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Oral Glutathione Supplementation in Older Healthy Adults and Its Effect on the Number of Healthy Days Experienced During Four Months of Supplementation Compared to Placebo
Plain-language guide to NCT02438956: not phased randomized trial of Glutathione, 124 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02438956
- Phase
- not phased
- Status
- completed
- Start
- 2015-10
- Completion (planned or actual)
- 2016-06
- Participants
- 124 (actual)
- Design
- randomized, double-blind, basic_science
- Conditions studied
- Improvement in Immune Cell Function in Elderly Humans
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Glutathione.
A randomized, double blind placebo-controlled parallel intervention in adults over the age of 50 will be performed.
Glutathione is hypothesized to replenish the body's reserves that may be depleted through natural aging process, poor diet, or due to the detoxification process for drugs.
It had two arms (groups): Crystalline Cellulose (placebo comparator) and Glutathione supplement (experimental).
Looks like and is given in the same way as the experimental treatment but contains no active ingredient.
The registry classes the interventions as dietary supplement.
More on the Plan
Peripheral blood mononuclear cells (PBMC), neutrophils and serum will be obtained from blood draws before and after the 120 days.
A daily diary of illness will be kept by each participant and will record any incidence of illness, the number of symptoms per incidence, and the number of days in which symptoms are present.
The analysis indicated 60 people per group.
Who Took Part
124 actual participants took part.
It was open to people of any sex aged from 50 years up to 75 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Must have had at least one cold during the previous year. Must discontinue other dietary supplement use.
The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: on arthritis medication; on hypertension medication; severe allergies.
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.
The Glutathione group and the comparison group ran side by side rather than switching.
As a double-blind Glutathione study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant and investigator.
It started in 2015-10 with completion listed for 2016-06.
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: Severity and frequency of Cold / Flu symptoms (time frame: 120 days).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Glutathione in 124 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.
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.