This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Dietary Protein and Hepatic Fat Accumulation (LiF-Pro)

This study has been completed.
Information provided by (Responsible Party):
Wageningen University Identifier:
First received: May 13, 2011
Last updated: March 14, 2012
Last verified: March 2012

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.

Condition Intervention
Hepatic Fat Accumulation Nonalcoholic Fatty Liver Disease Other: dietary protein Other: low-protein

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Influence of Increasing Dietary Protein on Hepatic Fat Accumulation and Postprandial Metabolism

Resource links provided by NLM:

Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • hepatic fat accumulation [ Time Frame: baseline, 2 weeks, 4 weeks ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 29
Study Start Date: August 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High fat diets
High-fat-Low-protein or High-fat-high-protein
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
Control group
Low-protein-low-fat (according to healthy eating guidelines)
Other: low-protein
The control group will get a diet which is according to healthy eating guidelines.
Other Name: diet


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
  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 identifier: NCT01354626

Wageningen University, Division of Human Nutrition
Wageningen, Gelderland, Netherlands, 6703 HD
Sponsors and Collaborators
Wageningen University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Wageningen University Identifier: NCT01354626     History of Changes
Other Study ID Numbers: LiF-Pro
Study First Received: May 13, 2011
Last Updated: March 14, 2012

Keywords provided by Wageningen University:
Hepatic fat accumulation
Dietary protein

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases processed this record on August 18, 2017