Dietary Protein and Hepatic Fat Accumulation

Not Applicable

Completed

• Conditions: Hepatic Fat Accumulation; Nonalcoholic Fatty Liver Disease
• Interventions: Other: low-protein; Other: dietary protein

• Registration Number: NCT01354626
• Lead Sponsor: Wageningen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-13
• Study First Submitted QC: 2011-05-16
• Study First Posted: 2011-05-17
• Study Start: 2011-08
• Status Verified: 2012-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-03-14
• Last Update Posted: 2012-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control group	low-protein	Low-protein-low-fat (according to healthy eating guidelines)
High fat diets	dietary protein	High-fat-Low-protein or High-fat-high-protein

Primary Outcome Measures

Name	Time	Method
hepatic fat accumulation	baseline, 2 weeks, 4 weeks

Secondary Outcome Measures

Name	Time	Method
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
Peripheral blood mononuclear cells gene expression (PBMC's).	baseline, 2 weeks, 4 weeks
Circulating cytokines	baseline, 2 weeks, 4 weeks	adiponectin, TNF-α
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.
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

Trial Locations

Locations (1)

Wageningen University, Division of Human Nutrition; 🇳🇱 Wageningen, Gelderland, Netherlands