Effects of Glutathione on Immunity in Individuals Training for a Marathon

What Was Tested

The trial (not phased) is built around Glutathione.

The aim of this study is to determine the effects of glutathione supplement on the immune cell response and symptomatology of upper respiratory health, and antioxidant capacity in healthy people in exercise-induced model.

It had two arms (groups): Placebo (placebo comparator) and Experimental: Glutathione (experimental).

Intervention: Dietary Supplement: Placebo supplement.

Intervention: Dietary Supplement: Glutathione supplement.

The registry classes the interventions as dietary supplement.

More on the Plan

A minimum of 60 individuals will be recruited and enrolled to complete the entire protocol in a randomized, double-blinded, 18 week placebo-controlled trial.

Upper Respiratory Tract Infection-related health conditions will be monitored and assessed throughout the study period.

Blood and saliva samples will be collected at baseline, and before and after timed 15k and half marathon runs at 12 and 16 weeks respectively.

Who Took Part

The registry lists 84 actual participants took part.

It was open to people of any sex aged from 19 years up to 45 years.

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

Examples of who could join: Generally healthy, male or female. Between the ages of 19-45 years. Have no medical restrictions and no health conditions that would inhibit participant from marathon run. Be willing and able to comfortably abstain from any food supplements. Not participating as a subject in another study.

The full record lists 5 inclusion and 20 exclusion criteria; among the exclusions: BMI \< 20.0 or \> 28.5; current or prior use of tobacco products or other inhaled substance; more than a moderate intake of alcohol (\>1 drink per day in women; \>2 drinks per day in men).

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.

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 2018-10-29 with completion listed for 2020-05-01.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Change in Complete Blood Count (CBC) (time frame: Evaluated at baseline, week 12 and week 16). Change in Erythrocyte Sedimentation Rate (ESR) (time frame: Evaluated at baseline, week 12 and week 16). Change in mucosal immunity (time frame: Evaluated at baseline, week 12 and week 16).

It also tracked 4 secondary outcomes, for example Survey based tracking of upper respiratory tract infection symptoms, Incident specific tracking of upper respiratory tract infections (URTI), Changes in Thiobarbituric acid reactive substances (TBARs) and Changes in Glutathione (GSH)/Glutathione disulfide (GSSG) ratio in blood.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glutathione in 84 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.