Dietary Protein and Hepatic Fat Accumulation (LiF-Pro)
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|ClinicalTrials.gov Identifier: NCT01354626|
Recruitment Status : Completed
First Posted : May 17, 2011
Last Update Posted : March 15, 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 or disease||Intervention/treatment||Phase|
|Hepatic Fat Accumulation Nonalcoholic Fatty Liver Disease||Other: dietary protein Other: low-protein||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Influence of Increasing Dietary Protein on Hepatic Fat Accumulation and Postprandial Metabolism|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354626
|Wageningen University, Division of Human Nutrition|
|Wageningen, Gelderland, Netherlands, 6703 HD|