Clinical trial NCT03166371: Glutathione (GSH) Supplementation After Hospitalization
Official title: Bioavailable Glutathione Supplementation: During Hospitalization and Beyond
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Malnutrition
Keywords: Endocrinology
Nutrition
Aging
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Your Energy Systems, LLC
First posted: 2017-05-25
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Plasma Concentrations of GSH
timeFrame: Baseline, Post Hospital Discharge (90 Days)
measure: Change in GSH/glutathione Disulfide (GSSG) Concentration Ratio
timeFrame: Baseline, Post Hospital Discharge (90 Days)
measure: Change in GSH/GSSH Pool Redox Potential (Eh)
timeFrame: Baseline, Post Hospital Discharge (90 Days)
Secondary outcomes:
measure: Body Composition assessed by Dual Energy X-ray Absorptiometry (DEXA) Scan
timeFrame: Baseline, Post Hospital Discharge (90 Days)
measure: Change in Waist Circumference
timeFrame: Baseline, Post Hospital Discharge (90 Days)
measure: Change in Hip Circumference
timeFrame: Baseline, Post Hospital Discharge (90 Days)
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline, Post Hospital Discharge (90 Days)
measure: Change in Total Body Water (TBW) Volume
timeFrame: Baseline, Post Hospital Discharge (90 Days)
measure: Change in Intracellular Water Volume assessed by Bioelectrical Impedance Analysis (BIA)
timeFrame: Baseline, Post Hospital Discharge (90 Days)
measure: Change in Extracellular Water Volume assessed by Bioelectrical Impedance Analysis (BIA)
timeFrame: Baseline, Post Hospital Discharge (90 Days)
measure: Change in Phase Angle Measurements assessed by Bioelectrical Impedance Analysis (BIA)
timeFrame: Baseline, Post Hospital Discharge (90 Days)
measure: Change in Short Physical Performance Battery Score
timeFrame: Baseline, Post Hospital Discharge (90 Days)
measure: Change in Timed Up and Go Test Score
timeFrame: Baseline, Post Hospital Discharge (90 Days)
measure: Change in Grip Strength assessed by Hand-Grip Dynamometry
timeFrame: Baseline, Post Hospital Discharge (90 Days)
measure: Change in Life Space Assessment Questionnaire Score
timeFrame: Baseline, Post Hospital Discharge (90 Days)
measure: Change in Iowa Fatigue Scale Score
timeFrame: Baseline, Post Hospital Discharge (90 Days)
measure: Change in Edmonton Frail Scale Score
timeFrame: Baseline, Post Hospital Discharge (90 Days)
measure: Change in Fatigue Symptom Inventory (FSI) Score
timeFrame: Baseline, Post Hospital Discharge (90 Days)
measure: Plasma Concentrations of Cysteine (Cys)
timeFrame: Baseline, Post Hospital Discharge (90 Days)
measure: Plasma Concentrations of Cistine (CySS)
timeFrame: Baseline, Post Hospital Discharge (90 Days)
measure: Cys/CySS Ratio
timeFrame: Baseline, Post Hospital Discharge (90 Days)
measure: Cys/CySS Pool Redox Potential
timeFrame: Baseline, Post Hospital Discharge (90 Days)
Other outcomes:
Locations:
Study officials:
affiliation: Emory University
name: Thomas R Ziegler, MD
role: PRINCIPAL_INVESTIGATOR
References: