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Effects of Glutathione on Immunity in Individuals Training for a Marathon

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ClinicalTrials.gov Identifier: NCT03725241
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : November 6, 2018
Sponsor:
Collaborator:
Kyowa Hakko Bio Co., Ltd.
Information provided by (Responsible Party):
University of North Texas, Denton, TX

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Glutathione Supplement Dietary Supplement: Placebo Supplement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double blind
Primary Purpose: Basic Science
Official Title: Does Daily Supplementation With Glutathione Alter Immunity, Upper Respiratory Tract Infection, and Oxidative Stress in Individuals Training for a Half Marathon Race
Actual Study Start Date : October 29, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Glutathione

Arm Intervention/treatment
Placebo Comparator: Placebo
Intervention: Dietary Supplement: Placebo supplement
Dietary Supplement: Placebo Supplement
Crystalline cellulose
Other Name: Placebo

Experimental: Experimental: Glutathione
Intervention: Dietary Supplement: Glutathione supplement
Dietary Supplement: Glutathione Supplement
1000 mg/day Glutathione
Other Name: L-Glutathione reduced




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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


Secondary Outcome Measures :
  1. Survey based tracking of upper respiratory tract infection symptoms [ Time Frame: Continuous for 18 weeks ]
    Tracking of symptoms allows for calculation of % healthy vs % sick days

  2. Incident specific tracking of upper respiratory tract infections (URTI) [ Time Frame: Continuous for 18 weeks ]
    Incidence tracking of URTI allows for evaluation of comparative number, severity and recovery time from URTI

  3. Changes in Thiobarbituric acid reactive substances (TBARs) [ Time Frame: Evaluated at baseline, week 12 and week 16 ]
    TBARs are a direct index of the state of lipid peroxidation which is a marker of oxidative stress

  4. Changes in Glutathione (GSH)/Glutathione disulfide (GSSG) ratio in blood [ Time Frame: Evaluated at baseline, week 12 and week 16 ]
    The ratio of reduced glutathione to oxidized glutathione will be analyzed as a marker of oxidative stress and antioxidant capacity



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03725241


Contacts
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Contact: Brian K McFarlin, PhD 940-565-3165 Brian.Mcfarlin@unt.edu

Locations
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United States, Texas
University of North Texas Recruiting
Denton, Texas, United States, 76201
Contact: Brian K McFarlin, PhD    940-565-3165    brian.mcfarlin@unt.edu   
Principal Investigator: Brian K McFarlin, PhD         
Sponsors and Collaborators
University of North Texas, Denton, TX
Kyowa Hakko Bio Co., Ltd.
Investigators
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Principal Investigator: Brian K McFarlin, PhD University of North Texas Health Science Center

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Responsible Party: University of North Texas, Denton, TX
ClinicalTrials.gov Identifier: NCT03725241     History of Changes
Other Study ID Numbers: 18-100
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Respiratory Tract Infections
Infection
Respiratory Tract Diseases