NCT03725241

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

October 29, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

1.5 years

First QC Date

October 5, 2018

Last Update Submit

November 17, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

  • Change in Complete Blood Count (CBC)

    CBC will be drawn and white blood cell count will be evaluated as an indicator of infection.

    Evaluated at baseline, week 12 and week 16

  • Change in Erythrocyte Sedimentation Rate (ESR)

    ESR will be measured as a marker of systematic inflammation

    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

    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

    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

    Evaluated at baseline, week 12 and week 16

Secondary Outcomes (4)

  • Survey based tracking of upper respiratory tract infection symptoms

    Continuous for 18 weeks

  • Incident specific tracking of upper respiratory tract infections (URTI)

    Continuous for 18 weeks

  • Changes in Thiobarbituric acid reactive substances (TBARs)

    Evaluated at baseline, week 12 and week 16

  • Changes in Glutathione (GSH)/Glutathione disulfide (GSSG) ratio in blood

    Evaluated at baseline, week 12 and week 16

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Intervention: Dietary Supplement: Placebo supplement

Dietary Supplement: Placebo Supplement

Experimental: Glutathione

EXPERIMENTAL

Intervention: Dietary Supplement: Glutathione supplement

Dietary Supplement: Glutathione Supplement

Interventions

Glutathione SupplementDIETARY_SUPPLEMENT

1000 mg/day Glutathione

Also known as: L-Glutathione reduced
Experimental: Glutathione
Placebo SupplementDIETARY_SUPPLEMENT

Crystalline cellulose

Also known as: Placebo
Placebo

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Texas

Denton, Texas, 76201, United States

Location

MeSH Terms

Interventions

Glutathione

Intervention Hierarchy (Ancestors)

OligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Brian K McFarlin, PhD

    University of North Texas, Denton, TX

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blind
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2018

First Posted

October 31, 2018

Study Start

October 29, 2018

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

November 19, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)