NCT00931060

Brief Summary

The purpose of this study is to determine whether Branched chain Amino Acids enhances the uptake of ammonia in muscle tissue.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2009

Completed
Last Updated

September 15, 2009

Status Verified

September 1, 2009

Enrollment Period

1.6 years

First QC Date

June 30, 2009

Last Update Submit

September 14, 2009

Conditions

Liver DiseasesHepatic EncephalopathyHepatic Insufficiency

Keywords

AmmoniaCitric acid cycleBranched Chain Amino Acids

Outcome Measures

Primary Outcomes (1)

  • arterial ammonia concentration

    1 and 3 hours

Secondary Outcomes (1)

  • muscle ammonia metabolism

    1 hour and 3 hours

Study Arms (1)

Branched chain amino acids

EXPERIMENTAL

Patients with cirrhosis. Healthy subjects age and sex matched

Dietary Supplement: Branched chain amino acids

Interventions

Branched chain amino acidsDIETARY_SUPPLEMENT

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

Branched chain amino acids

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with liver cirrhosis
  • healthy subjects age and sex matched

You may not qualify if:

  • Non-treated diabetes
  • Pregnancy/breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver DiseasesHepatic EncephalopathyHepatic Insufficiency

Interventions

Amino Acids

Condition Hierarchy (Ancestors)

Digestive System DiseasesLiver FailureBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

  • Susanne Keiding, MD

    PET Centre and Medical department V, Aarhus Sygehus, Aarhus University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2009

First Posted

July 2, 2009

Study Start

November 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

September 15, 2009

Record last verified: 2009-09