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Oral Liposomal Glutathione Supplementation in Healthy Subjects

Plain-language guide to NCT02278822: not phased randomized trial of Glutathione, 12 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT02278822
Phase
not phased
Status
completed
Start
2014-11
Completion (planned or actual)
2015-04
Participants
12 (actual)
Design
randomized, open label (everyone knows who gets what), basic_science
Conditions studied
Healthy
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Glutathione.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as other.

More on the Plan

This is a randomized study on healthy individuals.

Blood and urine samples will be obtained from all subjects at baseline.

Participants are to limit their consumption of alcohol in the study to no more than 5 oz. of alcohol per week.

Supplementation will continue for 1 month with biological samples collected at 1, 2 and 4 weeks after baseline.

Who Took Part

Enrollment: 12 actual participants took part.

It was open to people of any sex aged from 50 years up to 80 years.

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

Examples of who could join: Healthy English-speaking male and female volunteers.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: no history or evidence of disease including cancer, diabetes, heart disease; not taking glutathione as a dietary supplement.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Everyone knew when Glutathione was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2014-11 with completion listed for 2015-04.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Glutathione levels in blood (time frame: Baseline and 4 weeks).

It also tracked 1 secondary outcome, for example Measure immune function biomarkers in blood.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glutathione in 12 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.

Our Notes on the Compound

Glutathione: The body's main antioxidant.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.