Glutathione and Its Precursors in HIV-Infected Patients

What Was Tested

In this phase 2 trial, researchers set out to test Glutathione.

The aim of this study is to investigate the responses of the serum amyloid A (SAA) pathway to dietary supplements of glutamine (Gln) and cysteine (Cys) together with methionine (Met)-overloading in HIV+ patients comparatively to healthy controls.

It had two arms (groups): Patient Group (experimental) and Control Group (active comparator).

The registry classes the interventions as dietary supplement.

More on the Plan

Introduction: Among the 4 sulphur-containing amino acids (SAA), only Met and Cys are incorporated into proteins, but Hcy and Tau are related to oxidative stress and glutathione (GSH), the major intracellular hydro-soluble anti-oxidant agent.

HIV+ patients present low levels of antioxidant nutrients, including GSH and its precursors.

Objective: To investigate the responses of the SAA pathway to dietary supplements of Gln and Cys together with Met-overloading in HIV+ patients comparatively to healthy controls.

HPLC plasma analysis of SAA (Met, Hcy, Cys and Tau), GSH and GSSG and Ser, Gly, Glu and Gln was carried out at moments before (MO) and after 7-day diets (M1).

Who Took Part

32 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Antiretroviral therapy for at least one year.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: presence of any renal or liver failure; ingestion of either vitamins b or gsh precursors.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

Because people in this Glutathione study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Glutathione and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on Glutathione, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and outcomes assessor.

It started in 2002-02 with completion listed for 2007-02.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Plasma glutathione (time frame: 7 days).

It also tracked 1 secondary outcome, for example Plasma sulfur amino acids.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glutathione in 32 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glutathione compound page, all human trials.