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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01705782
Other study ID # 2012-410-12
Secondary ID
Status Completed
Phase N/A
First received October 8, 2012
Last updated November 11, 2014
Start date October 2012
Est. completion date December 2013

Study information

Verified date November 2014
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of the study is to investigate the metabolic effects during acute inflammation with and without the nutritional supplement of amino acids.

E. Coli Endotoxin (LPS, lipopolysaccharide) is used to initiate an inflammatory response.

The study is an interventional randomized placebo study including 8 healthy male subjects. Each subject participates 3 times (different days) and are given one of following interventions:

- Placebo (NaCl)

- Endotoxin, US standard reference E.Coli + Placebo (NaCl)

- Endotoxin, US standard reference E.Coli + Amino acids (intravenously)

It is our hypothesis that the nutritional intervention during acute inflammation plays an important role in lipid and protein metabolism.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 25 Years and older
Eligibility Inclusion Criteria:

- male gender

- 20<BMI<30

- Age > 25 years old

- Written consent before starting the study

Exclusion Criteria:

- Allergy for soya products ore egg

- Diabetes

- Epilepsy

- Infection

- Immune defects

- Heart disease

- Dysregulated hypertension

- Participating in other trials using radioactive tracers or x-rays the last year.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
E. coli endotoxin, US standard


Locations

Country Name City State
Denmark Medical Department MEA, NBG, Aarhus University Hospital Aarhus C Jylland

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Protein catabolism during acute illness Protein catabolism is measured with amino acid tracer techniques comparing radioactive marked amino acids from blood samples. After 6 hours intervention No
Secondary The local effects on muscle and fat tissue A muscle + fat biopsy are taken twice during the intervention to focus on the local effects in these tissues. At 2 hours and 4,5 hours No
Secondary Other systemic metabolic effects during acute illness Lipid and glucose metabolism are measured with tracer techniques with radioactive marked glucose + lipid. 6 hours No
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