Clinical trial NCT01354626: Dietary Protein and Hepatic Fat Accumulation
Official title: Influence of Increasing Dietary Protein on Hepatic Fat Accumulation and Postprandial Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Fat Accumulation
Nonalcoholic Fatty Liver Disease
Keywords: Hepatic fat accumulation
Dietary protein
NAFLD
Lead sponsor: Wageningen University
Sponsor class: OTHER
First posted: 2011-05-17
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: hepatic fat accumulation
timeFrame: baseline, 2 weeks, 4 weeks
Secondary outcomes:
measure: Biomarkers of liver function/hepatic steatosis
timeFrame: baseline, 2 weeks, 4 weeks
measure: Circulating cytokines
timeFrame: baseline, 2 weeks, 4 weeks
measure: Postprandial lipid metabolism
timeFrame: 2 weeks, 4 weeks
measure: Glucose homeostasis
timeFrame: baseline, 2 weeks, 4 weeks
measure: Adipose tissue gene expression
timeFrame: 2 weeks, 4 weeks
measure: Peripheral blood mononuclear cells gene expression (PBMC's).
timeFrame: baseline, 2 weeks, 4 weeks
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University, Division of Human Nutrition
state: Gelderland
Study officials:
References:
citation: Rietman A, Schwarz J, Blokker BA, Siebelink E, Kok FJ, Afman LA, Tome D, Mensink M. Increasing protein intake modulates lipid metabolism in healthy young men and women consuming a high-fat hypercaloric diet. J Nutr. 2014 Aug;144(8):1174-80. doi: 10.3945/jn.114.191072. Epub 2014 Jun 4.