Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery

NCT06521086 | Not Yet Recruiting

• 1 other identifier: Pro00114950
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Change in six minute walk test (6MWT) distance

  Baseline to one month post-discharge (approximately six weeks)

• Change in four meter gait speed

  Baseline to one month post-discharge (approximately six weeks)

• Change in 30-second sit to stand test

  Baseline to one month post-discharge (approximately six weeks)

• Change in grip strength

  Baseline to one month post-discharge (approximately six weeks)

• Change in quadriceps strength

  Baseline to one month post-discharge (approximately six weeks)

Study Arms (2)

Enhanced Protein Supplementation

EXPERIMENTAL

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

Control Pathway

NO INTERVENTION

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 DIETARY_SUPPLEMENT

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

Enhanced Protein Supplementation

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Wischmeyer, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Wischmeyer, MD

CONTACT

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

Krista Haines, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: July 25, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)