Dietary Protein and Hepatic Fat Accumulation

Nonalcoholic Fatty Liver Disease Clinical Trial

— LiF-Pro  

Official title:

Influence of Increasing Dietary Protein on Hepatic Fat Accumulation and Postprandial Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01354626
• Other study ID #: LiF-Pro
• Status: Completed
• Phase: N/A
• First received: May 13, 2011
• Last updated: March 14, 2012
• Start date: August 2011
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fatty Liver
• Hepatic Fat Accumulation
• Liver Diseases
• Nonalcoholic Fatty Liver Disease

Intervention

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
• low-protein
The control group will get a diet which is according to healthy eating guidelines.

Locations

Country	Name	City	State
Netherlands	Wageningen University, Division of Human Nutrition	Wageningen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hepatic fat accumulation		baseline, 2 weeks, 4 weeks	No
Secondary	Biomarkers of liver function/hepatic steatosis	Biomarkers of liver function/hepatic steatosis: ALT, AST, C-reactive protein	baseline, 2 weeks, 4 weeks	No
Secondary	Circulating cytokines	adiponectin, TNF-a	baseline, 2 weeks, 4 weeks	No
Secondary	Postprandial lipid metabolism	Postprandial lipid metabolism will be assessed by means of a meal challenge with the use of stable isotope tracer	2 weeks, 4 weeks	No
Secondary	Glucose homeostasis	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.	baseline, 2 weeks, 4 weeks	No
Secondary	Adipose tissue gene expression		2 weeks, 4 weeks	No
Secondary	Peripheral blood mononuclear cells gene expression (PBMC's).		baseline, 2 weeks, 4 weeks	No