Glutathione and Function in HIV Patients

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2020-08-31

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.

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Detailed Description

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Detailed data are not as yet available

Conditions

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HIV Infection Erythrocyte Glutathione Deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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GlyNAC

HIV infected subjects will be studied before and after taking oral glycine and n-acetylcysteine for 3 months

Group Type EXPERIMENTAL

GlyNAC (combination of glycine and n-acetylcysteine)

Intervention Type DIETARY_SUPPLEMENT

HIV patients will be studied before and after receiving GlyNAC

Interventions

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GlyNAC (combination of glycine and n-acetylcysteine)

HIV patients will be studied before and after receiving GlyNAC

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes