NCT02278822

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Nov 2014

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 11, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

5 months

First QC Date

October 11, 2014

Last Update Submit

July 7, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Glutathione levels in blood

    Baseline and 4 weeks

Secondary Outcomes (1)

  • Measure immune function biomarkers in blood

    Baseline and 4 weeks

Study Arms (2)

Low dose oral liposomal glutathione

EXPERIMENTAL

Intervention: low dose oral liposomal glutathione supplementation. 500 mg oral liposomal glutathione each day for 4 weeks.

Other: Low dose oral liposomal glutathione supplementation

High dose oral liposomal glutathione

EXPERIMENTAL

Intervention: high dose oral liposomal glutathione supplementation. 1000 mg oral liposomal glutathione each day for 4 weeks.

Other: High dose oral liposomal glutathione supplementation

Interventions

Low dose oral liposomal glutathione supplementationOTHER

Low dose oral liposomal glutathione supplementation

Low dose oral liposomal glutathione
High dose oral liposomal glutathione supplementationOTHER

High dose oral liposomal glutathione supplementation

High dose oral liposomal glutathione

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M.S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Study Officials

  • Raghu Sinha, PhD

    M.S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Biochemistry and Molecular Biology

Study Record Dates

First Submitted

October 11, 2014

First Posted

October 30, 2014

Study Start

November 1, 2014

Primary Completion

April 1, 2015

Study Completion

March 1, 2016

Last Updated

July 11, 2016

Record last verified: 2016-07

Locations

US(1)