A Phase I Randomized Clinical Trial of In-hospital and Post-hospital Whey Protein vs. Low Quality Protein vs. Isocaloric Placebo Supplementation to Improve Recovery From Hospitalization in Older Adults
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Aging
- Sponsor
- The University of Texas Medical Branch, Galveston
- Enrollment
- 116
- Locations
- 2
- Primary Endpoint
- Physical Function
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of the study is to determine the feasibility of nutritional interventions designed to help older patients maintain physical function after being in the hospital. We will test the feasibility and effect of nutritional interventions with whey protein, collagen or placebo on functional recovery from hospitalization in community dwelling older adults.
Detailed Description
We will compare in a randomized parallel design double blind pilot phase I study the feasibility of whey protein vs. collagen vs. isocaloric placebo supplementation in older adults during an acute hospitalization for a medical condition, and the treatments' effect size on physical function after hospital discharge.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 65 years or older.
- •Admitted to UTMB hospital for any acute medical condition
- •English speaking
Exclusion Criteria
- •Inability to consent
- •Bed or wheelchair bound prior to hospitalization
- •Estimated creatinine clearance 20 ml/min or less, or end stage renal disease not on dialysis
- •AST/ALT 2.5 times above the normal limit
- •Active cancer
- •Palliative care/Hospice
- •Estimated protein intake \>1.2 g/kg/day during the previous 24 hours
- •Any other condition or event considered exclusionary by the PI and faculty physician
Outcomes
Primary Outcomes
Physical Function
Time Frame: Change from baseline to 30 days after discharge
Short Physical Performance Battery (SPPB) scale, 0-12 points. 0=disabled; 12=high performance