Purpose

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.

Condition

Eligibility

Eligible Ages
Over 65 Years
Eligible Genders
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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Parallel randomized double blind phase 1 trial of 3 interventions
Primary Purpose
Supportive Care
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Whey Protein
30 g of whey protein twice daily during hospitalization and for 30 days after discharge
  • Dietary Supplement: Whey Protein
    30 g of whey protein in flavored water, twice daily, during hospitalization and for 30 days post-discharge
Active Comparator
Collagen Protein
30 g of collagen protein twice daily during hospitalization and for 30 days after discharge
  • Dietary Supplement: Collagen Protein
    30 g of collagen protein in flavored water, twice daily, during hospitalization and for 30 days post-discharge
Placebo Comparator
Placebo
30 g of maltodextrin twice daily during hospitalization and for 30 days after discharge
  • Dietary Supplement: Placebo
    30 g of maltodextrin in flavored water, twice daily, during hospitalization and for 30 days post-discharge

Recruiting Locations

UTMB Acute Care for Elders Unit
Galveston, Texas 77550
Contact:
Erin Hommel, MD
erhommel@utmb.edu

Jennie Sealy Hospital
Galveston, Texas 77555
Contact:
Erin R Hommel, MD
erhommel@utmb.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Elena Volpi, MD, PhD
4097721977
evolpi@utmb.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.