Oral Glutathione Supplementation in Older Healthy Adults and Its Effect on the Number of Healthy Days Experienced During Four Months of Supplementation Compared to Placebo
GSH
1 other identifier
interventional
124
1 country
1
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 the duration of the study. Secondary endpoints include cellular and biochemical measures from blood samples taken before and after the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2015
Typical duration for not_applicable
1 active site
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
May 6, 2015
CompletedFirst Posted
Study publicly available on registry
May 8, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedOctober 24, 2017
October 1, 2017
8 months
May 6, 2015
October 20, 2017
Conditions
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 COMPARATORlooks like and is given in the same way as the experimental treatment but contains no active ingredient
Glutathione supplement
EXPERIMENTAL500 mg/day Setria glutathione supplement
Interventions
500 mg/day capsule taken in the morning for 120 days.
500 mg/day capsule taken in the morning for 120 days.
Eligibility Criteria
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
- University of Floridalead
- Kyowa Hakko Bio Co., Ltd.collaborator
Study Sites (1)
449 Food Science and Human Nutrition Department, University of Florida
Gainesville, Florida, 32611, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Susan S Percival, PhD
University of Florida
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
May 6, 2015
First Posted
May 8, 2015
Study Start
October 1, 2015
Primary Completion
June 1, 2016
Study Completion
September 1, 2017
Last Updated
October 24, 2017
Record last verified: 2017-10