search
Back to results

Dietary Protein and Hepatic Fat Accumulation (LiF-Pro)

Primary Purpose

Hepatic Fat Accumulation, Nonalcoholic Fatty Liver Disease

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
dietary protein
low-protein
Sponsored by
Wageningen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatic Fat Accumulation focused on measuring Hepatic fat accumulation, Dietary protein, NAFLD

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Wageningen University, Division of Human Nutrition

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

High fat diets

Control group

Arm Description

High-fat-Low-protein or High-fat-high-protein

Low-protein-low-fat (according to healthy eating guidelines)

Outcomes

Primary Outcome Measures

hepatic fat accumulation

Secondary Outcome Measures

Biomarkers of liver function/hepatic steatosis
Biomarkers of liver function/hepatic steatosis: ALT, AST, C-reactive protein
Circulating cytokines
adiponectin, TNF-α
Postprandial lipid metabolism
Postprandial lipid metabolism will be assessed by means of a meal challenge with the use of stable isotope tracer
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.
Adipose tissue gene expression
Peripheral blood mononuclear cells gene expression (PBMC's).

Full Information

First Posted
May 13, 2011
Last Updated
March 14, 2012
Sponsor
Wageningen University
search

1. Study Identification

Unique Protocol Identification Number
NCT01354626
Brief Title
Dietary Protein and Hepatic Fat Accumulation
Acronym
LiF-Pro
Official Title
Influence of Increasing Dietary Protein on Hepatic Fat Accumulation and Postprandial Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wageningen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Fat Accumulation, Nonalcoholic Fatty Liver Disease
Keywords
Hepatic fat accumulation, Dietary protein, NAFLD

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High fat diets
Arm Type
Experimental
Arm Description
High-fat-Low-protein or High-fat-high-protein
Arm Title
Control group
Arm Type
Other
Arm Description
Low-protein-low-fat (according to healthy eating guidelines)
Intervention Type
Other
Intervention Name(s)
dietary protein
Other Intervention Name(s)
diet
Intervention Description
in the low-protein group 13EN% of protein will be provided in the diet; in the high-protein 25EN% of protein will be provided
Intervention Type
Other
Intervention Name(s)
low-protein
Other Intervention Name(s)
diet
Intervention Description
The control group will get a diet which is according to healthy eating guidelines.
Primary Outcome Measure Information:
Title
hepatic fat accumulation
Time Frame
baseline, 2 weeks, 4 weeks
Secondary Outcome Measure Information:
Title
Biomarkers of liver function/hepatic steatosis
Description
Biomarkers of liver function/hepatic steatosis: ALT, AST, C-reactive protein
Time Frame
baseline, 2 weeks, 4 weeks
Title
Circulating cytokines
Description
adiponectin, TNF-α
Time Frame
baseline, 2 weeks, 4 weeks
Title
Postprandial lipid metabolism
Description
Postprandial lipid metabolism will be assessed by means of a meal challenge with the use of stable isotope tracer
Time Frame
2 weeks, 4 weeks
Title
Glucose homeostasis
Description
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.
Time Frame
baseline, 2 weeks, 4 weeks
Title
Adipose tissue gene expression
Time Frame
2 weeks, 4 weeks
Title
Peripheral blood mononuclear cells gene expression (PBMC's).
Time Frame
baseline, 2 weeks, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Wageningen University, Division of Human Nutrition
City
Wageningen
State/Province
Gelderland
ZIP/Postal Code
6703 HD
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
24899158
Citation
Rietman A, Schwarz J, Blokker BA, Siebelink E, Kok FJ, Afman LA, Tome D, Mensink M. Increasing protein intake modulates lipid metabolism in healthy young men and women consuming a high-fat hypercaloric diet. J Nutr. 2014 Aug;144(8):1174-80. doi: 10.3945/jn.114.191072. Epub 2014 Jun 4.
Results Reference
derived

Learn more about this trial

Dietary Protein and Hepatic Fat Accumulation

We'll reach out to this number within 24 hrs