Improvement in Immune Cell Function in Elderly HumansNCT02316925
GSH Supplementation on Cold/Flu Symptoms in Older Healthy Adults
A study testing Setria glutathione supplement and Crystalline Cellulose in people with Improvement in Immune Cell Function in Elderly Humans, run by University of Florida.
Trial summary
A randomized, double blind placebo-controlled parallel intervention in adults over the age of 50 will be performed. Participants will receive a supplement capsule containing placebo (Crystalline Cellulose) or 500mg of Setria® Glutathione to eat for 120 days. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Improvement in Immune Cell Function in Elderly Humans
- What is being tested?
- Setria glutathione supplement and Crystalline Cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2015to May 2015
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- generally healthy
- must have had at least one cold during the previous year
- age 50-75
- must discontinue other dietary supplement use
Who cannot join
- on arthritis medication
- on hypertension medication
- severe allergies
- compromised immune system
- high cholesterol, heart failure, angina, etc.
- diagnoses of diabetes or metabolic syndrome
About this study
Official title: Oral Glutathione Supplementation on Cold/Flu Symptoms in Older Healthy Adults
A randomized, double blind placebo-controlled parallel intervention in adults over the age of 50 will be performed. Participants will receive a supplement capsule containing placebo (Crystalline Cellulose) or 500mg of Setria® Glutathione to eat for 120 days. 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. The primary end point is the number of healthy days experienced during cold and flu season. Secondary endpoints include cellular and biochemical measures from blood samples taken before and after the study.
Read the detailed description
The long term goal of this investigation is to understand how food components improve immune function, both in its ability to respond to pathogens and its ability to turn off when the response is no longer needed. The goal of this application is to examine mechanisms by which glutathione improves immune cells after consumption. The central hypothesis is that glutathione improves redox status within the cell, thereby improving cell function and increasing the number of healthy days experienced by the participants.
After obtaining informed consent, human participants will receive 500 mg/day of Setria® Glutathione or placebo for 120 days. 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. This study is powered on the basis that over 120 days, the glutathione-supplemented group would experience 3% more healthy days compared to the placebo group. The analysis indicated 60 people per group. Timeline should be between mid-January to May because the Center for Disease Control and Prevention indicates that this is the cold and flu season (http://www.cdc.gov/flu/weekly/fluactivity.htm) in the southwest part of the country.
- Being tested
- Setria glutathione supplement, Crystalline Cellulose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Setria glutathione supplementDietary supplement
Also called Setria
500 mg/day capsule taken in the morning
Crystalline CelluloseDietary supplement
Also called Placebo
500 mg/day capsule taken in the morning
| Study group | Role | What they receive |
|---|---|---|
| Crystalline Cellulose | Placebo comparator | looks like and is given in the same way as the experimental treatment but contains no active ingredient Receives: Dietary Supplement: Crystalline Cellulose |
| Glutathione supplement | Experimental | 500 mg/day Setria glutathione supplement Receives: Dietary Supplement: Setria glutathione supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity and frequency of Cold / Flu symptoms
Participants will record any cold / flu symptoms in log throughout the study duration
Measured: 120 days
Secondary outcomes (1)
Improvement of immune cell function
Increased neutrophil respiratory burst; IFN-gamma and other cytokine production measurements; γδ-T cell proliferation in mitogen-stimulated ex vivo culture
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startMay 2015
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: This study will never recruit. The protocol was renamed and will be resubmitted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improvement in Immune Cell Function in Elderly HumansStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Kyowa Hakko Bio Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Susan S Percival, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316925
- Sponsor's protocol ID
- IRB201400950
- Status last verified
- May 2015
- First submitted
- 10 Dec 2014
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Glutathione Supplementation on Cold/Flu Symptoms in Older Healthy Adults
- ClinicalTrials.gov ID
- NCT02316925
- Acronym / sponsor ID
- IRB201400950
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study will never recruit. The protocol was renamed and will be resubmitted.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Kyowa Hakko Bio Co., Ltd.
- Study start
- May 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 15 Dec 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.
A randomized, double blind placebo-controlled parallel intervention in adults over the age of 50 will be performed. Participants will receive a supplement capsule containing placebo (Crystalline Cellulose) or 500mg of Setria® Glutathione to eat for 120 days. 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. The primary end point is the number of healthy days experienced during cold and flu season. Secondary endpoints include cellular and biochemical measures from blood samples taken before and after the study.
Detailed description
The long term goal of this investigation is to understand how food components improve immune function, both in its ability to respond to pathogens and its ability to turn off when the response is no longer needed. The goal of this application is to examine mechanisms by which glutathione improves immune cells after consumption. The central hypothesis is that glutathione improves redox status within the cell, thereby improving cell function and increasing the number of healthy days experienced by the participants.
After obtaining informed consent, human participants will receive 500 mg/day of Setria® Glutathione or placebo for 120 days. 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. This study is powered on the basis that over 120 days, the glutathione-supplemented group would experience 3% more healthy days compared to the placebo group. The analysis indicated 60 people per group. Timeline should be between mid-January to May because the Center for Disease Control and Prevention indicates that this is the cold and flu season (http://www.cdc.gov/flu/weekly/fluactivity.htm) in the southwest part of the country.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crystalline Cellulose | Placebo comparator | Dietary Supplement: Crystalline Celluloselooks like and is given in the same way as the experimental treatment but contains no active ingredient |
| Glutathione supplement | Experimental | Dietary Supplement: Setria glutathione supplement500 mg/day Setria glutathione supplement |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- generally healthy
- must have had at least one cold during the previous year
- age 50-75
- must discontinue other dietary supplement use
Key exclusion criteria (6 listed)
- on arthritis medication
- on hypertension medication
- severe allergies
- compromised immune system
- high cholesterol, heart failure, angina, etc.
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 |
|---|---|---|
| Setria glutathione supplementAlso: Setria500 mg/day capsule taken in the morning | Dietary supplement | Glutathione supplement |
| Crystalline CelluloseAlso: Placebo500 mg/day capsule taken in the morning | Dietary supplement | Crystalline Cellulose |
Primary outcome
Severity and frequency of Cold / Flu symptoms
Time frame: 120 days
Participants will record any cold / flu symptoms in log throughout the study duration
1 secondary outcome
Improvement of immune cell function
Time frame: 120 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
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.
Susan S Percival, PhD principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
A study testing Setria glutathione supplement and Crystalline Cellulose in people with Improvement in Immune Cell Function in Elderly Humans, run by University of Florida.
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 6 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: withdrawn, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Severity and frequency of Cold / Flu symptoms (time frame: 120 days). 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 6 May 2015.