NCT01752348

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

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

December 14, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 25, 2014

Status Verified

July 1, 2013

Enrollment Period

1.4 years

First QC Date

December 14, 2012

Last Update Submit

November 24, 2014

Conditions

Systemic Inflammatory Response Syndrome

Keywords

sepsiscytokine releasefever

Outcome Measures

Primary Outcomes (1)

  • Protein metabolism

    Measurements of protein oxidation during intervention using radioactive tracer techniques.

    6 hours intervention period

Secondary Outcomes (1)

  • Activated intracellular signalling pathways

    study day

Other Outcomes (1)

  • Other systemic metabolic effects

    6 hours of intervention

Study Arms (4)

Placebo (isotonic saline)

PLACEBO COMPARATOR

Endotoxin + isotonic saline. Reference for model of acute inflammatory illness

Other: Endotoxin, US standard reference E.coli

Acipimox + Placebo (isotonic saline)

EXPERIMENTAL

Endotoxin + Acipimox + Placebo (isotonic saline). Intervention: blockage of endogenous lipolysis.

Other: Endotoxin, US standard reference E.coli

Acipimox + free fatty acids

EXPERIMENTAL

Endotoxin + Acipimox + free fatty acids. Intervention: free fatty acids

Other: Endotoxin, US standard reference E.coli

Acipimox + 3-hydroxybutyrate

EXPERIMENTAL

Endotoxin + Acipimox + 3-hydroxybutyrate. Intervention: 3-hydroxybutyrate

Other: Endotoxin, US standard reference E.coli

Interventions

Endotoxin, US standard reference E.coliOTHER
Acipimox + 3-hydroxybutyrateAcipimox + Placebo (isotonic saline)Acipimox + free fatty acidsPlacebo (isotonic saline)

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Research Laboratory, Department of Internal Medicine and Endocrinology

Aarhus C, 8000, Denmark

Location

Related Publications (1)

  • Thomsen HH, Rittig N, Johannsen M, Moller AB, Jorgensen JO, Jessen N, Moller N. Effects of 3-hydroxybutyrate and free fatty acids on muscle protein kinetics and signaling during LPS-induced inflammation in humans: anticatabolic impact of ketone bodies. Am J Clin Nutr. 2018 Oct 1;108(4):857-867. doi: 10.1093/ajcn/nqy170.

    PMID: 30239561DERIVED

MeSH Terms

Conditions

Systemic Inflammatory Response SyndromeSepsisFever

Interventions

Endotoxins

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockInfectionsBody Temperature ChangesSigns and Symptoms

Intervention Hierarchy (Ancestors)

Bacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Niels Møller, Professor

    Institute of Clinical Medicine, Aarhus University, Denmark. Department of Internal Medicin and Endocrinology, Aarhus university hospital, Aarhus, Denmark.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2012

First Posted

December 19, 2012

Study Start

February 1, 2013

Primary Completion

July 1, 2014

Study Completion

November 1, 2014

Last Updated

November 25, 2014

Record last verified: 2013-07

Locations

DK(1)