Hepatic Fat Accumulation, Nonalcoholic Fatty Liver Disease
Conditions
Keywords
Hepatic fat accumulation, Dietary protein, NAFLD
Brief summary
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.
Interventions
OTHERdietary 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
OTHERlow-protein
The control group will get a diet which is according to healthy eating guidelines.
Sponsors
Wageningen University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hepatic fat accumulation | baseline, 2 weeks, 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adipose tissue gene expression | 2 weeks, 4 weeks | — |
| Biomarkers of liver function/hepatic steatosis | baseline, 2 weeks, 4 weeks | Biomarkers of liver function/hepatic steatosis: ALT, AST, C-reactive protein |
| Peripheral blood mononuclear cells gene expression (PBMC's). | baseline, 2 weeks, 4 weeks | — |
| Postprandial lipid metabolism | 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 | 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. |
| Circulating cytokines | baseline, 2 weeks, 4 weeks | adiponectin, TNF-α |
Countries
Netherlands
Outcome results
None listed