The Effects of a Glutathione Precursor (FT061452),on Serum and Intracellular Glutathione Levels

What Was Tested

This registered phase 1 trial tested Glutathione.

Glutathione is a powerful protective substance found within every cell in the body.

N-Acetyl Cysteine is used as a dietary supplement.

It had six arms (groups): one (placebo comparator), one (active comparator), Proimmune 200(FT061452) (active comparator), one (placebo comparator) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

Glutathione (gamma-glutamyl-cysteine-glycine; GSH) is a powerful antioxidant found within every cell.

GSH is predominantly known to protect the cells from damage caused by free radicals.

The concentration of glutathione declines with age, stress, and in some age-related diseases.

When glutathione becomes deficient, a series of events are initiated termed "oxidative stress" and the associated cell signaling leads to impaired immune function and similar abnormalities in numerous cell systems.

Who Took Part

24 actual participants took part.

It was open to people of any sex aged from 30 years up to 65 years.

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

Examples of who could join: Subjects will be healthy male or female, 30 to 65 years of age. Subjects must have a BMI between 20 and 35. Subjects must be non-smoking (defined as a subject who has not smoked for ≥ 6 months), and must agree to abstain from caffeine 72 hours prior to study day. Subjects are in generally good health, based on pre-study medical history, physical examination and routine laboratory tests.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: subjects who have a history of drug or alcohol abuse within 6 months of study screening, as determined by the investigator; subjects who have any condition that interferes with their ability to understand or comply with the requirements of the study; females who are pregnant or nursing or have a high likelihood of becoming pregnant during the study.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Glutathione study: the participants and staff both knew the treatment.

It started in 2010-12 with completion listed for 2011-06.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Intracellular Glutathione Level (time frame: 6 hours).

It also tracked 1 secondary outcome, for example Augmentation Index.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glutathione in 24 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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