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Trial record 16 of 580 for:    reduced glutathione

Glutathione (GSH) Supplementation After Hospitalization

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ClinicalTrials.gov Identifier: NCT03166371
Recruitment Status : Recruiting
First Posted : May 25, 2017
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Your Energy Systems, LLC
Information provided by (Responsible Party):
Thomas R. Ziegler, MD, Emory University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malnutrition Dietary Supplement: Liposomal Glutathione (GSH) Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Bioavailable Glutathione Supplementation: During Hospitalization and Beyond
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
Drug Information available for: Glutathione

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).
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 Name: 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.




Primary Outcome Measures :
  1. Change in Plasma Concentrations of GSH [ Time Frame: Baseline, Post Hospital Discharge (90 Days) ]
    Plasma concentrations of GSH will be collected via blood draw.

  2. 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.

  3. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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%.

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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.

  11. 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


  12. 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.

  13. 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.

  14. 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".

  15. 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.

  16. Plasma Concentrations of Cysteine (Cys) [ Time Frame: Baseline, Post Hospital Discharge (90 Days) ]
    Plasma concentrations Cysteine (Cys) will be collected via blood draw.

  17. Plasma Concentrations of Cistine (CySS) [ Time Frame: Baseline, Post Hospital Discharge (90 Days) ]
    Plasma concentrations CySS will be collected via blood draw.

  18. 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.

  19. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03166371


Contacts
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Contact: Thomas R Ziegler, MD 4047277351 tzieg01@emory.edu

Locations
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United States, Georgia
Emory University Hospital Clinical Research Center Recruiting
Atlanta, Georgia, United States, 30322
Contact: Thomas Ziegler, MD    404-727-7351    tzieg01@emory.edu   
Sponsors and Collaborators
Emory University
Your Energy Systems, LLC
Investigators
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Principal Investigator: Thomas R Ziegler, MD Emory University

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Responsible Party: Thomas R. Ziegler, MD, Professor, Emory University
ClinicalTrials.gov Identifier: NCT03166371     History of Changes
Other Study ID Numbers: IRB00095819
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thomas R. Ziegler, MD, Emory University:
Endocrinology
Nutrition
Aging

Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders