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Completed

NCT Number: NCT01752348

Effects of Free Fatty Acids and 3-hydroxybutyrate on Protein, Glucose, Lipid Metabolism and Intracellular Signals.

The investigators hypothesize that the investigators can detect protein-sparing effects of administration of the ketone 3-hydroxybutyrate and free fatty acids during simulation of an acute inflammatory disease. The investigators use the infusion of endotoxin, US standard reference E.coli in healthy subjects as a model for inflammation / infection and to evaluate the effect on protein metabolism using different tracers and the investigators can measure the various intracellular signaling pathways of selected muscle and adipose tissue.

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Key information

Conditions

Systemic Inflammatory Response Syndrome Body Temperature Changes Fever Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Medical Research Laboratory, Department of Internal Medicine and Endocrinology

Aarhus C, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 20 < body mass index < 30 kg/m2.
  • written and orally informed consent before enrollment.

Exclusion criteria

  • participation in other studies using radioactive tracers or other exposure to radiation (X-rays, scintigraphy etc).
  • allergy to soy products or eggs
  • diabetes, any type
  • epilepsy
  • ongoing infection
  • immune deficiency
  • cardiovascular disease
  • dysregulated hypertension
  • primary muscles disease, congenital or acquired

Treatment and study plan

Endotoxin, US standard reference E.coli

Other

Primary outcomes

  1. Protein metabolism

    Time frame: 6 hours intervention period

    Measurements of protein oxidation during intervention using radioactive tracer techniques.

Secondary outcomes

  1. Activated intracellular signalling pathways

    Time frame: study day

    Measurements on biopsies from muscle and fatty tissue taken on day of study

Other outcomes

  1. Other systemic metabolic effects

    Time frame: 6 hours of intervention

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Effects of Free Fatty Acids and 3-hydroxybutyrate on Protein, Glucose, Lipid Metabolism and Intracellular Signals; a Study on Muscle Wasting and Metabolism During Acute Inflammation and Potential Anabolic Mechanisms.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 19, 2012
Registry last updated
Nov 25, 2014

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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