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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 116
- Locations
- 2
- Primary Endpoint
- Physical Function
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Collagen Protein
30 g of collagen protein twice daily during hospitalization and for 30 days after discharge
Intervention: Collagen Protein (Dietary Supplement)
Placebo
30 g of maltodextrin twice daily during hospitalization and for 30 days after discharge
Intervention: Placebo (Dietary Supplement)
Whey Protein
30 g of whey protein twice daily during hospitalization and for 30 days after discharge
Intervention: Whey Protein (Dietary Supplement)
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
Secondary Outcomes
No secondary outcomes reported