An interventional study of Liposomal Glutathione (GSH) and Placebo in Malnutrition, sponsored by Emory University. Withdrawn. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2022-01-25.
Sponsored by Emory University · Not applicable, Interventional, and Treatment
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.
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.
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
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Exclusion Criteria:
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)
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 (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.
Also known as: ReadiSorb®
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.
Change in Plasma Concentrations of GSH
Plasma concentrations of GSH will be collected via blood draw.
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in GSH/glutathione Disulfide (GSSG) Concentration Ratio
GSH concentrations will be compared to glutathione disulfide. Concentrations will be collected and analyzed via blood draw.
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in GSH/GSSH Pool Redox Potential (Eh)
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
Time frame: Baseline, Post Hospital Discharge (90 Days)
Body Composition assessed by Dual Energy X-ray Absorptiometry (DEXA) Scan
The DEXA scan will assess body composition by defining lean body mass, total fat mass, and visceral fat mass.
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Waist Circumference
Waist circumference will be measured in centimeters. Change is defined as the difference in measurements from baseline to 90 days post discharge.
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Hip Circumference
Hip circumference will be measured in centimeters. Change is defined as the difference in measurements from baseline to 90 days post discharge.
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Body Mass Index (BMI)
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.
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Total Body Water (TBW) Volume
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%.
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Intracellular Water Volume assessed by Bioelectrical Impedance Analysis (BIA)
Intracellular water volume refers to water located within the cell. This will be measured by BIA, a method used for estimating body composition.
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Extracellular Water Volume assessed by Bioelectrical Impedance Analysis (BIA)
Extracellular water volume refers to water located outside of the cell. This will be measured by BIA, a method used for estimating body composition.
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Phase Angle Measurements assessed by Bioelectrical Impedance Analysis (BIA)
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.
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Short Physical Performance Battery Score
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).
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Timed Up and Go Test Score
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.
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Grip Strength assessed by Hand-Grip Dynamometry
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
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Life Space Assessment Questionnaire Score
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.
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Iowa Fatigue Scale Score
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.
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Edmonton Frail Scale Score
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".
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Fatigue Symptom Inventory (FSI) Score
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.
Time frame: Baseline, Post Hospital Discharge (90 Days)
Plasma Concentrations of Cysteine (Cys)
Plasma concentrations Cysteine (Cys) will be collected via blood draw.
Time frame: Baseline, Post Hospital Discharge (90 Days)
Plasma Concentrations of Cistine (CySS)
Plasma concentrations CySS will be collected via blood draw.
Time frame: Baseline, Post Hospital Discharge (90 Days)
Cys/CySS Ratio
Cys concentrations will be compared to CySS. Concentrations will be collected and analyzed via blood draw.
Time frame: Baseline, Post Hospital Discharge (90 Days)
Cys/CySS Pool Redox Potential
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
Time frame: Baseline, Post Hospital Discharge (90 Days)
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