AgingPhase 1NCT02348762
Energetics and Function in Older Humans
A Phase 1 study testing Cysteine (as n-acetylcysteine) and Glycine in people with Aging and Erythrocyte Glutathione Deficiency, run by Baylor College of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Erythrocyte Glutathione Deficiency, Muscle Weakness
- What is being tested?
- Cysteine (as n-acetylcysteine) and Glycine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older subjects:
- age 70-80 years;
- Younger subjects:
- age 21-30 years
Who cannot join
- No known diabetes, liver disease, kidney disease, coronary heart disease, stroke, or cancer;
- Any limitations in ability to walk;
- Triglyceride concentrations greater than 500 mg/dl (if lipid lowering medications are stopped);
- BMI less than 20.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Metabolic Research Unit (MRU)
Houston, Texas, 77030
About this study
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.
Read the detailed description
Data not available at present
- Conditions
- Aging, Erythrocyte Glutathione Deficiency, Muscle Weakness
- Being tested
- Cysteine (as n-acetylcysteine) and Glycine
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cysteine (as n-acetylcysteine) and GlycineDietary supplement
Older subjects will be studied before and after receiving cysteine and glycine
| Study group | Role | What they receive |
|---|---|---|
| Glycine and N-acetylcysteine | Experimental | Older subjects will be studied before and after taking oral cysteine (as n-acetylcysteine) and glycine for 6 months Receives: Dietary Supplement: Cysteine (as n-acetylcysteine) and Glycine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red blood cell concentrations of Glutathione measured by HPLC
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2018
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajagopal V Sekhar, Baylor College of Medicine
- Investigators
- R V Sekhar, M.D., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348762
- Sponsor's protocol ID
- H-34686 Glutathione and Aging
- Status last verified
- Jan 2022
- First submitted
- 15 Jan 2015
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energetics and Function in Older Humans
- ClinicalTrials.gov ID
- NCT02348762
- Acronym / sponsor ID
- H-34686 Glutathione and Aging
- Conditions
- Aging, Erythrocyte Glutathione Deficiency, Muscle Weakness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2018 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Data not available at present
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glycine and N-acetylcysteine | Experimental | Dietary Supplement: Cysteine (as n-acetylcysteine) and GlycineOlder subjects will be studied before and after taking oral cysteine (as n-acetylcysteine) and glycine for 6 months |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 70-80 years;
- age 21-30 years
Key exclusion criteria (4 listed)
- No known diabetes, liver disease, kidney disease, coronary heart disease, stroke, or cancer;
- Any limitations in ability to walk;
- Triglyceride concentrations greater than 500 mg/dl (if lipid lowering medications are stopped);
- BMI less than 20.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cysteine (as n-acetylcysteine) and GlycineOlder subjects will be studied before and after receiving cysteine and glycine | Dietary supplement | Glycine and N-acetylcysteine |
Primary outcome
Red blood cell concentrations of Glutathione measured by HPLC
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Aging
Enrolling by invitationPhase 2
Tirzepatide and Organ-specific Biological Aging
Longevity, Preventive Medicine
Active, not recruiting
Emotional Well-being and Measures of Healthy Aging
Aging, Aging, Healthy
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Active, not recruiting
Vascular Aging and Lp299v Study in Healthy Adults
Vascular Aging
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R V Sekhar, M.D. principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cysteine (as n-acetylcysteine) and Glycine in people with Aging and Erythrocyte Glutathione Deficiency, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Red blood cell concentrations of Glutathione measured by HPLC (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.