University of Texas Medical Branch

Geriatric Recovery Using Inpatient and Post-hospitalization Supplementation

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

Aging

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

Arm	Description	Assigned 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

Erin Hommel, MD
4092669669
erhommel@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.