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NCT Number: NCT06521086

Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Hospital

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

Krista Haines, MD

SUB_INVESTIGATOR

Lynnette Moats

CONTACT

[email protected]

919-681-3399

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in muscle mass as a measure of muscle quality

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

  2. Change in glycogen stores as a measure of muscle quality

    Time frame: 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

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

    Body composition is the percentage of a body's weight that is fat tissue.

Secondary outcomes

  1. Change in six minute walk test (6MWT) distance

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

    The 6MWT assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.

  2. Change in four meter gait speed

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

    Four meter gait speed is the time one takes to walk four meters on a level surface.

  3. Change in 30-second sit to stand test

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

    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.

  4. Change in grip strength

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

    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.

  5. Change in quadriceps strength

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Krista Haines, MD

CONTACT

[email protected]

919-681-3784

Paul Wischmeyer, MD

CONTACT

[email protected]

919-681-9660

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 25, 2024
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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