Geriatric Recovery Using Inpatient and Post-hospitalization Supplementation (GRIPS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aging
• Intervention / Treatment: Dietary supplement: Whey Protein; Dietary supplement: Collagen Protein; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Erin Hommel, MD; Phone Number: 4092669669; Email: erhommel@utmb.edu
• Study Contact Backup: Name: Shawn Goodlett; Phone Number: 4092667590; Email: smgoodle@utmb.edu

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77550
      • Recruiting
      • UTMB Acute Care for Elders Unit
      • Principal Investigator: Elena Volpi, MD, PhD
      • Contact: Erin Hommel, MD; Email: erhommel@utmb.edu
    • Galveston, Texas, United States, 77555
      • Recruiting
      • Jennie Sealy Hospital
      • Contact: Erin R Hommel, MD; Email: erhommel@utmb.edu
      • Contact: Roxana M Hirst, MS; Phone Number: 4092669641; Email: rmhirst@utmb.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: Dairy Management Inc.
• Investigators: Principal Investigator: Elena Volpi, MD, PhD, UTMB

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2019
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 4, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 18-0247

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No. This is a small Phase 1 feasibility pilot study. Risk of loss of confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No