Glutathione (GSH) Supplementation After Hospitalization

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Malnutrition

Clinical Trial Details

NCT number	NCT03166371
Study type	Interventional
Source	Emory University
Contact
Status	Withdrawn
Phase	N/A
Start date	February 2022
Completion date	February 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04448041` - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed	`NCT03268902` - Early Life Interventions for Childhood Growth and Development In Tanzania	Phase 2/Phase 3
Active, not recruiting	`NCT04746664` - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia	N/A
Completed	`NCT04608656` - Livestock for Health Project	N/A
Completed	`NCT06009198` - Nutritional, and WASH Related Education Intervention to Address Malnutrition of Early Adolescents in Pakistan	N/A
Recruiting	`NCT05417672` - Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy
Recruiting	`NCT05257980` - Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial	N/A
Completed	`NCT05015647` - Low Protein Diet in CKD Patients at Risk of Malnutrition	N/A
Completed	`NCT03628196` - A Nutrition-Focused QIP in Outpatient Clinics
Enrolling by invitation	`NCT04675229` - Extending the Validation of SCREEN to Persons Living With Dementia or in Retirement Homes
Recruiting	`NCT04627376` - Multimodal Program for Cancer Related Cachexia Prevention	N/A
Not yet recruiting	`NCT06047054` - Incidence Rate and Risk Factors of Malnutrition in ICU
Not yet recruiting	`NCT05860556` - Sustainable Eating Pattern to Limit Malnutrition in Older Adults
Not yet recruiting	`NCT04183075` - Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture	N/A
Not yet recruiting	`NCT04398836` - Preoperative Nutrition for Crohn's Disease Patients	Phase 3
Not yet recruiting	`NCT03150927` - Clinical Study of Novel Probiotic Microbial Composite™ to Treat Undernourished Young Children	N/A
Recruiting	`NCT02833740` - Comparing Performance of Simplified Mid-Upper Arm Circumference Devices ("Click-MUACs") to Detect Acute Malnutrition	N/A
Recruiting	`NCT03408067` - Evaluation of the Efficacy of Nutritional Risk Screening Tests, NRS 2002 and SGA, to Identifying Malnourished Patients	N/A
Completed	`NCT02938234` - Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Free Intake	N/A
Completed	`NCT02938247` - Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Scheduled Intake	N/A