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

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ClinicalTrials.gov Identifier: NCT03904615
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : July 22, 2020
Sponsor:
Collaborator:
Dairy Management Inc.
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Study Description
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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
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03904615


Contacts
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Contact: Elena Volpi, MD, PhD 4097721977 evolpi@utmb.edu
Contact: Rachel Deer, PhD 4092669640 rrdeer@utmb.edu

Locations
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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
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Principal Investigator: Elena Volpi, MD, PhD UTMB
More Information
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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03904615    
Other Study ID Numbers: 18-0247
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: March 2020
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

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