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

NCT ID: NCT01752348

Last Updated: 2014-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-11-30

Brief Summary

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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

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Conditions

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Systemic Inflammatory Response Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo (isotonic saline)

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

Group Type PLACEBO_COMPARATOR

Endotoxin, US standard reference E.coli

Intervention Type OTHER

Acipimox + Placebo (isotonic saline)

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

Group Type EXPERIMENTAL

Endotoxin, US standard reference E.coli

Intervention Type OTHER

Acipimox + free fatty acids

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

Group Type EXPERIMENTAL

Endotoxin, US standard reference E.coli

Intervention Type OTHER

Acipimox + 3-hydroxybutyrate

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

Group Type EXPERIMENTAL

Endotoxin, US standard reference E.coli

Intervention Type OTHER

Interventions

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Endotoxin, US standard reference E.coli

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Niels Møller, Professor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Medical Research Laboratory, Department of Internal Medicine and Endocrinology

Aarhus C, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 30239561 (View on PubMed)

Other Identifiers

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1-10-72-530-12

Identifier Type: OTHER

Identifier Source: secondary_id

11422796

Identifier Type: -

Identifier Source: org_study_id