Glutathione (GSH) Supplementation After Hospitalization

NCT03166371 | Withdrawn

• 1 other identifier: IRB00095819
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malnutrition

Keywords

Endocrinology; Nutrition; Aging

Outcome Measures

Primary Outcomes (3)

• Change in Plasma Concentrations of GSH

  Plasma concentrations of GSH will be collected via blood draw.

  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.

  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

  Baseline, Post Hospital Discharge (90 Days)

Secondary Outcomes (19)

• Body Composition assessed by Dual Energy X-ray Absorptiometry (DEXA) Scan

  Baseline, Post Hospital Discharge (90 Days)

• Change in Waist Circumference

  Baseline, Post Hospital Discharge (90 Days)

• Change in Hip Circumference

  Baseline, Post Hospital Discharge (90 Days)

• Change in Body Mass Index (BMI)

  Baseline, Post Hospital Discharge (90 Days)

• Change in Total Body Water (TBW) Volume

  Baseline, Post Hospital Discharge (90 Days)

Study Arms (2)

Liposomal Glutathione (GSH)

EXPERIMENTAL

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)

Placebo

PLACEBO COMPARATOR

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

Interventions

Liposomal Glutathione (GSH) DIETARY_SUPPLEMENT

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®

Liposomal Glutathione (GSH)

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Your Energy Systems, LLC: collaborator

MeSH Terms

Conditions

Malnutrition

Interventions

Glutathione

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Thomas R Ziegler, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 25, 2017
• Study Start: February 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: January 25, 2022

Record last verified: 2022-01