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OpenTrials
Completed

NCT Number: NCT02348775

Glutathione and Function in HIV Patients

We have recently reported that older patients with HIV are deficient in glutathione (GSH) due to decreased availability of cysteine and glycine, and that oral supplementation with cysteine (as n-acetylcysteine) and glycine for 2-weeks corrects their own levels, and improves (but does not fully normalize) concentrations of red-cell GSH. We also found that when GSH deficient, subjects had impaired mitochondrial fuel oxidation and this improved with an increase in intracellular GSH concentrations. These older HIV patients also had significant increases in muscle strength with improvement of GSH levels.The current proposal in older HIV patients will investigate study if cysteine and glycine supplementation for a duration of 12 weeks will result in changes in : (a) GSH levels; (b) body composition/anthropometry; (c) strength and function; (d) quality of life; (e) mitochondrial energetics; (f) biochemistry (including dyslipidemia and oxidative stress); (g) protein and glucose metabolism; (h) cognition and memory. After completing supplementation for 3 months, GSH concentrations, strength, function, mitochondrial energetics and neurocognitive tests will be measured for a further 2 months to determine the effects of washout.

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Key information

About this study

Detailed data are not as yet available

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

HIV patients:

  • age 45-65 years

Non-HIV subjects:

  • age 45-65 years

Exclusion criteria

  • Hospitalization in the past 3 months
  • Untreated hypothyroidism or hyperthyroidism
  • Known diabetes mellitus, hypercortisolemia, coronary artery disease.
  • Known liver impairment (ALT and AST >2ULN)
  • Renal impairment (Creatinine>1.4)
  • Inability to walk
  • Patients on anticoagulation or antiplatelet therapy.
  • Patient with triglyceride concentrations >500 mg/dl.

Treatment and study plan

GlyNAC (combination of glycine and n-acetylcysteine)

Dietary Supplement

HIV patients will be studied before and after receiving GlyNAC

Primary outcomes

  1. Muscle Glutathione Concentration

    Time frame: 20-weeks

    Muscle glutathione concentrations measured by liquid chromatography

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2020
First posted
Jan 28, 2015
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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