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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
History of Changes
  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:

U.S. FDA Resources

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 May 22, 2013