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Completed

NCT Number: NCT02278822

Oral Liposomal Glutathione Supplementation in Healthy Subjects

This trial is designed to provide evidence of the efficacy of liposomal glutathione supplementation on healthy adults. The investigators anticipate that liposomal glutathione supplementation will enhance the levels of blood glutathione and improve the immune functions.

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Key information

Conditions

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M.S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

This is a randomized study on healthy individuals. The study design includes the recruitment of 12 healthy male and female subjects (50-80 yr of age) randomized into 2 groups of 6 each (liposomal glutathione at 500 mg/day or liposomal glutathione at 1000 mg/day). Blood and urine samples will be obtained from all subjects at baseline. Eligible subjects will be required to have not have taken any high dose antioxidant supplements for at least 1 month prior to the study. Subjects will then begin supplementation according to the following schedule: Group A, liposomal glutathione (500 mg daily), Group B, liposomal glutathione (1000 mg daily)

Eligible participants who sign the informed consent will be randomly assigned to either low dose or high dose glutathione groups. Participants will be asked not to consume any other high-dose vitamin, multi-vitamin, or mineral supplements containing glutathione throughout the study in order to prevent variation in dose of supplemental liposomal glutathione between subjects. Participants are to limit their consumption of alcohol in the study to no more than 5 oz. of alcohol per week. Supplementation will continue for 1 month with biological samples collected at 1, 2 and 4 weeks after baseline.

Levels of glutathione will be measured in whole blood, erythrocytes, lymphocytes and plasma. The biomarkers of oxidative stress will include urinary 8-isoprostane and urinary 8-hydroxydeoxyguanosine. Immune function biomarkers will be analyzed including lymphocyte proliferation and natural killer (NK) cell cytotoxicity.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy English-speaking male and female volunteers
  • Baseline blood glutathione level of ≤ 0.9 mmol/l
  • Non-smoking individuals

Exclusion criteria

  • No history or evidence of disease including cancer, diabetes, heart disease.
  • Not taking glutathione as a dietary supplement
  • Not taking high-dose antioxidant supplements

Treatment and study plan

Low dose oral liposomal glutathione supplementation

Other

Low dose oral liposomal glutathione supplementation

High dose oral liposomal glutathione supplementation

Other

High dose oral liposomal glutathione supplementation

Primary outcomes

  1. Glutathione levels in blood

    Time frame: Baseline and 4 weeks

Secondary outcomes

  1. Measure immune function biomarkers in blood

    Time frame: Baseline and 4 weeks

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

Pilot Study of Oral Liposomal Glutathione Supplementation on Levels of Glutathione in Blood and Biomarkers of Oxidative Stress and Immune Function in Healthy Adults

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Oct 30, 2014
Registry last updated
Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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