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Effects of Glutathione on Immunity in Individuals Training for a Marathon

U

University of North Texas, Denton, TX

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: Placebo Supplement
Dietary Supplement: Glutathione Supplement

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

84 patients

Sex

All

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

84 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Intervention: Dietary Supplement: Placebo supplement
Treatment:
Dietary Supplement: Placebo Supplement
Experimental: Glutathione
Experimental group
Description:
Intervention: Dietary Supplement: Glutathione supplement
Treatment:
Dietary Supplement: Glutathione Supplement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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