Geriatric Recovery Using Inpatient and Post-hospitalization Supplementation

Aging Clinical Trial

— GRIPS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03904615
• Other study ID #: 18-0247
• Status: Recruiting
• Phase: Phase 1
• Start date: June 19, 2019
• Est. completion date: March 31, 2025

Study information

• Verified date: July 2023
• Source: The University of Texas Medical Branch, Galveston
• Contact: Erin Hommel, MD
• Phone: 4092669669
• Email: erhommel[@]utmb.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

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

Locations

Country	Name	City	State
United States	Jennie Sealy Hospital	Galveston	Texas
United States	UTMB Acute Care for Elders Unit	Galveston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	Dairy Management Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Function	Short Physical Performance Battery (SPPB) scale, 0-12 points. 0=disabled; 12=high performance	Change from baseline to 30 days after discharge