Erythrocyte Glutathione Deficiency, HIV Infection
Conditions
Brief 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.
Detailed description
Detailed data are not as yet available
Interventions
DIETARY_SUPPLEMENTGlyNAC (combination of glycine and n-acetylcysteine)
HIV patients will be studied before and after receiving GlyNAC
Sponsors
Baylor College of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
HIV patients: * age 45-65 years Non-HIV subjects: * age 45-65 years
Exclusion criteria
1. Hospitalization in the past 3 months 2. Untreated hypothyroidism or hyperthyroidism 3. Known diabetes mellitus, hypercortisolemia, coronary artery disease. 4. Known liver impairment (ALT and AST \>2ULN) 5. Renal impairment (Creatinine\>1.4) 6. Inability to walk 7. Patients on anticoagulation or antiplatelet therapy. 8. Patient with triglyceride concentrations \>500 mg/dl.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Glutathione Concentration | 20-weeks | Muscle glutathione concentrations measured by liquid chromatography |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cysteine/Glycine 8 HIV infected subjects were studied before and after taking oral cysteine (as n-acetylcysteine) and glycine for 3 months, and compared to 8 uninfected controls
Cysteine (as n-acetylcysteine) and glycine: Only HIV patients were studied before and after receiving cysteine and glycine | 8 |
| No Supplements 8 uninfected participants served as controls and were not supplemented | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | Cysteine/Glycine | No Supplements | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 8 Participants | 16 Participants |
| Age, Continuous | 54.9 years STANDARD_DEVIATION 4.4 | 55 years STANDARD_DEVIATION 3.6 | 55 years STANDARD_DEVIATION 4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 8 Participants | 16 Participants |
| Region of Enrollment United States | 8 participants | 8 participants | 16 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Muscle Glutathione Concentration
Muscle glutathione concentrations measured by liquid chromatography
Time frame: 20-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GlyNAC | Muscle Glutathione Concentration | 0.5 micromol/g.Hb | Standard Deviation 0.2 |
| Control Arm | Muscle Glutathione Concentration | 2.2 micromol/g.Hb | Standard Deviation 0.8 |