Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery

Optimizing Recovery in Trauma Patients: Integrating Enhanced Nutrition Delivery With Muscle Assessments, Functional Outcomes and Quality of Life

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Trauma
• Intervention / Treatment: Dietary supplement: Nutrition Supplements - Fresubin KCAL Drinks

Detailed Description

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. Enhanced protein supplementation supports patients from ICU admission to 4-weeks post-hospital discharge, providing a comprehensive and personalized plan of care carried to completion.

Subjects will be randomized 1:1 to enhanced nutrition or control arm. Subjects randomized enhanced nutrition oral nutrition supplements (Fresenius KCAL shakes) 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. They will also be asked to complete walking and strength tests, and surveys about quality of life.These will be done at hospital admission, day 14 or hospital discharge, and at a one month post-discharge follow-up visit.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Krista Haines, MD; Phone Number: 919-681-3784; Email: krista.haines@duke.edu
• Study Contact Backup: Name: Paul Wischmeyer, MD; Phone Number: 919-681-9660; Email: paul.wischmeyer@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Hospital
      • Contact: Lynnette Moats; Phone Number: 919-681-3399; Email: lynnette.moats@duke.edu
      • Sub-Investigator: Krista Haines, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Dietary supplement: Nutrition Supplements - Fresubin KCAL Drinks; Fresubin drinks will be taken up to 3 times a day throughout hospitalization and for 4 weeks after discharge.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in muscle mass as a measure of muscle quality		Baseline to one month post-discharge (approximately six weeks)
Change in glycogen stores as a measure of muscle quality		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	Body composition is the percentage of a body's weight that is fat tissue.	Baseline to one month post-discharge (approximately six weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in six minute walk test (6MWT) distance	The 6MWT assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.	Baseline to one month post-discharge (approximately six weeks)
Change in four meter gait speed	Four meter gait speed is the time one takes to walk four meters on a level surface.	Baseline to one month post-discharge (approximately six weeks)
Change in 30-second sit to stand test	This test measures the number of times an individual can stand from a chair with no assistance in 30 seconds. This test is used to assess functional lower body strength.	Baseline to one month post-discharge (approximately six weeks)
Change in grip strength	Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength.	Baseline to one month post-discharge (approximately six weeks)
Change in quadriceps strength	ED (electromechanical dynamometry) can be used in either isometric or isokinetic mode. Quadriceps strength is expressed as peak knee extensor torque, which is produced at around 60° knee flexion.	Baseline to one month post-discharge (approximately six weeks)

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Paul Wischmeyer, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2028

Study Registration Dates

• First Submitted: May 3, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness; Wounds and Injuries
• Other Study ID Numbers: Pro00114950

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No