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NCT02348775 · ClinicalTrials.gov registry record · Phase 1
Glutathione and Function in HIV Patients
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT02348775 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 16 participants.
The verdict
NCT02348775, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
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.
Interventions
- DIETARY_SUPPLEMENT GlyNAC (combination of glycine and n-acetylcysteine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2014-11 |
| Est. Completion | 2020-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02348775
The ClinicalTrials.gov registry entry for NCT02348775 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which GlyNAC (combination of glycine and n-acetylcysteine) is the first listed.
NCT02348775 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02348775 about?
NCT02348775 is a clinical study titled "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 norma...
What is the current status of trial NCT02348775?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2014-11. Estimated completion is 2020-08.
What interventions are being tested in trial NCT02348775?
The interventions under investigation include: GlyNAC (combination of glycine and n-acetylcysteine) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02348775?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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