Dietary Protein and Hepatic Fat Accumulation (LiF-Pro)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wageningen University
ClinicalTrials.gov Identifier:
NCT01354626
First received: May 13, 2011
Last updated: March 14, 2012
Last verified: March 2012

May 13, 2011
March 14, 2012
August 2011
March 2012   (final data collection date for primary outcome measure)
hepatic fat accumulation [ Time Frame: baseline, 2 weeks, 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01354626 on ClinicalTrials.gov Archive Site
  • Biomarkers of liver function/hepatic steatosis [ Time Frame: baseline, 2 weeks, 4 weeks ] [ Designated as safety issue: No ]
    Biomarkers of liver function/hepatic steatosis: ALT, AST, C-reactive protein
  • Circulating cytokines [ Time Frame: baseline, 2 weeks, 4 weeks ] [ Designated as safety issue: No ]
    adiponectin, TNF-α
  • Postprandial lipid metabolism [ Time Frame: 2 weeks, 4 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Peripheral blood mononuclear cells gene expression (PBMC's). [ Time Frame: baseline, 2 weeks, 4 weeks ] [ Designated as safety issue: No ]
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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
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.
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01354626
LiF-Pro
No
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