-fat diet suppresses lipid accumulation in the liver, and that changes in (hepatic) fat handling underlie this reduced lipid accumulation.

Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
  • Hepatic Fat Accumulation
  • Nonalcoholic Fatty Liver Disease
  • Other: dietary protein
    in the low-protein group 13EN% of protein will be provided in the diet; in the high-protein 25EN% of protein will be provided
    Other Name: diet
  • Other: low-protein
    The control group will get a diet which is according to healthy eating guidelines.
    Other Name: diet
  • Experimental: High fat diets
    High-fat-Low-protein or High-fat-high-protein
    Intervention: Other: dietary protein
  • Control group
    Low-protein-low-fat (according to healthy eating guidelines)
    Intervention: Other: low-protein
Rietman A, Schwarz J, Blokker BA, Siebelink E, Kok FJ, Afman LA, Tomé D, Mensink M. Increasing protein intake modulates lipid metabolism in healthy young men and women consuming a high-fat hypercaloric diet. J Nutr. 2014 Aug;144(8):1174-80. doi: 10.3945/jn.114.191072. Epub 2014 Jun 4.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2012
March 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy
  • body mass index (BMI) 18-25 kg/ m2;
  • stable dietary habits;
  • physical activity levels.
  • caucasian

Exclusion Criteria:

  • Unable or unwilling to comply with study procedures;
  • not caucasian
  • Unstable body weight (weight gain or loss > 3 kg in the past three months);
  • Moderate intense physical activity (exercise) for more than 4 hours/week;
  • (Chronic) disease which might influence the study outcomes e.g. diabetes mellitus or any other endocrine disorder, active cardiovascular disease, hepatic disease, renal disease, cancer;
  • Family history of diabetes mellitus;
  • Use of medication, except incidental use of paracetamol;
  • Abuse of drugs;
  • Alcohol consumption of more than 14 glasses per week;
  • Participation in another biomedical study within 1 months prior to the first screening visit;
  • Contraindications to MRI scanning. These contraindications include patients with one of the following conditions:
  • Claustrophobia;
  • Central nervous system aneurysm clips;
  • Implanted neural stimulator;
  • Implanted cardiac pacemaker or defibrillator;
  • Cochlear implant;
  • Ocular foreign body (e.g. metal shavings);
  • Insulin pump;
  • Metal shrapnel or bullet;
  • Or metal containing corpora aliena in the eye of brains.
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Wageningen University
Wageningen University
Not Provided
Not Provided
Wageningen University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP