Recruiting

Enhanced Nutrition

Sponsor:

Duke University

Code:

NCT06521086

Conditions

Trauma

Critical Illness

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Nutrition Supplements - Fresubin KCAL Drinks

Study Details

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.

Conditions

Trauma

Critical Illness

Study ID

NCT06521086

Start date

Feb 18, 2026

Status verified date

Jun, 2026

Completion date

May 30, 2028

Anticipated

Primary completion date

May 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Nutrition Supplements - Fresubin KCAL Drinks

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Paul Wischmeyer, MD

919-681-9660paul.wischmeyer@duke.edu

Krista Haines, MD

919-681-3784krista.haines@duke.edu

Locations

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Lynnette Moats

919-681-3399lynnette.moats@duke.edu

More Information

Sponsor

Duke University

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-06-03.