Dietary Protein and Hepatic Fat Accumulation (LiF-Pro)
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.
|Hepatic Fat Accumulation Nonalcoholic Fatty Liver Disease||Other: dietary protein Other: low-protein|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
|Official Title:||Influence of Increasing Dietary Protein on Hepatic Fat Accumulation and Postprandial Metabolism|
- hepatic fat accumulation [ Time Frame: baseline, 2 weeks, 4 weeks ]
- 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 ]
|Study Start Date:||August 2011|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
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
Low-protein-low-fat (according to healthy eating guidelines)
The control group will get a diet which is according to healthy eating guidelines.
Other Name: diet
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354626
|Wageningen University, Division of Human Nutrition|
|Wageningen, Gelderland, Netherlands, 6703 HD|