Geriatric Recovery Using Inpatient and Post-hospitalization Supplementation

NCT ID: NCT03904615

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-19

Study Completion Date

2024-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel randomized double blind phase 1 trial of 3 interventions
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Whey Protein

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

Group Type ACTIVE_COMPARATOR

Whey Protein

Intervention Type DIETARY_SUPPLEMENT

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

Collagen Protein

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

Group Type ACTIVE_COMPARATOR

Collagen Protein

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Whey Protein

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

Intervention Type DIETARY_SUPPLEMENT

Collagen Protein

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dairy Management Inc.

INDUSTRY

Sponsor Role collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elena Volpi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UTMB

Locations

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UTMB Acute Care for Elders Unit

Galveston, Texas, United States

Site Status

Jennie Sealy Hospital

Galveston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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18-0247

Identifier Type: -

Identifier Source: org_study_id