Dietary Protein and Hepatic Fat Accumulation (LiF-Pro)

Wageningen University

Status: Completed

Conditions: Nonalcoholic Fatty Liver Disease; Hepatic Fat Accumulation

Treatments: Other: dietary protein; Other: low-protein

Study type: Interventional

Funder types: Other

Identifiers

NCT01354626

LiF-Pro

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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29 participants in 2 patient groups

High fat diets

Experimental group

Description:

High-fat-Low-protein or High-fat-high-protein

Treatment:

Other: dietary protein

Control group

Other group

Description:

Low-protein-low-fat (according to healthy eating guidelines)

Treatment:

Other: low-protein