Aging
Conditions
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.
Interventions
DIETARY_SUPPLEMENTWhey Protein
30 g of whey protein in flavored water, twice daily, during hospitalization and for 30 days post-discharge
DIETARY_SUPPLEMENTCollagen Protein
30 g of collagen protein in flavored water, twice daily, during hospitalization and for 30 days post-discharge
DIETARY_SUPPLEMENTPlacebo
30 g of maltodextrin in flavored water, twice daily, during hospitalization and for 30 days post-discharge
Sponsors
Dairy Management Inc.
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel randomized double blind phase 1 trial of 3 interventions
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Function | Change from baseline to 30 days after discharge | Short Physical Performance Battery (SPPB) scale, 0-12 points. 0=disabled; 12=high performance |
Countries
United States
Outcome results
None listed