NCT02316925

Brief Summary

A randomized, double blind placebo-controlled parallel intervention in adults over the age of 50 will be performed. Participants will receive a supplement capsule containing placebo (Crystalline Cellulose) or 500mg of Setria® Glutathione to eat for 120 days. Glutathione is hypothesized to replenish the body's reserves that may be depleted through natural aging process, poor diet, or due to the detoxification process for drugs. The primary end point is the number of healthy days experienced during cold and flu season. Secondary endpoints include cellular and biochemical measures from blood samples taken before and after the study.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2015

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 15, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 6, 2015

Status Verified

May 1, 2015

Enrollment Period

Same day

First QC Date

December 10, 2014

Last Update Submit

May 4, 2015

Conditions

Improvement in Immune Cell Function in Elderly Humans

Outcome Measures

Primary Outcomes (1)

  • Severity and frequency of Cold / Flu symptoms

    Participants will record any cold / flu symptoms in log throughout the study duration

    120 days

Secondary Outcomes (1)

  • Improvement of immune cell function

    120 days

Study Arms (2)

Crystalline Cellulose

PLACEBO COMPARATOR

looks like and is given in the same way as the experimental treatment but contains no active ingredient

Dietary Supplement: Crystalline Cellulose

Glutathione supplement

EXPERIMENTAL

500 mg/day Setria glutathione supplement

Dietary Supplement: Setria glutathione supplement

Interventions

Setria glutathione supplementDIETARY_SUPPLEMENT

500 mg/day capsule taken in the morning

Also known as: Setria
Glutathione supplement
Crystalline CelluloseDIETARY_SUPPLEMENT

500 mg/day capsule taken in the morning

Also known as: Placebo
Crystalline Cellulose

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • generally healthy
  • must have had at least one cold during the previous year
  • age 50-75
  • must discontinue other dietary supplement use

You may not qualify if:

  • on arthritis medication
  • on hypertension medication
  • severe allergies
  • compromised immune system
  • high cholesterol, heart failure, angina, etc.
  • diagnoses of diabetes or metabolic syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Susan S Percival, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

December 10, 2014

First Posted

December 15, 2014

Study Start

May 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 6, 2015

Record last verified: 2015-05