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

Primary Purpose

Systemic Inflammatory Response Syndrome

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Endotoxin, US standard reference E.coli
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Systemic Inflammatory Response Syndrome focused on measuring sepsis, cytokine release, fever

Eligibility Criteria

20 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Medical Research Laboratory, Department of Internal Medicine and Endocrinology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo (isotonic saline)

Acipimox + Placebo (isotonic saline)

Acipimox + free fatty acids

Acipimox + 3-hydroxybutyrate

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Protein metabolism
Measurements of protein oxidation during intervention using radioactive tracer techniques.

Secondary Outcome Measures

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

Full Information

First Posted
December 14, 2012
Last Updated
November 24, 2014
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT01752348
Brief Title
Effects of Free Fatty Acids and 3-hydroxybutyrate on Protein, Glucose, Lipid Metabolism and Intracellular Signals.
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Inflammatory Response Syndrome
Keywords
sepsis, cytokine release, fever

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo (isotonic saline)
Arm Type
Placebo Comparator
Arm Description
Endotoxin + isotonic saline. Reference for model of acute inflammatory illness
Arm Title
Acipimox + Placebo (isotonic saline)
Arm Type
Experimental
Arm Description
Endotoxin + Acipimox + Placebo (isotonic saline). Intervention: blockage of endogenous lipolysis.
Arm Title
Acipimox + free fatty acids
Arm Type
Experimental
Arm Description
Endotoxin + Acipimox + free fatty acids. Intervention: free fatty acids
Arm Title
Acipimox + 3-hydroxybutyrate
Arm Type
Experimental
Arm Description
Endotoxin + Acipimox + 3-hydroxybutyrate. Intervention: 3-hydroxybutyrate
Intervention Type
Other
Intervention Name(s)
Endotoxin, US standard reference E.coli
Primary Outcome Measure Information:
Title
Protein metabolism
Description
Measurements of protein oxidation during intervention using radioactive tracer techniques.
Time Frame
6 hours intervention period
Secondary Outcome Measure Information:
Title
Activated intracellular signalling pathways
Description
Measurements on biopsies from muscle and fatty tissue taken on day of study
Time Frame
study day
Other Pre-specified Outcome Measures:
Title
Other systemic metabolic effects
Time Frame
6 hours of intervention

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Møller, Professor
Organizational Affiliation
Institute of Clinical Medicine, Aarhus University, Denmark. Department of Internal Medicin and Endocrinology, Aarhus university hospital, Aarhus, Denmark.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Research Laboratory, Department of Internal Medicine and Endocrinology
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
30239561
Citation
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.
Results Reference
derived

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

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