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

• ClinicalTrials.gov Identifier: NCT03904615
• Recruitment Status: Recruiting
• First Posted: April 5, 2019
• Last Update Posted: December 20, 2019
• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborator: Dairy Management Inc.
• Information provided by (Responsible Party): The University of Texas Medical Branch, Galveston

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Aging	Dietary Supplement: Whey Protein; Dietary Supplement: Collagen Protein; Dietary Supplement: Placebo	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel randomized double blind phase 1 trial of 3 interventions
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• 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
• Actual Study Start Date: June 19, 2019
• Estimated Primary Completion Date: March 31, 2023
• Estimated Study Completion Date: March 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Elena Volpi, MD, PhD; 4097721977; evolpi@utmb.edu

Contact: Rachel Deer, PhD; 4092669640; rrdeer@utmb.edu

Locations

United States, Texas

UTMB Acute Care for Elders Unit; Recruiting

Galveston, Texas, United States, 77550

Contact: Rachel Deer, PhD rrdeer@utmb.edu

Principal Investigator: Elena Volpi, MD, PhD

Jennie Sealy Hospital; Not yet recruiting

Galveston, Texas, United States, 77555

Contact: Rachel R Deer, PhD

Contact: Roxana M Hirst, MS 4092669641 rmhirst@utmb.edu

Sponsors and Collaborators

The University of Texas Medical Branch, Galveston

Dairy Management Inc.

Investigators

• Principal Investigator: Elena Volpi, MD, PhD; UTMB

More Information

• Responsible Party: The University of Texas Medical Branch, Galveston
• ClinicalTrials.gov Identifier: NCT03904615
• Other Study ID Numbers: 18-0247
• First Posted: April 5, 2019
• Last Update Posted: December 20, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No. This is a small Phase 1 feasibility pilot study. Risk of loss of confidentiality

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No