NCT00253760

Brief Summary

Varied food intake, disease, and genetic differences result in complex diet-health interactions. In principle, information-rich metabolic analyses combined with bioinformatic tools provide an approach to explore these interactions. This project is a feasibility study of the use of high-resolution 1H-nuclear magnetic resonance (NMR) to study metabolic perturbations induced by a deficiency in sulfur amino acids (SAA). The investigators will 1) test the hypothesis that deficient dietary intake of SAA in humans results in oxidation of reduced glutathione (GSH)/oxidized glutathione (GSSG) redox and 2) determine whether 1H-NMR of blood and urine detects metabolic changes due to SAA deficiency.

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 not_applicable

Timeline
Completed

Started Feb 2004

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

March 18, 2010

Status Verified

March 1, 2010

First QC Date

November 14, 2005

Last Update Submit

March 17, 2010

Conditions

Oxidative StressDiabetesHeart Diseases

Keywords

redoxsulfur amino acidsglutathioneaging

Outcome Measures

Primary Outcomes (2)

  • redox state of the two central low molecular weight thiol-disulfide pools, i.e., GSH/GSSG and cysteine (Cys)/cystine (CySS)

  • a global metabolic spectrum detectable by H-NMR

Interventions

dietary amino acids; cysteine and methionineDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal weight
  • Males or females

You may not qualify if:

  • Smokers
  • Pregnancy
  • Chronic illness other than hypertension
  • Age less than 18 and greater than 40 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Diabetes MellitusHeart Diseases

Interventions

CysteineMethionine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, SulfurSulfur CompoundsOrganic ChemicalsSulfhydryl CompoundsAmino Acids, NeutralAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Dean P Jones, Ph.D.

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

November 14, 2005

First Posted

November 15, 2005

Study Start

February 1, 2004

Study Completion

February 1, 2007

Last Updated

March 18, 2010

Record last verified: 2010-03

Locations

US(1)