NCT01354626

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 15, 2012

Status Verified

March 1, 2012

Enrollment Period

7 months

First QC Date

May 13, 2011

Last Update Submit

March 14, 2012

Conditions

Hepatic Fat AccumulationNonalcoholic Fatty Liver Disease

Keywords

Hepatic fat accumulationDietary proteinNAFLD

Outcome Measures

Primary Outcomes (1)

  • hepatic fat accumulation

    baseline, 2 weeks, 4 weeks

Secondary Outcomes (6)

  • Biomarkers of liver function/hepatic steatosis

    baseline, 2 weeks, 4 weeks

  • Circulating cytokines

    baseline, 2 weeks, 4 weeks

  • Postprandial lipid metabolism

    2 weeks, 4 weeks

  • Glucose homeostasis

    baseline, 2 weeks, 4 weeks

  • Adipose tissue gene expression

    2 weeks, 4 weeks

  • +1 more secondary outcomes

Study Arms (2)

High fat diets

EXPERIMENTAL

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

Other: dietary protein

Control group

OTHER

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

Other: low-protein

Interventions

dietary proteinOTHER

in the low-protein group 13EN% of protein will be provided in the diet; in the high-protein 25EN% of protein will be provided

Also known as: diet
High fat diets
low-proteinOTHER

The control group will get a diet which is according to healthy eating guidelines.

Also known as: diet
Control group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • body mass index (BMI) 18-25 kg/ m2;
  • stable dietary habits;
  • physical activity levels.
  • caucasian

You may not qualify if:

  • 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;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University, Division of Human Nutrition

Wageningen, Gelderland, 6703 HD, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 24899158DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Dietary ProteinsDietDiet, Protein-Restricted

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesNutritional Physiological PhenomenaDiet TherapyNutrition TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2011

First Posted

May 17, 2011

Study Start

August 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

March 15, 2012

Record last verified: 2012-03

Locations

NL(1)