Personalized Nutrition Delivery to Improve Resilience in Older Adult Trauma Patients

Completed · Not applicable

Conditions studied: Trauma, Critical Illness

In brief

This is a Pilot study designed to set up for an randomized clinical trial (RCT) comparing the SeND Home pathway to a standard of care nutrition delivery in critically ill older adult trauma patients. Subjects will be randomized 3:1 to either SeND Home precision nutrition pathway or control arm. Subjects randomized to the SeND Home arm will receive oral nutrition supplements (ONS) up to 3 times per day while in the hospital and for 4 weeks after discharge. Subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass.

Key facts

Study ID

NCT05544162

Run by

Duke University

People needed

40

Starts

2023-01-05

Expected to finish

2024-07-26

Last updated by the study team

2026-06-02

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who are at least 60 years old and admitted to the trauma service
• Patients who have had a standard of care CT scan

You may not qualify if…

• Expected withdrawal of life-sustaining treatment within 48 hours
• Prisoners
• Unable to provide informed consent
• Non-English speakers
• Traumatic Brain Injury
• Allergic to milk or soy ingredients (Common allergen in Ensure shakes).
• Pregnancy

Where it is running

• Duke University Hospital — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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