Glutathione and Function in HIV Patients

Study Overview
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Brief Summary
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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
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Detailed data are not as yet available

Official Title
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Glutathione and Function in HIV Patients

Conditions
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HIV Infection, Erythrocyte Glutathione Deficiency

Intervention / Treatment
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* Dietary Supplement: GlyNAC (combination of glycine and n-acetylcysteine)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV patients: age 45-65 years Non-HIV subjects: age 45-65 years Exclusion Criteria: Hospitalization in the past 3 months Untreated hypothyroidism or hyperthyroidism Known diabetes mellitus, hypercortisolemia, coronary artery disease. Known liver impairment (ALT and AST >2ULN) Renal impairment (Creatinine>1.4) Inability to walk Patients on anticoagulation or antiplatelet therapy. Patient with triglyceride concentrations >500 mg/dl.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GlyNAC<br>HIV infected subjects will be studied before and after taking oral glycine and n-acetylcysteine for 3 months | Dietary Supplement: GlyNAC (combination of glycine and n-acetylcysteine)<br>* HIV patients will be studied before and after receiving GlyNAC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Glutathione Concentration | Muscle glutathione concentrations measured by liquid chromatography | 20-weeks |