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

The University of Texas System (UT)

Status and phase: Completed; Phase 1

Conditions: Aging

Treatments: Dietary Supplement: Collagen Protein; Dietary Supplement: Placebo; Dietary Supplement: Whey Protein

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03904615

18-0247

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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116 participants in 3 patient groups, including a placebo group

Whey Protein

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Whey Protein

Collagen Protein

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Collagen Protein

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo