Oral Glutathione Supplementation on the Levels of Blood Glutathione

What Was Tested

In this not phased trial, researchers set out to test Glutathione.

Based on previous laboratory animal studies and clinical data, the investigators anticipate that the effects of oral GSH supplementation will be progressive and cumulative.

The study will also allow for the evaluation of effects of withdrawal of the supplement on the outcome variables.

It had three arms (groups): Group A (experimental), Group B (experimental) and Group C (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

This is a randomized double-blind, placebo-controlled study in which the treatment allocations will be kept sealed until the final statistical evaluation.

The design will include the recruitment of 60 healthy subjects (30-79 yr of age) randomized into 3 groups.

A total of 48 subjects, 16 per group will be required based upon power calculations and results from a previous clinical trial with selenium.

An additional 4 subjects per group will be placed on trial to account for possible attrition or non-compliance.

Who Took Part

The registry lists 61 actual participants took part.

It was open to people of any sex aged from 30 years up to 79 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy male and females between the ages of 30 and 79 years of age. Not taking glutathione as a dietary supplement.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: history or evidence of disease including cancer, diabetes, heart disease; subjects who smoke.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Glutathione group and the comparison group should start out alike.

The Glutathione group and the comparison group ran side by side rather than switching.

As a double-blind Glutathione study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2010-02 with completion listed for 2011-09.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Evaluation of the effect of glutathione on key biomarkers (time frame: 6 to 7 months).

It also tracked 1 secondary outcome, for example Evaluations will be carried out to expand the above comparison by including adjustments for potential prognostic factors.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glutathione in 61 people.

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.