Glutathione (GSH) Supplementation After Hospitalization

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.

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