Glutathione (GSH) Supplementation After Hospitalization

January 21, 2022 updated by: Thomas R. Ziegler, MD, Emory University

Bioavailable Glutathione Supplementation: During Hospitalization and Beyond

The purpose of this study is to see if oral liquid glutathione treatment, has any effect on improving health-related cellular protection, muscle size and strength, and fatigue, weakness, and quality of life in older adults with a history of malnutrition who have been hospitalized. Persons enrolled in this study will be those initially admitted to Emory University Hospital (EUH) in Atlanta, GA, but recovering and ready to be discharged home or to an assisted living facility to eat an oral diet. A combination of nutritional measures, blood markers and imaging tools will assess body composition. Study participants will complete questionnaires about quality of life and physical health, and do simple testing for physical strength and stamina. Information from this pilot study will increase understanding of a simple intervention which may prevent or reduce health risks related to hospital recovery in older adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a single-center randomized, double blind, placebo-controlled, intent-to-treat clinical trial to test the impact of oral administration of liposomal glutathione (GSH) in initially hospitalized, malnourished, older adults after discharge to the home setting. Study subjects will be clinically stable and able to complete serial study endpoint investigations. A total of 50 clinically stable subjects will be block-randomized to receive either oral liposomal GSH or identical placebo product for 90 days after discharge from Emory University Hospital (EUH). Plasma GSH redox status over time will be the primary study endpoint. Secondary study endpoints will include other thiol/disulfide indexes of oxidative stress, body composition, and measures of physical function, mobility, fatigue, frailty and quality of life. All endpoints will be determined at baseline (just prior to hospital discharge) and repeated at 30, 60 and 90 days after hospital discharge to the home or assisted living environment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Admitted to Emory University Hospital (EUH) and residing at home (including assisted living settings) before and after hospitalization
  • Subject has voluntarily signed and dated an informed consent
  • Greater than or equal to 5 and no more than 15 consecutive overnight stays in an Emory University Hospital general ward and/or Surgical Intensive Care Unit (SICU) or Medical Intensive Care Unit (MICU) during the current hospital admission
  • Currently admitted to a general medical or surgical hospital ward at EUH and able to tolerate oral solid diet
  • Positive screening prior to entry for mild, moderate or severe malnutrition by standard Centers for Medicare/Medicaid Services (CMS) criteria after hospital admission
  • Currently mobile on hospital ward and able to be transported (wheelchair) to Clinical Research Unit for baseline testing
  • Functionally ambulatory (self-reported ability to walk across a small room without assistance) during the 30 days prior to admission
  • Ability to stand without assistance at the time of baseline testing
  • Body mass index (BMI) >18.5, <40 mg/kg2
  • Living within 40 miles of EUH

Exclusion Criteria:

  • Subject not expected to be discharged to usual home or assisted living setting
  • Requires tube feeding and/or parenteral nutrition in home/assisted living setting
  • Planned or elective re-hospitalization within 90 days of discharge
  • Inability to return to the EUH Clinical Research Unit for follow up study visits at 30, 60 and 90 days after entry into study
  • History of acute or chronic gastrointestinal tract disorder that, in the opinion of the principal investigator would preclude ingestion or absorption of the study product (e.g., prior gastric bypass surgery, short bowel syndrome, inflammatory bowel disease, celiac disease, acute/chronic pancreatitis, or chronic upper gastrointestinal bleeding
  • Current dementia, acute/chronic altered mental status, encephalopathy, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures in the opinion of the principal investigator
  • History of stroke with motor disability or other significant movement disorders precluding protocol functional strength testing
  • Acute hepatic failure during current hospitalization with total serum bilirubin > 3.5 mg/dL or transaminase values [alanine transaminase (ALT) and/or aspartate transaminase (AST) values > 3-fold the upper limit of normal range]
  • Chronic or acute renal failure requiring chronic dialysis in home/assisted living setting after discharge
  • Current active cancer or recently (within 6 months) treated cancer other than basal cell or squamous cell carcinoma of the skin or prostate cancer
  • Participation in another research protocol within 30 days of entry into the current study or within 60 days after entry
  • Any other condition or event considered exclusionary by the principal investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Liposomal Glutathione (GSH)
Participants will be randomized to receive two teaspoons containing 840 mg GSH (420 mg/tsp) twice daily for 90 days after discharge from Emory University Hospital (EUH).
Dietary supplement: Liposomal Glutathione (GSH)
Two teaspoons (containing 840 mg GSH, 420 mg/tsp) liposomal GSH (ReadiSorb®) will be taken orally twice daily for a total daily dose of 1680 mg GSH/day. Liposomal GSH will be refrigerated until use and mixed in ≈ 250 mL water or juice for oral intake. The study product will be consumed daily for 90 consecutive days after hospital discharge.
Other Names:
  • ReadiSorb®
Placebo Comparator: Placebo
Participants will be randomized to receive a placebo product identical to liposomal glutathione (GSH) twice daily for 90 days after discharge from Emory University Hospital (EUH).
Other: Placebo
Two teaspoons of placebo product will be taken orally twice daily. The placebo will be refrigerated until use and mixed in ≈ 250 mL water or juice for oral intake. The placebo will be consumed daily for 90 consecutive days after hospital discharge.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Plasma Concentrations of GSH
Time Frame: Baseline, Post Hospital Discharge (90 Days)
Plasma concentrations of GSH will be collected via blood draw.
Baseline, Post Hospital Discharge (90 Days)
Change in GSH/glutathione Disulfide (GSSG) Concentration Ratio
Time Frame: Baseline, Post Hospital Discharge (90 Days)
GSH concentrations will be compared to glutathione disulfide. Concentrations will be collected and analyzed via blood draw.
Baseline, Post Hospital Discharge (90 Days)
Change in GSH/GSSH Pool Redox Potential (Eh)
Time Frame: Baseline, Post Hospital Discharge (90 Days)
GSH and GSSH will be collected via blood draw. Redox potential is a measure of the tendency of a chemical species to acquire electrons and thereby be reduced. The more positive the potential, the greater the affinity for electrons and tendency to be reduced
Baseline, Post Hospital Discharge (90 Days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Composition assessed by Dual Energy X-ray Absorptiometry (DEXA) Scan
Time Frame: Baseline, Post Hospital Discharge (90 Days)
The DEXA scan will assess body composition by defining lean body mass, total fat mass, and visceral fat mass.
Baseline, Post Hospital Discharge (90 Days)
Change in Waist Circumference
Time Frame: Baseline, Post Hospital Discharge (90 Days)
Waist circumference will be measured in centimeters. Change is defined as the difference in measurements from baseline to 90 days post discharge.
Baseline, Post Hospital Discharge (90 Days)
Change in Hip Circumference
Time Frame: Baseline, Post Hospital Discharge (90 Days)
Hip circumference will be measured in centimeters. Change is defined as the difference in measurements from baseline to 90 days post discharge.
Baseline, Post Hospital Discharge (90 Days)
Change in Body Mass Index (BMI)
Time Frame: Baseline, Post Hospital Discharge (90 Days)
Body mass index (BMI) is a measure of body fat based on height and weight. A BMI below 18.5 = Underweight; 18.5 - 24.9 = Normal; 25.0 - 29.9 = Overweight; 30.0 and Above = Obese.
Baseline, Post Hospital Discharge (90 Days)
Change in Total Body Water (TBW) Volume
Time Frame: Baseline, Post Hospital Discharge (90 Days)
Body water is the water content that is contained in the tissues, the blood, the bones and elsewhere. The average TBW% ranges for a healthy adult are: Females - 45 to 60%, Males - 50 to 65%.
Baseline, Post Hospital Discharge (90 Days)
Change in Intracellular Water Volume assessed by Bioelectrical Impedance Analysis (BIA)
Time Frame: Baseline, Post Hospital Discharge (90 Days)
Intracellular water volume refers to water located within the cell. This will be measured by BIA, a method used for estimating body composition.
Baseline, Post Hospital Discharge (90 Days)
Change in Extracellular Water Volume assessed by Bioelectrical Impedance Analysis (BIA)
Time Frame: Baseline, Post Hospital Discharge (90 Days)
Extracellular water volume refers to water located outside of the cell. This will be measured by BIA, a method used for estimating body composition.
Baseline, Post Hospital Discharge (90 Days)
Change in Phase Angle Measurements assessed by Bioelectrical Impedance Analysis (BIA)
Time Frame: Baseline, Post Hospital Discharge (90 Days)
Phase angle is an indicator of cellular health and integrity. A low phase angle is consistent with an inability of cells to store energy and an indication of breakdown in the selective permeability of cellular membranes. A high phase angle is consistent with large quantities of intact cell membranes and body cell mass.
Baseline, Post Hospital Discharge (90 Days)
Change in Short Physical Performance Battery Score
Time Frame: Baseline, Post Hospital Discharge (90 Days)
The Short Physical Performance Battery (SPPB) is a tool to assess lower extremity physical performance status.The scores range from 0 (worst performance) to 12 (best performance).
Baseline, Post Hospital Discharge (90 Days)
Change in Timed Up and Go Test Score
Time Frame: Baseline, Post Hospital Discharge (90 Days)
The Timed Up and Go Test assesses mobility. Participants are asked to walk to a line 9.8 feet away, turn around at the line, and walk back at a normal pace. An older adult who takes ≥12 seconds to complete the TUG is at high risk for falling.
Baseline, Post Hospital Discharge (90 Days)
Change in Grip Strength assessed by Hand-Grip Dynamometry
Time Frame: Baseline, Post Hospital Discharge (90 Days)

Handgrip Dynamometers are instruments for measuring the maximum isometric strength of the hand and forearm muscles, used for testing handgrip strength. Hand muscle measurements are as follows:

Grade 5: full active range of motion & Normal muscle resistance Grade 4: full active range of motion & Reduced muscle resistance Grade 3: full active range of motion & No muscle resistance Grade 2: Reduced active range of motion & No muscle resistance Grade 1: No active range of motion & Palpable muscle contraction only Grade 0: No active range of motion & No palpable muscle contraction
Baseline, Post Hospital Discharge (90 Days)
Change in Life Space Assessment Questionnaire Score
Time Frame: Baseline, Post Hospital Discharge (90 Days)
The Life Space Assessment Questionnaire assesses how much the person gets out and about and the spatial extent of the person's typical life space, i.e., what is the usual range of places in which the person engages in activities within the designated time frame.
Baseline, Post Hospital Discharge (90 Days)
Change in Iowa Fatigue Scale Score
Time Frame: Baseline, Post Hospital Discharge (90 Days)
The Iowa Fatigue Scale assesses fatigue over the past month. General fatigue is a score between 30 and 39. Severe fatigue is a defined as a score between 40 - 55.
Baseline, Post Hospital Discharge (90 Days)
Change in Edmonton Frail Scale Score
Time Frame: Baseline, Post Hospital Discharge (90 Days)
The Edmonton Frail Scale assesses and stratifies frailty. Scores range from 0-5 "not frail", 6-7 "vulnerable", 8-9 "mild frailty", 10-11 "moderate frailty", and 12-17 "severe frailty".
Baseline, Post Hospital Discharge (90 Days)
Change in Fatigue Symptom Inventory (FSI) Score
Time Frame: Baseline, Post Hospital Discharge (90 Days)
The Fatigue Symptom Inventory (FSI), is a 14-item self-report measure designed to assess the severity, frequency, and daily pattern of fatigue as well as its perceived interference with quality of life.
Baseline, Post Hospital Discharge (90 Days)
Plasma Concentrations of Cysteine (Cys)
Time Frame: Baseline, Post Hospital Discharge (90 Days)
Plasma concentrations Cysteine (Cys) will be collected via blood draw.
Baseline, Post Hospital Discharge (90 Days)
Plasma Concentrations of Cistine (CySS)
Time Frame: Baseline, Post Hospital Discharge (90 Days)
Plasma concentrations CySS will be collected via blood draw.
Baseline, Post Hospital Discharge (90 Days)
Cys/CySS Ratio
Time Frame: Baseline, Post Hospital Discharge (90 Days)
Cys concentrations will be compared to CySS. Concentrations will be collected and analyzed via blood draw.
Baseline, Post Hospital Discharge (90 Days)
Cys/CySS Pool Redox Potential
Time Frame: Baseline, Post Hospital Discharge (90 Days)
Cys and CySS will be collected via blood draw. Redox potential is a measure of the tendency of a chemical species to acquire electrons and thereby be reduced. The more positive the potential, the greater the affinity for electrons and tendency to be reduced
Baseline, Post Hospital Discharge (90 Days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Your Energy Systems, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00095819

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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