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Dietary Protein and Hepatic Fat Accumulation (LiF-Pro)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01354626
First Posted: May 17, 2011
Last Update Posted: March 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wageningen University
  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 (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 ]

Secondary Outcome Measures:
  • Biomarkers of liver function/hepatic steatosis [ Time Frame: baseline, 2 weeks, 4 weeks ]
    Biomarkers of liver function/hepatic steatosis: ALT, AST, C-reactive protein

  • Circulating cytokines [ Time Frame: baseline, 2 weeks, 4 weeks ]
    adiponectin, TNF-α

  • Postprandial lipid metabolism [ Time Frame: 2 weeks, 4 weeks ]
    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 ]
    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 ]
  • Peripheral blood mononuclear cells gene expression (PBMC's). [ Time Frame: baseline, 2 weeks, 4 weeks ]

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

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354626


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT01354626     History of Changes
Other Study ID Numbers: LiF-Pro
First Submitted: May 13, 2011
First Posted: May 17, 2011
Last Update Posted: March 15, 2012
Last Verified: March 2012

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

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases