Dietary Protein and Hepatic Fat Accumulation (LiF-Pro)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wageningen University
ClinicalTrials.gov Identifier:
NCT01354626
First received: May 13, 2011
Last updated: March 14, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Hepatic Fat Accumulation
Nonalcoholic Fatty Liver Disease
Other: dietary protein
Other: low-protein

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Influence of Increasing Dietary Protein on Hepatic Fat Accumulation and Postprandial Metabolism

Resource links provided by NLM:


Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • hepatic fat accumulation [ Time Frame: baseline, 2 weeks, 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biomarkers of liver function/hepatic steatosis [ Time Frame: baseline, 2 weeks, 4 weeks ] [ Designated as safety issue: No ]
    Biomarkers of liver function/hepatic steatosis: ALT, AST, C-reactive protein

  • Circulating cytokines [ Time Frame: baseline, 2 weeks, 4 weeks ] [ Designated as safety issue: No ]
    adiponectin, TNF-α

  • Postprandial lipid metabolism [ Time Frame: 2 weeks, 4 weeks ] [ Designated as safety issue: No ]
    Postprandial lipid metabolism will be assessed by means of a meal challenge with the use of stable isotope tracer

  • Glucose homeostasis [ Time Frame: baseline, 2 weeks, 4 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks, 4 weeks ] [ Designated as safety issue: No ]
  • Peripheral blood mononuclear cells gene expression (PBMC's). [ Time Frame: baseline, 2 weeks, 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: August 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High fat diets
High-fat-Low-protein or High-fat-high-protein
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
Other Name: diet
Control group
Low-protein-low-fat (according to healthy eating guidelines)
Other: low-protein
The control group will get a diet which is according to healthy eating guidelines.
Other Name: diet

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354626

Locations
Netherlands
Wageningen University, Division of Human Nutrition
Wageningen, Gelderland, Netherlands, 6703 HD
Sponsors and Collaborators
Wageningen University
  More Information

No publications provided

Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT01354626     History of Changes
Other Study ID Numbers: LiF-Pro
Study First Received: May 13, 2011
Last Updated: March 14, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Wageningen University:
Hepatic fat accumulation
Dietary protein
NAFLD

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 20, 2014