NCT00228644

Brief Summary

Availability of sulfur amino acids (SAA) is critical for glutathione/glutathione disulfide (GSH/GSSG) and cysteine/cystine (CYS/CYSS) redox in vivo and for many other physiologic functions including protein synthesis, nitrogen balance, digestion, osmotic regulation, detoxification, hormonal regulation, biologic methylations, and cell growth regulation. GSH conjugation and sulfate conjugation represent quantitatively important pathways for chemical detoxification, which imposes substantial burden upon SAA supply. The primary hypothesis is that SAA deficient diet and acetaminophen (APAP) administration will perturb Cys metabolism and GSH redox homeostasis in human plasma and urinary output of SAA metabolites. Because both of these variations affect SAA homeostasis, it is believed that the combination of these treatments will produce an interactive effect in which 2-day SAA deficiency will alter APAP metabolism, APAP will affect SAA homeostasis, and the treatments together will alter the global metabolic profile, as measured by 1H-NMR spectroscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

July 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2005

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

January 30, 2009

Status Verified

January 1, 2009

First QC Date

September 27, 2005

Last Update Submit

January 29, 2009

Conditions

Healthy

Keywords

oxidative stressamino acidsacetaminophendietary requirements

Eligibility Criteria

Age18 Months - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

healthy volunteers

You may qualify if:

  • healthy

You may not qualify if:

  • smokers greater or less than 10% of ideal body weight illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Study Officials

  • Dean P Jones, Ph.D.

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 27, 2005

First Posted

September 29, 2005

Study Start

July 1, 2005

Study Completion

January 1, 2009

Last Updated

January 30, 2009

Record last verified: 2009-01

Locations

US(1)