Clinical Trials Directory

Trials / Completed

CompletedNCT01355198

Role of HIV on Glutathione Synthesis and Oxidative Stress

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
10 (actual)
Sponsor
Baylor College of Medicine · Academic / Other
Sex
Male
Age
21 Years – 70 Years
Healthy volunteers
Not accepted

Summary

HIV infection is associated the development of increased oxidative stress and deficiency of glutathione (GSH), the dominant endogenous antioxidant protein, but the underlying mechanisms contributing to GSH deficiency are hitherto unknown. Furthermore GSH metabolism has not been studied in HIV patients, in whom the burden of risk factors promoting oxidative stress is highest. Our previous studies in non-HIV human subjects with diabetes-related oxidative stress and GSH deficiency have demonstrated that the latter is due to decreased synthesis of GSH. Importantly, short-term dietary supplementation with the simple GSH precursor amino-acids cysteine and glycine, boosted GSH synthesis and cellular concentrations, corrected GSH deficiency, and reduced oxidative stress and oxidant damage. The current proposal will study whether (1) defective synthesis underlies GSH deficiency in patients with HIV, and will test a simple, inexpensive and rational therapy based on protein supplementation to improve GSH synthesis and concentrations and lower markers of oxidative stress and oxidant damage in these patients; (2) study if correction of GSH deficiency is asssociated with any changes in (a) impaired mitochondrial fuel oxidation in the fasted and insulin stimulated states; (b) insulin sensitivity; (c) body composition and anthropometry; (d) forearm muscle strength; (e) plasma biochemistry, and (f) quality of life indices in these subjects.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTCysteine (as n-acetylcysteine) and glycineCysteine and glycine will be supplemented at doses of 0.81 mmol/kg/d and 1.31 mmol/kg/d for 2 weeks each
DIETARY_SUPPLEMENTCysteine/glycineSubjects will receive oral dietary amino-acids (cystiene as n-acetylcysteine, and glycine)

Timeline

Start date
2010-08-01
Primary completion
2011-09-01
Completion
2011-09-01
First posted
2011-05-18
Last updated
2013-02-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01355198. Inclusion in this directory is not an endorsement.