Bioavailable Glutathione Supplementation: During Hospitalization and Beyond
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in GSH/glutathione Disulfide (GSSG) Concentration Ratio
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in GSH/glutathione Disulfide (GSSG) Concentration Ratio
时间窗: Baseline, Post Hospital Discharge (90 Days)
GSH concentrations will be compared to glutathione disulfide. Concentrations will be collected and analyzed via blood draw.
Change in Plasma Concentrations of GSH
时间窗: Baseline, Post Hospital Discharge (90 Days)
Plasma concentrations of GSH will be collected via blood draw.
Change in GSH/GSSH Pool Redox Potential (Eh)
时间窗: 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
次要结局
- 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 Timed Up and Go Test Score(Baseline, Post Hospital Discharge (90 Days))
- Change in Total Body Water (TBW) Volume(Baseline, Post Hospital Discharge (90 Days))
- Plasma Concentrations of Cistine (CySS)(Baseline, Post Hospital Discharge (90 Days))
- Change in Intracellular Water Volume assessed by Bioelectrical Impedance Analysis (BIA)(Baseline, Post Hospital Discharge (90 Days))
- Change in Short Physical Performance Battery Score(Baseline, Post Hospital Discharge (90 Days))
- Change in Phase Angle Measurements assessed by Bioelectrical Impedance Analysis (BIA)(Baseline, Post Hospital Discharge (90 Days))
- Change in Grip Strength assessed by Hand-Grip Dynamometry(Baseline, Post Hospital Discharge (90 Days))
- Change in Iowa Fatigue Scale Score(Baseline, Post Hospital Discharge (90 Days))
- Cys/CySS Pool Redox Potential(Baseline, Post Hospital Discharge (90 Days))
- Change in Extracellular Water Volume assessed by Bioelectrical Impedance Analysis (BIA)(Baseline, Post Hospital Discharge (90 Days))
- Change in Life Space Assessment Questionnaire Score(Baseline, Post Hospital Discharge (90 Days))
- Plasma Concentrations of Cysteine (Cys)(Baseline, Post Hospital Discharge (90 Days))
- Cys/CySS Ratio(Baseline, Post Hospital Discharge (90 Days))
- Change in Edmonton Frail Scale Score(Baseline, Post Hospital Discharge (90 Days))
- Change in Fatigue Symptom Inventory (FSI) Score(Baseline, Post Hospital Discharge (90 Days))
研究者
Thomas R. Ziegler, MD
Professor
Emory University