Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects

Liver Diseases Clinical Trial

Official title:

Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00931060
• Other study ID #: 15580
• Status: Completed
• Phase: N/A
• First received: June 30, 2009
• Last updated: September 14, 2009
• Start date: November 2007
• Est. completion date: June 2009

Study information

• Verified date: September 2009
• 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 this study is to determine whether Branched chain Amino Acids enhances the uptake of ammonia in muscle tissue.

Description:

Branched-chain amino acids (BCAA; leucine, valine, isoleucine) are used to prevent hepatic encephalopathy in cirrhotic patients. The main effect of BCAAs is believed to take place in muscles where BCAAs provide carbon-skeletons for the TCA-cycle. This enhances the conversion of alfa-ketoglutarate to ammonia via glutamine.

We intend to study the effect of oral administered BCAA on the metabolism of ammonia and amino acids across the leg-muscles by means of catheters inserted into the femoral artery (A) and vein (V). Muscle blood flow (F; L/min) will be determined by constant infusion of indocyanine green and indicator dilution principle. Arterial blood flow and A and V concentrations of ammonia and amino acids will be measured before an oral load of BCAA (0.45 g BCAA/kg body weight) and after 1 and 3 hours. The metabolism of ammonia will also be estimated by means of 13N-NH3 PET scans.

Hypothesis: BCAA increases the uptake of ammonia in muscle tissue and lowers arterial ammonia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18 patients with liver cirrhosis

• 6 healthy subjects age and sex matched

Exclusion Criteria:

• Non-treated diabetes

• Pregnancy/breast-feeding

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy
• Hepatic Insufficiency
• Liver Diseases

Intervention

Dietary Supplement:
• Branched chain amino acids
Branched chain amino acids 0.45g/kg BW. Oral supplement. Administered once on study day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	arterial ammonia concentration		1 and 3 hours	No
Secondary	muscle ammonia metabolism		1 hour and 3 hours	No

External Links

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