NCT06521086 Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery
| NCT ID | NCT06521086 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Trauma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-02-18 |
| Primary Completion | 2028-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-02-18 with a primary completion date of 2028-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Paul Wischmeyer, MD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT06521086 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Trauma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06521086 currently recruiting?
Yes, NCT06521086 is actively recruiting participants. Contact the research team at paul.wischmeyer@duke.edu for enrollment information.
Where is the NCT06521086 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT06521086 clinical trial?
NCT06521086 is sponsored by Duke University. The principal investigator is Paul Wischmeyer, MD at Duke University. The trial plans to enroll 60 participants.