The Production of Reactive Oxygen Species in Response to Glutathione Supplementation and Acute Exercise

What Was Tested

This registered not phased trial tested Glutathione.

Objectives: The research focus of the study is the production of reactive oxygen species (ROS) in patients with type 2 diabetes (T2D) in response to glutathione (GSH) supplementation and in response to acute exercise.

GSH is the most abundant endogenous antioxidant in the cell and thus, a crucial protector against oxidative stress and insulin resistance.

It had two arms (groups): Control (placebo comparator) and Glutathione (active comparator).

4 placebo tablets/day (2 in the morning and 2 in the evening).

4 oral GSH tablets/day (2 in the morning and 2 in the evening).

The registry classes the interventions as dietary supplement and other.

More on the Plan

The link between ROS and skeletal muscle insulin resistance has been established both in vitro and in vivo (2, 3), but few studies have actually measured ROS production in skeletal muscle of T2D patients (4-6).

Mitochondria are a source of ROS, and also a major target of oxidative damage (7).

The mitochondrial defense system against oxidative stress relies on endogenous antioxidants.

Glutathione (GSH) is the most abundant endogenous antioxidant in the cell and thus, a crucial protector against oxidative stress and insulin resistance (8).

Who Took Part

20 actual participants took part.

It was open to men only aged from 30 years up to 50 years.

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

Examples of who could join: ECG with no evidence of heart disease. ECG with no evidence of Heart disease.

The full record lists 9 inclusion and 5 exclusion criteria; among the exclusions: insulin treatment; antioxidant supplementation or other dietary supplements; cholesterol lowering medicine.

How the Study Was Run

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

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.

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

Blinding on both sides kept the participants and researchers unaware of who received Glutathione.

Those kept unaware of assignments: participant and investigator.

It started in 2016-05 with completion listed for 2017-12.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Insulin sensitivity (time frame: 12 weeks).

It also tracked 1 secondary outcome, for example Mitochondrial reactive oxygen species production.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glutathione in 20 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.