Healthy AdultsNCT01044277
Oral Glutathione Supplementation on the Levels of Blood Glutathione
A study testing Glutathione supplementation and Gluthathione peroxidases in people with Healthy Adults, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
This trial is designed to provide evidence of the efficacy of glutathione supplementation and health(GSH) and includes the assessment of both short term and long term effects. Based on previous laboratory animal studies and clinical data, the investigators anticipate that the effects of oral GSH supplementation will… Read more about this study
- Who is it for?
- Ages 30 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Glutathione supplementation and Gluthathione peroxidases
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and females between the ages of 30 and 79 years of age
- Not taking glutathione as a dietary supplement
- Not taking high dose antioxidant supplement prior to 1 month
- Baseline blood glutathione level of < 1 mmol/L
Who cannot join
- History or evidence of disease including cancer, diabetes, heart disease
- Subjects who smoke
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Effect of Oral Glutathione Supplementation on the Levels of Blood Glutathione and Markers of Oxidative Stress in Healthy Adults (Glutathione Supplementation and Health (GSH) Study)
This trial is designed to provide evidence of the efficacy of glutathione supplementation and health(GSH) and includes the assessment of both short term and long term effects. Based on previous laboratory animal studies and clinical data, the investigators anticipate that the effects of oral GSH supplementation will be progressive and cumulative. The study will also allow for the evaluation of effects of withdrawal of the supplement on the outcome variables.
Read the detailed description
This is a randomized double-blind, placebo-controlled study in which the treatment allocations will be kept sealed until the final statistical evaluation. The design will include the recruitment of 60 healthy subjects (30-79 yr of age) randomized into 3 groups. A total of 48 subjects, 16 per group will be required based upon power calculations and results from a previous clinical trial with selenium. An additional 4 subjects per group will be placed on trial to account for possible attrition or non-compliance. Blood, urine and exfoliated buccal mucosal samples will be obtained from all subjects at baseline. Questionnaire data on usual dietary intake will also be obtained at baseline. Eligible subjects will be required to have not have taken any high dose antioxidant supplements for at least 1 month prior to the study. Subjects will then begin supplementation according to the following schedule:
Group A, GSH (500 mg, 2 times daily); Group B, GSH (125 mg, 2 times daily); Group C, placebo (2 times daily). Eligible participants who sign the informed consent will be randomly assigned to either placebo or high or low dose Glutathione groups. Participants will be asked not to consume any other high-dose vitamin, multi-vitamin, or mineral supplements containing glutathione throughout the study in order to prevent variation in dose of supplemental GSH between subjects. Supplementation will continue for 6 months with biological samples collected at 1, 3 and 6 months after baseline. At 6 months, supplementation will be discontinued. A final collection of biological samples will occur 1 month afterwards. Compliance will be monitored by pill count.
Levels of glutathione will be measured in plasma, lymphocytes, and red blood cells as well as in exfoliated buccal mucosal cells. Biomarkers of oxidative stress will include blood levels of glutathionylated proteins and 8-isoprostanes and urine levels of 8-hydroxydeoxyguanosine. Glutamylcystine ligase and GST activities, and C-reactive protein will be determined in blood. Immune function biomarkers will be analyzed including t-natural killer cell cytotoxicity, lymphoproliferation, neutrophils phagocytosis, neutrophil respiratory burst assays.
- Conditions
- Healthy Adults
- Being tested
- Glutathione supplementation, Gluthathione peroxidases, Placebo
- Keywords
- glutathione, gluthathione peroxidases, GSH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glutathione supplementationDrug
Also called Gluthathione Peroxidates, GSH
500 mg, two times daily
Gluthathione peroxidasesDrug
Also called Glutathione supplementation, GSH
125 mg, two times daily
PlaceboOther
Also called Gluthathione peroxidases, GSH
2 times daily
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Glutathione supplementation-Double-Blind - GSH 500 mg/GSH 125 mg/Placebo
Other name Gluthathione peroxidases Receives: Drug: Glutathione supplementation |
| Group B | Experimental | Glutathione supplementation-Double-Blind - GSH 500 mg/GSH 125 mg/Placebo
Other name Gluthathione peroxidases Receives: Drug: Gluthathione peroxidases |
| Group C | Placebo comparator | Placebo-Double-Blind - GSH 500 mg/GSH 125 mg/Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the effect of glutathione on key biomarkers
Blood glutathione status
Measured: 6 to 7 months
Secondary outcomes (1)
Evaluations will be carried out to expand the above comparison by including adjustments for potential prognostic factors.
Biomarkers of oxidative stress and immune function
Measured: 6 to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionSep 2011
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John P. Richie, Milton S. Hershey Medical Center
- Investigators
- John P. Richie, Ph.D., Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044277
- Sponsor's protocol ID
- PSHCI 09-059
- Status last verified
- Aug 2022
- First submitted
- 6 Jan 2010
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this time we have no plan for sharing, however, if the need should arise, then sharing may be a possibility.
Publications
Richie JP Jr, Nichenametla S, Neidig W, Calcagnotto A, Haley JS, Schell TD, Muscat JE. Randomized controlled trial of oral glutathione supplementation on body stores of glutathione. Eur J Nutr. 2015 Mar;54(2):251-63. doi: 10.1007/s00394-014-0706-z. Epub 2014 May 5.
PubMed 24791752
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Glutathione Supplementation on the Levels of Blood Glutathione and Markers of Oxidative Stress in Healthy Adults (Glutathione Supplementation and Health (GSH) Study)
- ClinicalTrials.gov ID
- NCT01044277
- Acronym / sponsor ID
- PSHCI 09-059
- Conditions
- Healthy Adults
- Keywords
- glutathione, gluthathione peroxidases, GSH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 7 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is designed to provide evidence of the efficacy of glutathione supplementation and health(GSH) and includes the assessment of both short term and long term effects. Based on previous laboratory animal studies and clinical data, the investigators anticipate that the effects of oral GSH supplementation will be progressive and cumulative. The study will also allow for the evaluation of effects of withdrawal of the supplement on the outcome variables.
Detailed description
This is a randomized double-blind, placebo-controlled study in which the treatment allocations will be kept sealed until the final statistical evaluation. The design will include the recruitment of 60 healthy subjects (30-79 yr of age) randomized into 3 groups. A total of 48 subjects, 16 per group will be required based upon power calculations and results from a previous clinical trial with selenium. An additional 4 subjects per group will be placed on trial to account for possible attrition or non-compliance. Blood, urine and exfoliated buccal mucosal samples will be obtained from all subjects at baseline. Questionnaire data on usual dietary intake will also be obtained at baseline. Eligible subjects will be required to have not have taken any high dose antioxidant supplements for at least 1 month prior to the study. Subjects will then begin supplementation according to the following schedule:
Group A, GSH (500 mg, 2 times daily); Group B, GSH (125 mg, 2 times daily); Group C, placebo (2 times daily). Eligible participants who sign the informed consent will be randomly assigned to either placebo or high or low dose Glutathione groups. Participants will be asked not to consume any other high-dose vitamin, multi-vitamin, or mineral supplements containing glutathione throughout the study in order to prevent variation in dose of supplemental GSH between subjects. Supplementation will continue for 6 months with biological samples collected at 1, 3 and 6 months after baseline. At 6 months, supplementation will be discontinued. A final collection of biological samples will occur 1 month afterwards. Compliance will be monitored by pill count.
Levels of glutathione will be measured in plasma, lymphocytes, and red blood cells as well as in exfoliated buccal mucosal cells. Biomarkers of oxidative stress will include blood levels of glutathionylated proteins and 8-isoprostanes and urine levels of 8-hydroxydeoxyguanosine. Glutamylcystine ligase and GST activities, and C-reactive protein will be determined in blood. Immune function biomarkers will be analyzed including t-natural killer cell cytotoxicity, lymphoproliferation, neutrophils phagocytosis, neutrophil respiratory burst assays.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Glutathione supplementationGlutathione supplementation-Double-Blind - GSH 500 mg/GSH 125 mg/Placebo Other name Gluthathione peroxidases |
| Group B | Experimental | Drug: Gluthathione peroxidasesGlutathione supplementation-Double-Blind - GSH 500 mg/GSH 125 mg/Placebo Other name Gluthathione peroxidases |
| Group C | Placebo comparator | Other: PlaceboPlacebo-Double-Blind - GSH 500 mg/GSH 125 mg/Placebo |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male and females between the ages of 30 and 79 years of age
- Not taking glutathione as a dietary supplement
- Not taking high dose antioxidant supplement prior to 1 month
- Baseline blood glutathione level of < 1 mmol/L
Key exclusion criteria (2 listed)
- History or evidence of disease including cancer, diabetes, heart disease
- Subjects who smoke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glutathione supplementationAlso: Gluthathione Peroxidates, GSH500 mg, two times daily | Drug | Group A |
| Gluthathione peroxidasesAlso: Glutathione supplementation, GSH125 mg, two times daily | Drug | Group B |
| PlaceboAlso: Gluthathione peroxidases, GSH2 times daily | Other | Group C |
Primary outcome
Evaluation of the effect of glutathione on key biomarkers
Time frame: 6 to 7 months
Blood glutathione status
1 secondary outcome
Evaluations will be carried out to expand the above comparison by including adjustments for potential prognostic factors.
Time frame: 6 to 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Derived from this study: PubMed 24791752Richie JP Jr, Nichenametla S, Neidig W, Calcagnotto A, Haley JS, Schell TD, Muscat JE. Randomized controlled trial of oral glutathione supplementation on body stores of glutathione. Eur J Nutr. 2015 Mar;54(2):251-63. doi: 10.1007/s00394-014-0706-z. Epub 2014 May 5.
- Individual participant dataSharing planned: Undecided. At this time we have no plan for sharing, however, if the need should arise, then sharing may be a possibility.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John P. Richie, Ph.D. principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glutathione supplementation and Gluthathione peroxidases in people with Healthy Adults, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the effect of glutathione on key biomarkers (time frame: 6 to 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01044277, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2022.