Geriatric Recovery Using Inpatient and Post-hospitalization Supplementation

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.

Official Title
-----------------
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

Conditions
-----------------
Aging

Intervention / Treatment
-----------------
* Dietary Supplement: Whey Protein
* Dietary Supplement: Collagen Protein
* Dietary Supplement: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel randomized double blind phase 1 trial of 3 interventions
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Whey Protein<br>30 g of whey protein twice daily during hospitalization and for 30 days after discharge | Dietary Supplement: Whey Protein<br>* 30 g of whey protein in flavored water, twice daily, during hospitalization and for 30 days post-discharge<br>|
| Active Comparator: Collagen Protein<br>30 g of collagen protein twice daily during hospitalization and for 30 days after discharge | Dietary Supplement: Collagen Protein<br>* 30 g of collagen protein in flavored water, twice daily, during hospitalization and for 30 days post-discharge<br>|
| Placebo Comparator: Placebo<br>30 g of maltodextrin twice daily during hospitalization and for 30 days after discharge | Dietary Supplement: Placebo<br>* 30 g of maltodextrin in flavored water, twice daily, during hospitalization and for 30 days post-discharge<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Function | Short Physical Performance Battery (SPPB) scale, 0-12 points. 0=disabled; 12=high performance | Change from baseline to 30 days after discharge |