HealthyNCT03725241
Effects of Glutathione on Immunity in Individuals Training for a Marathon
A study testing Glutathione Supplement in people with Healthy, run by University of North Texas, Denton, TX at 1 site in United States.
Trial summary
The aim of this study is to determine the effects of glutathione supplement on the immune cell response and symptomatology of upper respiratory health, and antioxidant capacity in healthy people in exercise-induced model. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Glutathione Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2018to 1 May 2020
- 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 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy, male or female.
- Between the ages of 19-45 years.
- Have no medical restrictions and no health conditions that would inhibit participant from marathon run.
- Be willing and able to comfortably abstain from any food supplements.
- Not participating as a subject in another study.
Who cannot join
- BMI < 20.0 or > 28.5.
- Current or prior use of tobacco products or other inhaled substance.
- More than a moderate intake of alcohol (>1 drink per day in women; >2 drinks per day in men).
- Metabolic or inflammatory disease.
- Excellent fitness based on the American College of Sports Medicine criteria for VO2max based on age and gender.
- Recent weight loss of >10 pounds in the last 3-months.
Show all 20Show fewer
- Daily intake of ibuprofen, acetaminophen, aspirin, polyphenol supplements, multivitamins, and/or antioxidant supplements.
- Actively attempting (or planning) to lose or gain weight and/or alter body composition.
- Currently taking cholesterol-lowering medications.
- Currently taking prescription anti-inflammatory medications.
- Currently using mouthwash on a regular basis (>4 times per week).
- Orthopedic problems that would limit running capacity.
- Currently in very poor or poor fitness.
- Highly aerobic exercise trained.
- Pregnant or planning to become pregnant during the study period.
- Breast feeding
- Currently taking blood pressure medications.
- Contraindications to strenuous exercise.
- Anemic (blood hemoglobin <10 g/dL and/or hematocrit <35%).
- Diagnosed with asthma or other lung disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Daily Supplementation With Glutathione Alter Immunity, Upper Respiratory Tract Infection, and Oxidative Stress in Individuals Training for a Half Marathon Race
The aim of this study is to determine the effects of glutathione supplement on the immune cell response and symptomatology of upper respiratory health, and antioxidant capacity in healthy people in exercise-induced model.
Read the detailed description
A minimum of 60 individuals will be recruited and enrolled to complete the entire protocol in a randomized, double-blinded, 18 week placebo-controlled trial. Subjects will receive either a placebo or glutathione while participating in a stepwise exercise approach that mixes periods of high and low training volume to train subjects and improve running efficiency. Upper Respiratory Tract Infection-related health conditions will be monitored and assessed throughout the study period. Blood and saliva samples will be collected at baseline, and before and after timed 15k and half marathon runs at 12 and 16 weeks respectively.
- Conditions
- Healthy
- Being tested
- Glutathione Supplement, Placebo Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glutathione SupplementDietary supplement
Also called L-Glutathione reduced
1000 mg/day Glutathione
Placebo SupplementDietary supplement
Also called Placebo
Crystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Intervention: Dietary Supplement: Placebo supplement Receives: Dietary Supplement: Placebo Supplement |
| Experimental: Glutathione | Experimental | Intervention: Dietary Supplement: Glutathione supplement Receives: Dietary Supplement: Glutathione Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Complete Blood Count (CBC)
CBC will be drawn and white blood cell count will be evaluated as an indicator of infection.
Measured: Evaluated at baseline, week 12 and week 16
Change in Erythrocyte Sedimentation Rate (ESR)
ESR will be measured as a marker of systematic inflammation
Measured: Evaluated at baseline, week 12 and week 16
Change in mucosal immunity
Salivary Immunoglobulin concentrations will be tracked as a marker of the bodies ability to mount a first line defense against viruses and other pathogens
Measured: Evaluated at baseline, week 12 and week 16
Change in T-cell population
Shifts in the T-cell concentration and population phenotypes will be tracked as a marker for readiness to fight infection
Measured: Evaluated at baseline, week 12 and week 16
Change in T-cell response to Group A Streptococci Antigen
Measurements will provide insight regarding the in vitro capacity of the body to respond to the most common virus causing URTI
Measured: Evaluated at baseline, week 12 and week 16
Secondary outcomes (4)
Survey based tracking of upper respiratory tract infection symptoms
Tracking of symptoms allows for calculation of % healthy vs % sick days
Measured: Continuous for 18 weeks
Incident specific tracking of upper respiratory tract infections (URTI)
Incidence tracking of URTI allows for evaluation of comparative number, severity and recovery time from URTI
Measured: Continuous for 18 weeks
Changes in Thiobarbituric acid reactive substances (TBARs)
TBARs are a direct index of the state of lipid peroxidation which is a marker of oxidative stress
Measured: Evaluated at baseline, week 12 and week 16
Changes in Glutathione (GSH)/Glutathione disulfide (GSSG) ratio in blood
The ratio of reduced glutathione to oxidized glutathione will be analyzed as a marker of oxidative stress and antioxidant capacity
Measured: Evaluated at baseline, week 12 and week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start29 Oct 2018
- Primary completion1 May 2020
- Study completion1 May 2020
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.
- 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Texas, Denton, TX
- Sponsor type
- University, hospital or other
- Collaborators
- Kirin Holdings Company, Limited
- Responsible party
- Sponsor
- Investigators
- Brian K McFarlin, PhD, Principal investigator, University of North Texas, Denton, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725241
- Sponsor's protocol ID
- 18-100
- Status last verified
- Nov 2020
- First submitted
- 5 Oct 2018
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Daily Supplementation With Glutathione Alter Immunity, Upper Respiratory Tract Infection, and Oxidative Stress in Individuals Training for a Half Marathon Race
- ClinicalTrials.gov ID
- NCT03725241
- Acronym / sponsor ID
- 18-100
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of North Texas, Denton, TXUniversity, hospital or other
- Collaborators
- Kirin Holdings Company, Limited
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 31 Oct 2018 (actual)
- 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.
The aim of this study is to determine the effects of glutathione supplement on the immune cell response and symptomatology of upper respiratory health, and antioxidant capacity in healthy people in exercise-induced model.
Detailed description
A minimum of 60 individuals will be recruited and enrolled to complete the entire protocol in a randomized, double-blinded, 18 week placebo-controlled trial. Subjects will receive either a placebo or glutathione while participating in a stepwise exercise approach that mixes periods of high and low training volume to train subjects and improve running efficiency. Upper Respiratory Tract Infection-related health conditions will be monitored and assessed throughout the study period. Blood and saliva samples will be collected at baseline, and before and after timed 15k and half marathon runs at 12 and 16 weeks respectively.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo SupplementIntervention: Dietary Supplement: Placebo supplement |
| Experimental: Glutathione | Experimental | Dietary Supplement: Glutathione SupplementIntervention: Dietary Supplement: Glutathione supplement |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Generally healthy, male or female.
- Between the ages of 19-45 years.
- Have no medical restrictions and no health conditions that would inhibit participant from marathon run.
- Be willing and able to comfortably abstain from any food supplements.
- Not participating as a subject in another study.
Key exclusion criteria (20 listed)
- BMI < 20.0 or > 28.5.
- Current or prior use of tobacco products or other inhaled substance.
- More than a moderate intake of alcohol (>1 drink per day in women; >2 drinks per day in men).
- Metabolic or inflammatory disease.
- Excellent fitness based on the American College of Sports Medicine criteria for VO2max based on age and gender.
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 SupplementAlso: L-Glutathione reduced1000 mg/day Glutathione | Dietary supplement | Experimental: Glutathione |
| Placebo SupplementAlso: PlaceboCrystalline cellulose | Dietary supplement | Placebo |
Primary outcome
Change in Complete Blood Count (CBC)
Time frame: Evaluated at baseline, week 12 and week 16
CBC will be drawn and white blood cell count will be evaluated as an indicator of infection.
Change in Erythrocyte Sedimentation Rate (ESR)
Time frame: Evaluated at baseline, week 12 and week 16
ESR will be measured as a marker of systematic inflammation
Change in mucosal immunity
Time frame: Evaluated at baseline, week 12 and week 16
Salivary Immunoglobulin concentrations will be tracked as a marker of the bodies ability to mount a first line defense against viruses and other pathogens
Change in T-cell population
Time frame: Evaluated at baseline, week 12 and week 16
Shifts in the T-cell concentration and population phenotypes will be tracked as a marker for readiness to fight infection
Change in T-cell response to Group A Streptococci Antigen
Time frame: Evaluated at baseline, week 12 and week 16
Measurements will provide insight regarding the in vitro capacity of the body to respond to the most common virus causing URTI
4 secondary outcomes
Survey based tracking of upper respiratory tract infection symptoms
Time frame: Continuous for 18 weeks
Incident specific tracking of upper respiratory tract infections (URTI)
Time frame: Continuous for 18 weeks
Changes in Thiobarbituric acid reactive substances (TBARs)
Time frame: Evaluated at baseline, week 12 and week 16
Changes in Glutathione (GSH)/Glutathione disulfide (GSSG) ratio in blood
Time frame: Evaluated at baseline, week 12 and week 16
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 19 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Brian K McFarlin, PhD principal investigator
University of North Texas, Denton, TX
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 Supplement in people with Healthy, run by University of North Texas, Denton, TX 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 5 inclusion and 20 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 19 Nov 2020. 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?
Change in Complete Blood Count (CBC) (time frame: Evaluated at baseline, week 12 and week 16). The study lists 5 primary outcomes in all. 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 19 Nov 2020.