RecruitingNot ApplicableNCT06521086

Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery

Optimizing Recovery in Trauma Patients: Integrating Enhanced Nutrition Delivery With Muscle Assessments, Functional Outcomes and Quality of Life


Sponsor

Duke University

Enrollment

60 participants

Start Date

Feb 18, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, randomized, controlled trial designed to evaluate the impact of enhanced protein supplementation compared to a standard of care nutrition delivery in critically ill older adult trauma patients. Subjects will be randomized 1:1 to either enhanced nutrition or control arm. Subjects randomized to the enhanced nutrition 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.


Eligibility

Min Age: 45 Years

Inclusion Criteria3

  • Patients who are at least 45 years old and presented to the Emergency Department as a leveled trauma
  • Patients who have the ability to tolerate oral nutrition
  • Patients who have had a standard of care CT scan this admission

Exclusion Criteria7

  • Expected withdrawal of life-sustaining treatment within 48 hours
  • Traumatic Brain Injury
  • Presence of lower extremity fracture(s)
  • Mechanical Ventilation
  • Subjects for who the Investigator would recommend a different supplement based on their medical condition.
  • Prisoner
  • Pregnancy for women of child-bearing potential

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Interventions

DIETARY_SUPPLEMENTNutrition Supplements - Fresubin KCAL Drinks

Fresubin drinks will be taken up to 3 times a day throughout hospitalization and for 4 weeks after discharge.


Locations(1)

Duke University Hospital

Durham, North Carolina, United States

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NCT06521086


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