The Effects of Amino Acid Supplement During Acute Inflammation.

November 11, 2014 updated by: Nikolaj Fibiger Rittig, University of Aarhus

Metabolic Effects of Endotoxin Induced Acute Inflammation in Healthy Young Men With and Without Supplement of Amino Acids.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Jylland
      • Aarhus C, Jylland, Denmark, 8000
        • Medical Department MEA, NBG, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Saline
Only saline is given.
Placebo Comparator: + Saline
Endotoxin is given + Placebo (Saline)
Biological: E. coli endotoxin, US standard
Active Comparator: + amino acids
Endotoxin is given + amino acids (intravenously)
Biological: E. coli endotoxin, US standard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protein catabolism during acute illness
Time Frame: After 6 hours intervention
Protein catabolism is measured with amino acid tracer techniques comparing radioactive marked amino acids from blood samples.
After 6 hours intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The local effects on muscle and fat tissue
Time Frame: At 2 hours and 4,5 hours
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
Other systemic metabolic effects during acute illness
Time Frame: 6 hours
Lipid and glucose metabolism are measured with tracer techniques with radioactive marked glucose + lipid.
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 8, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (Estimate)

October 12, 2012

Study Record Updates

Last Update Posted (Estimate)

November 13, 2014

Last Update Submitted That Met QC Criteria

November 11, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-410-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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