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

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Participant)
  • Study Primary Completion Date: July 2014

Interventions

  • Other: Endotoxin, US standard reference E.coli

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo (isotonic saline)
    • Endotoxin + isotonic saline. Reference for model of acute inflammatory illness
  • Experimental: Acipimox + Placebo (isotonic saline)
    • Endotoxin + Acipimox + Placebo (isotonic saline). Intervention: blockage of endogenous lipolysis.
  • Experimental: Acipimox + free fatty acids
    • Endotoxin + Acipimox + free fatty acids. Intervention: free fatty acids
  • Experimental: Acipimox + 3-hydroxybutyrate
    • Endotoxin + Acipimox + 3-hydroxybutyrate. Intervention: 3-hydroxybutyrate

Clinical Trial Outcome Measures

Primary Measures

  • Protein metabolism
    • Time Frame: 6 hours intervention period
    • Measurements of protein oxidation during intervention using radioactive tracer techniques.

Secondary Measures

  • Activated intracellular signalling pathways
    • Time Frame: study day
    • Measurements on biopsies from muscle and fatty tissue taken on day of study

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 20 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Aarhus
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Niels Møller, Professor, Principal Investigator, Institute of Clinical Medicine, Aarhus University, Denmark. Department of Internal Medicin and Endocrinology, Aarhus university hospital, Aarhus, Denmark.

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