Geriatric Recovery Using Inpatient and Post-hospitalization Supplementation

Phase 1

Completed

• Conditions: Aging
• Interventions: Dietary Supplement: Collagen Protein; Dietary Supplement: Whey Protein; Dietary Supplement: Placebo

• Registration Number: NCT03904615
• Lead Sponsor: The University of Texas Medical Branch, Galveston

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 Timeline

• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2019-04-04
• Study First Posted: 2019-04-05
• Study Start: 2019-06-19
• Primary Completion: 2024-03-18
• Study Completion: 2024-10-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collagen Protein	Collagen Protein	30 g of collagen protein twice daily during hospitalization and for 30 days after discharge
Whey Protein	Whey Protein	30 g of whey protein twice daily during hospitalization and for 30 days after discharge
Placebo	Placebo	30 g of maltodextrin twice daily during hospitalization and for 30 days after discharge

Primary Outcome Measures

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

Trial Locations

Locations (2)

UTMB Acute Care for Elders Unit; 🇺🇸 Galveston, Texas, United States

Jennie Sealy Hospital; 🇺🇸 Galveston, Texas, United States