Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06521086
Status
Recruiting
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Conditions

  • Critical Illness
  • Trauma

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nutrition Supplements - Fresubin KCAL Drinks — DIETARY_SUPPLEMENT
    Fresubin drinks will be taken up to 3 times a day throughout hospitalization and for 4 weeks after discharge.

Study Details

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.

Key Dates

Start date
Feb 18, 2026
Status verified
Jun 2026
Primary completion
May 30, 2028
Completion
May 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Enhanced Protein Supplementation
    Oral nutrition supplements (ONS) will be given, at maximum, three times per day throughout hospitalization. Upon discharge, participants will be given 4-weeks' worth of oral supplements to take. Adjustments may be made based on indirect calorimetry (IC) measurements.
  • No Intervention: Control Pathway
    Standard of care nutrition delivery throughout hospitalization. Upon discharge participants will be sent home with standard nutrition information without Indirect Calorimetry (IC) guidance.

Primary Outcome Measure

Change in muscle mass as a measure of muscle quality [ Time Frame: Baseline to one month post-discharge (approximately six weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University HospitalDurhamNorth Carolina27710
Lynnette Moats
[email protected]
919-681-3399
Krista Haines, MD (SUB_INVESTIGATOR)

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By research site
Duke University Hospital· Durham, NC

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