Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery (NCT06521086) | Clinical Trial Compass
RecruitingNot Applicable
Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery
United States60 participantsStarted 2026-02-18
Plain-language 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.
Who can participate
Age range
45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in muscle mass as a measure of muscle quality
Timeframe: Baseline to one month post-discharge (approximately six weeks)
2
Change in glycogen stores as a measure of muscle quality
Timeframe: Baseline to one month post-discharge (approximately six weeks)
3
Change in body composition (percentage of a body's weight that is fat tissue) as a measure of muscle quality
Timeframe: Baseline to one month post-discharge (approximately six weeks)