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Completed

NCT Number: NCT01354626

Dietary Protein and Hepatic Fat Accumulation

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.

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Key information

Conditions

Hepatic Fat Accumulation Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease Nonalcoholic Fatty Liver Disease

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University, Division of Human Nutrition

Wageningen, Gelderland, 6703 HD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary Protein

Other

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 names: diet

low-protein

Other

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

Other names: diet

Primary outcomes

  1. hepatic fat accumulation

    Time frame: baseline, 2 weeks, 4 weeks

Secondary outcomes

  1. Biomarkers of liver function/hepatic steatosis

    Time frame: baseline, 2 weeks, 4 weeks

    Biomarkers of liver function/hepatic steatosis: ALT, AST, C-reactive protein

  2. Circulating cytokines

    Time frame: baseline, 2 weeks, 4 weeks

    adiponectin, TNF-α

  3. 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

  4. 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.

  5. Adipose tissue gene expression

    Time frame: 2 weeks, 4 weeks

  6. Peripheral blood mononuclear cells gene expression (PBMC's).

    Time frame: baseline, 2 weeks, 4 weeks

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Registry information

Official study title

Influence of Increasing Dietary Protein on Hepatic Fat Accumulation and Postprandial Metabolism

Acronym: LiF-Pro

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 17, 2011
Registry last updated
Mar 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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