Local Effects of Amino Acids and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg

NCT ID: NCT01461603

Last Updated: 2016-03-03

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2016-07-31

Brief Summary

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Introduction: Protein loss during critical illness is an important problem and is shown to predict overall survival. In animal studies, infusion of leucine is shown to increase the synthesis of muscle protein by 30-40% and decrease protein degradation by 30%.

Objectives: Compared to saline, an amino acid or 3hydroxybutyrate infusion in the femoral artery will promote protein synthesis and inhibit breakdown assessed with local a/v phenylalanine and tyrosine tracer kinetics in healthy volunteers. These effects will include distinct alterations in muscle signal events, in particular mTOR.

Methods: n = 10 healthy male subjects are equipped with catheters in aa. femorals and vv. femorals bilaterally under local anaesthetics. Each study comprises a 3-hour basal period and a 3-hour period with hyperinsulinaemic-euglycaemic clamp. During the test, samples of arterial and venous blood and 4 muscle biopsies are obtained. The intervention contain continues saline infusion compared to either amino acids (Vamin) or 3hydroxybutyrate solution FFa-3OHB.

Perspectives: This study elucidates the direct effect of aminoacids and ketone bodies on muscle protein metabolism in humans and contribute to further development of nutritional therapy in human catabolic states.

Detailed Description

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Conditions

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Critical Illness Protein Metabolism Pharmaconutrients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Amino acids

Amino acids compared to saline

Group Type ACTIVE_COMPARATOR

Vamin (Fresenius Kabi)

Intervention Type DIETARY_SUPPLEMENT

Vamin 18gN 1ml/min infusion in 6 hours

3hydroxybutyrat (3OHB)

Ketone body, 3OHB compared to saline

Group Type ACTIVE_COMPARATOR

3hydroxybutyrate

Intervention Type DIETARY_SUPPLEMENT

Goldbio, FFA-3OHB, dry powder mixed with sterile water at Aarhus University hospital pharmacy.

Interventions

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Vamin (Fresenius Kabi)

Vamin 18gN 1ml/min infusion in 6 hours

Intervention Type DIETARY_SUPPLEMENT

3hydroxybutyrate

Goldbio, FFA-3OHB, dry powder mixed with sterile water at Aarhus University hospital pharmacy.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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3OHB, 3hydroxybutyric acid

Eligibility Criteria

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Inclusion Criteria

* BMI between 19 and 28
* Written consent before study start

Exclusion Criteria

* Diabetes
* Inclusion in other studies using ionizing radiation.
* Allergic to egg or soy
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 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, Dr.Med.

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

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M-researchlab. MEA, Aarhus University Hospital, NBG

Aarhus C, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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M-20110177

Identifier Type: -

Identifier Source: org_study_id

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