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Optimizing Recovery in Trauma Patients with Enhanced Nutrition

This study is looking at whether giving extra nutrition to older adults (age 45 and up) who have experienced a trauma can help them recover better. You would be randomly assigned to one of two groups: either receiving Fresubin KCAL Drinks up to three times a day while in the hospital and for four weeks after discharge, or receiving standard nutrition advice. Researchers will measure changes in your muscle mass, glycogen stores (how your body stores energy), and body composition (the percentage of fat in your body) to see if the enhanced nutrition helps. To join, you need to be at least 45, have experienced a trauma, be able to eat by mouth, and have had a standard CT scan during your hospital stay. The study status is currently unclear.

Study design
This is a randomized, controlled study with a planned enrollment of 60 participants. You would be randomly assigned to one of two groups.
What's involved
You would undergo non-invasive tests measuring energy use, body composition, and muscle mass. You would also complete walking and strength tests, and surveys about quality of life at hospital admission, around day 14 or discharge, and one month after discharge.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one month after hospital discharge.

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NCT06521086

Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery

Recruiting
NAAges 45+InterventionalPrevention
Duke University
~60 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:Nutrition Supplements - Fresubin KCAL Drinks

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in muscle mass as a measure of muscle quality
Measured over Baseline to one month post-discharge (approximately six weeks)
+2 more outcomes measured

Conditions

Trauma
Critical Illness

Explore related trials

Critical IllnessInjury

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Paul Wischmeyer, MD · PRINCIPAL_INVESTIGATOR · Duke University

Who to contact

Paul Wischmeyer, MD
[email protected]
919-681-9660
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in muscle mass as a measure of muscle qualityBaseline to one month post-discharge (approximately six weeks)
  • Change in glycogen stores as a measure of muscle qualityBaseline to one month post-discharge (approximately six weeks)
  • Change in body composition (percentage of a body's weight that is fat tissue) as a measure of muscle qualityBaseline to one month post-discharge (approximately six weeks)

    Body composition is the percentage of a body's weight that is fat tissue.