ClinicalTrials.gg
Sign In
CompletedNCT03904615GRIPSUpdated Dec 19, 2024

Geriatric Recovery Using Inpatient and Post-hospitalization Supplementation

A Phase 1 interventional study of Whey Protein and Collagen Protein in Aging, sponsored by The University of Texas Medical Branch, Galveston. Completed at 2 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-12-19.

Sponsored by The University of Texas Medical Branch, Galveston · Phase 1, Interventional, and Supportive care

Phase
Phase 1
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Aging
03

In context

Lead sponsor

The University of Texas Medical Branch, Galveston is the lead sponsor of 256 studies on the registry; 39 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.

Browse The University of Texas Medical Branch, Galveston studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 65 years or older.
  • Admitted to UTMB hospital for any acute medical condition
  • English speaking

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
116 participants (actual)

Study arms

  • Active comparator
    Whey Protein

    30 g of whey protein twice daily during hospitalization and for 30 days after discharge

    Dietary Supplement: Whey Protein

  • Active comparator
    Collagen Protein

    30 g of collagen protein twice daily during hospitalization and for 30 days after discharge

    Dietary Supplement: Collagen Protein

  • Placebo comparator
    Placebo

    30 g of maltodextrin twice daily during hospitalization and for 30 days after discharge

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementWhey Protein

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

  • Dietary supplementCollagen Protein

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

  • Dietary supplementPlacebo

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

06

What researchers measure

Primary outcomes

  1. Physical Function

    Short Physical Performance Battery (SPPB) scale, 0-12 points. 0=disabled; 12=high performance

    Time frame: Change from baseline to 30 days after discharge

07

Study locations

2 sites
  • UTMB Acute Care for Elders Unit
    Galveston, Texas 77550, United States
  • Jennie Sealy Hospital
    Galveston, Texas 77555, United States
08

References and documents

Individual participant data

Plan to share: No — No. This is a small Phase 1 feasibility pilot study. Risk of loss of confidentiality

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2019 to primary completion in Mar 2024, 56 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 4, 2019
First posted
Apr 5, 2019
StartActual
Jun 19, 2019
Primary completionActual
Mar 18, 2024
CompletionActual
Oct 31, 2024
Last update
Dec 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03904615
Lead sponsor
The University of Texas Medical Branch, Galveston
Collaborators
Dairy Management Inc.
Responsible party
Sponsor
First posted
Apr 5, 2019
Start date
Jun 19, 2019
Primary completion
Mar 18, 2024
Completion
Oct 31, 2024
Last update
Dec 19, 2024

Study contacts

Elena Volpi, MD, PhD
principal investigator · UTMB

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Whey Proteins

Other studies from this sponsor

The University of Texas Medical Branch, Galveston →

Start the discussion