HealthyNCT02278822
Oral Liposomal Glutathione Supplementation in Healthy Subjects
A study testing Low dose oral liposomal glutathione supplementation and High dose oral liposomal glutathione supplementation in people with Healthy, 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 liposomal glutathione supplementation on healthy adults. The investigators anticipate that liposomal glutathione supplementation will enhance the levels of blood glutathione and improve the immune functions. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Low dose oral liposomal glutathione supplementation and High dose oral liposomal glutathione supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Mar 2016
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy English-speaking male and female volunteers
- Baseline blood glutathione level of ≤ 0.9 mmol/l
- Non-smoking individuals
Who cannot join
- No history or evidence of disease including cancer, diabetes, heart disease.
- Not taking glutathione as a dietary supplement
- Not taking high-dose antioxidant supplements
Trial locations and contacts
1 site in 1 country.
United States1 site
M.S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Pilot Study of Oral Liposomal Glutathione Supplementation on Levels of Glutathione in Blood and Biomarkers of Oxidative Stress and Immune Function in Healthy Adults
This trial is designed to provide evidence of the efficacy of liposomal glutathione supplementation on healthy adults. The investigators anticipate that liposomal glutathione supplementation will enhance the levels of blood glutathione and improve the immune functions.
Read the detailed description
This is a randomized study on healthy individuals. The study design includes the recruitment of 12 healthy male and female subjects (50-80 yr of age) randomized into 2 groups of 6 each (liposomal glutathione at 500 mg/day or liposomal glutathione at 1000 mg/day). Blood and urine samples will be obtained from all subjects 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, liposomal glutathione (500 mg daily), Group B, liposomal glutathione (1000 mg daily)
Eligible participants who sign the informed consent will be randomly assigned to either low dose or high 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 liposomal glutathione between subjects. 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.
Levels of glutathione will be measured in whole blood, erythrocytes, lymphocytes and plasma. The biomarkers of oxidative stress will include urinary 8-isoprostane and urinary 8-hydroxydeoxyguanosine. Immune function biomarkers will be analyzed including lymphocyte proliferation and natural killer (NK) cell cytotoxicity.
- Conditions
- Healthy
- Being tested
- Low dose oral liposomal glutathione supplementation, High dose oral liposomal glutathione supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose oral liposomal glutathione supplementationOther
Low dose oral liposomal glutathione supplementation
High dose oral liposomal glutathione supplementationOther
High dose oral liposomal glutathione supplementation
| Study group | Role | What they receive |
|---|---|---|
| Low dose oral liposomal glutathione | Experimental | Intervention: low dose oral liposomal glutathione supplementation. 500 mg oral liposomal glutathione each day for 4 weeks. Receives: Other: Low dose oral liposomal glutathione supplementation |
| High dose oral liposomal glutathione | Experimental | Intervention: high dose oral liposomal glutathione supplementation. 1000 mg oral liposomal glutathione each day for 4 weeks. Receives: Other: High dose oral liposomal glutathione supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glutathione levels in blood
Measured: Baseline and 4 weeks
Secondary outcomes (1)
Measure immune function biomarkers in blood
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raghu Sinha, Milton S. Hershey Medical Center
- Investigators
- Raghu Sinha, PhD, Principal investigator, M.S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278822
- Sponsor's protocol ID
- STUDY00000405
- Status last verified
- Jul 2016
- First submitted
- 11 Oct 2014
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Oral Liposomal Glutathione Supplementation on Levels of Glutathione in Blood and Biomarkers of Oxidative Stress and Immune Function in Healthy Adults
- ClinicalTrials.gov ID
- NCT02278822
- Acronym / sponsor ID
- STUDY00000405
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 30 Oct 2014 (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 liposomal glutathione supplementation on healthy adults. The investigators anticipate that liposomal glutathione supplementation will enhance the levels of blood glutathione and improve the immune functions.
Detailed description
This is a randomized study on healthy individuals. The study design includes the recruitment of 12 healthy male and female subjects (50-80 yr of age) randomized into 2 groups of 6 each (liposomal glutathione at 500 mg/day or liposomal glutathione at 1000 mg/day). Blood and urine samples will be obtained from all subjects 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, liposomal glutathione (500 mg daily), Group B, liposomal glutathione (1000 mg daily)
Eligible participants who sign the informed consent will be randomly assigned to either low dose or high 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 liposomal glutathione between subjects. 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.
Levels of glutathione will be measured in whole blood, erythrocytes, lymphocytes and plasma. The biomarkers of oxidative stress will include urinary 8-isoprostane and urinary 8-hydroxydeoxyguanosine. Immune function biomarkers will be analyzed including lymphocyte proliferation and natural killer (NK) cell cytotoxicity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose oral liposomal glutathione | Experimental | Other: Low dose oral liposomal glutathione supplementationIntervention: low dose oral liposomal glutathione supplementation. 500 mg oral liposomal glutathione each day for 4 weeks. |
| High dose oral liposomal glutathione | Experimental | Other: High dose oral liposomal glutathione supplementationIntervention: high dose oral liposomal glutathione supplementation. 1000 mg oral liposomal glutathione each day for 4 weeks. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy English-speaking male and female volunteers
- Baseline blood glutathione level of ≤ 0.9 mmol/l
- Non-smoking individuals
Key exclusion criteria (3 listed)
- No history or evidence of disease including cancer, diabetes, heart disease.
- Not taking glutathione as a dietary supplement
- Not taking high-dose antioxidant supplements
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 |
|---|---|---|
| Low dose oral liposomal glutathione supplementationLow dose oral liposomal glutathione supplementation | Other | Low dose oral liposomal glutathione |
| High dose oral liposomal glutathione supplementationHigh dose oral liposomal glutathione supplementation | Other | High dose oral liposomal glutathione |
Primary outcome
Glutathione levels in blood
Time frame: Baseline and 4 weeks
1 secondary outcome
Measure immune function biomarkers in blood
Time frame: Baseline and 4 weeks
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 11 Jul 2016.
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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.
Raghu Sinha, PhD principal investigator
M.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 Low dose oral liposomal glutathione supplementation and High dose oral liposomal glutathione supplementation in people with Healthy, 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 3 inclusion and 3 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 11 Jul 2016. 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. 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?
Glutathione levels in blood (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2016.