Effects of Glutathione (an Antioxidant) and N-Acetylcysteine on Inflammation

What Was Tested

In this not phased trial, researchers set out to test Glutathione for insulin resistance, prediabetes & type 2 diabetes.

Glutathione (GSH) is one of the body's most powerful antioxidant agents but there is a surprising paucity of data on its use as an interventional therapy.

Glutathione, when taken orally, is immediately broken down into its constituent amino acids, of which cysteine is the only one to be essential.

It had five arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as dietary supplement and other.

Who Took Part

78 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Gender: Both women and men. Age: \> or = 18 years. Ethnicity and race: All ethnic and racial backgrounds welcome. Central obesity as measured by waist circumference:. Men: Greater than 40 inches.

The full record lists 14 inclusion and 22 exclusion criteria; among the exclusions: daily intake of dietary supplements containing antioxidants or omega-3 fas; AST or ALT more than 2 times the upper limit of normal and/or; renal disease as measured at baseline:.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The insulin resistance, prediabetes & type 2 diabetes participants were allocated by chance, so the Glutathione group and the comparison group should start out alike.

Groups ran in parallel: each of the insulin resistance, prediabetes & type 2 diabetes participants stayed in one arm throughout.

Neither the insulin resistance, prediabetes & type 2 diabetes 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, investigator and outcomes assessor.

It started in 2011-06 with completion listed for 2012-07.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Inflammatory Markers (time frame: 8 weeks).

It also tracked 8 secondary outcomes, for example Oxidized LDL, Insulin Sensitivity, Weight, Blood pressure, Serum lipids and Insulin.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glutathione in 78 people with insulin resistance, prediabetes & type 2 diabetes.

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

More context: the Glutathione compound page, Insulin resistance, prediabetes & type 2 diabetes research.