- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03166371
Glutathione (GSH) Supplementation After Hospitalization
Bioavailable Glutathione Supplementation: During Hospitalization and Beyond
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
|
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:
|
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).
|
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
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
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00095819
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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