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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02348762
The ClinicalTrials.gov registry entry for NCT02348762 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, below the 2,195-participant average among 262 other Aging trials with a reported enrollment target (99% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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