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Completed

NCT Number: NCT03904615

Geriatric Recovery Using Inpatient and Post-hospitalization Supplementation

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.

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Key information

Conditions

Aging

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jennie Sealy Hospital, Galveston, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whey Protein

Dietary Supplement

30 g of whey protein in flavored water, twice daily, during hospitalization and for 30 days post-discharge

Collagen protein

Dietary Supplement

30 g of collagen protein in flavored water, twice daily, during hospitalization and for 30 days post-discharge

Placebo

Dietary Supplement

30 g of maltodextrin in flavored water, twice daily, during hospitalization and for 30 days post-discharge

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Collaborators

  • Dairy Management Inc.

Registry information

Official study 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

Acronym: GRIPS

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Apr 5, 2019
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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