Glutathione vs. Curcumin Clinical Trial

What Was Tested

This registered phase 1, phase 2 trial tested Glutathione.

The investigator proposes to perform a phase I/II study comparing two nutraceuticals and placebo that target mediators identified in the investigator's prior dynamic modeling study of Gulf War Illness (GWI).

The investigator will repeat the dynamic modeling before treatment and on therapy to assess the modeling and the impact of the interventions on the homeostatic networks that have identified, with an added focus on the glutathione/redox system.

It had three arms (groups): Curcumin (experimental), Liposomal Glutathione (experimental) and Placebo Liquid or Capsules (experimental).

The registry classes the interventions as drug and other.

More on the Plan

In the Investigator's prior study "Dynamic Modeling in GWI", the investigator used an exercise stress model (rest, peak oxygen consumption oxygen uptake, and 7 follow-up sampling points) to measure the mediators of relapse in the context of their interactive homeostatic networks.

The investigator surveyed the response of genes and blood-borne biomarkers in order to interrogate and map regulation of neuro-endocrine-autonomic-immune function in these subjects as compared to GW era sedentary healthy controls.

Who Took Part

Enrollment: 75 planned participants were the target.

It was open to people of any sex aged from 35 years up to 70 years.

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

Examples of who could join: 35 to 70 years old. Good health by medical history prior to 1990. Currently have no exclusionary diagnoses that could reasonably explain the symptoms of their fatiguing illness and their severity.

The full record lists 4 inclusion and 16 exclusion criteria; among the exclusions: major depression with psychotic or melancholic features; bipolar disorder; delusional disorders.

How the Study Was Run

The set-up was 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.

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

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

Those kept unaware of assignments: participant and care provider.

It started in 2016-04 with completion listed for 2019-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Biomarker response to therapy using a VO2 exercise test (time frame: 12 weeks). Biomarker response to therapy using cytokine panel (time frame: 12 weeks).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Glutathione in 75 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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