Geriatric Recovery Using Inpatient and Post-hospitalization Supplementation (GRIPS)
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ClinicalTrials.gov Identifier: NCT03904615 |
Recruitment Status :
Suspended
(recruitment temporarily suspended due to difficulty sourcing supplements (supply chain problem))
First Posted : April 5, 2019
Last Update Posted : April 21, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Aging | Dietary Supplement: Whey Protein Dietary Supplement: Collagen Protein Dietary Supplement: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 160 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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Whey Protein
30 g of whey protein twice daily during hospitalization and for 30 days after discharge
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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
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Dietary Supplement: Placebo
30 g of maltodextrin in flavored water, twice daily, during hospitalization and for 30 days post-discharge |
- 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

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

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
United States, Texas | |
UTMB Acute Care for Elders Unit | |
Galveston, Texas, United States, 77550 | |
Jennie Sealy Hospital | |
Galveston, Texas, United States, 77555 |
Principal Investigator: | Elena Volpi, MD, PhD | UTMB |
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: | April 21, 2022 |
Last Verified: | April 2022 |
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 |