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NCT02348762 · ClinicalTrials.gov registry record · Phase 1
Energetics and Function in Older Humans
A Phase 1 study of Aging and Muscle Weakness, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT02348762: Completed Phase 1 study of Aging and Muscle Weakness, sponsored by Baylor College of Medicine.
NCT02348762 is a Phase 1 study of Aging and Muscle Weakness that has completed, run by Baylor College of Medicine. The registered enrollment target is 16 participants, below the 2,195-participant average among 262 other Aging trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02348762, a Phase 1 study of Aging and Muscle Weakness, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators have previously 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 concentrations of red-cell GSH. The investigators also found that when GSH deficient, subjects had impaired mitochondrial energetics and this improved with an increase in intracellular GSH concentrations. The current proposal will investigate if cysteine and glycine supplementation for a duration of 24 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. 3 months after completing supplementation, measurement of GSH concentrations, strength, function, mitochondrial energetics and neurocognitive tests will be done to determine the effects of washout.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Cysteine (as n-acetylcysteine) and Glycine
Study Locations (1)
Texas
- Baylor Metabolic Research Unit (MRU) - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2014-11 |
| Est. Completion | 2021-03 |
| Phase | Phase 1 |
What the finished NCT02348762 record still lists
NCT02348762 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 2,195-participant average among 262 other Aging trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Aging appearing as the primary indexed condition, and to 1 intervention - of which Cysteine (as n-acetylcysteine) and Glycine is the first listed.
NCT02348762 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02348762 about?
NCT02348762 is a clinical study titled "Energetics and Function in Older Humans". The investigators have previously 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 concentr...
What is the current status of trial NCT02348762?
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 2021-03.
What conditions does trial NCT02348762 study?
This clinical trial studies the following conditions: Aging, Muscle Weakness, Erythrocyte Glutathione Deficiency.
What interventions are being tested in trial NCT02348762?
The interventions under investigation include: Cysteine (as n-acetylcysteine) and Glycine (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02348762?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02348762 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02348762's enrollment target sits among peer trials
16 246th of 262 higher than 13 of 262 other Aging trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aging trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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