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

Not Applicable

Completed

• Conditions: Systemic Inflammatory Response Syndrome
• Interventions: Other: Endotoxin, US standard reference E.coli

• Registration Number: NCT01752348
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-12-14
• Study First Submitted QC: 2012-12-18
• Study First Posted: 2012-12-19
• Study Start: 2013-02
• Status Verified: 2013-07
• Primary Completion: 2014-07
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-24
• Last Update Posted: 2014-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acipimox + free fatty acids	Endotoxin, US standard reference E.coli	Endotoxin + Acipimox + free fatty acids. Intervention: free fatty acids
Acipimox + Placebo (isotonic saline)	Endotoxin, US standard reference E.coli	Endotoxin + Acipimox + Placebo (isotonic saline). Intervention: blockage of endogenous lipolysis.
Placebo (isotonic saline)	Endotoxin, US standard reference E.coli	Endotoxin + isotonic saline. Reference for model of acute inflammatory illness
Acipimox + 3-hydroxybutyrate	Endotoxin, US standard reference E.coli	Endotoxin + Acipimox + 3-hydroxybutyrate. Intervention: 3-hydroxybutyrate

Primary Outcome Measures

Name	Time	Method
Protein metabolism	6 hours intervention period	Measurements of protein oxidation during intervention using radioactive tracer techniques.

Secondary Outcome Measures

Name	Time	Method
Activated intracellular signalling pathways	study day	Measurements on biopsies from muscle and fatty tissue taken on day of study

Trial Locations

Locations (1)

Medical Research Laboratory, Department of Internal Medicine and Endocrinology; 🇩🇰 Aarhus C, Denmark