TraumaNCT06521086
Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery
A study testing Nutrition Supplements - Fresubin KCAL Drinks in people with Trauma and Critical Illness, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Trauma, Critical Illness
- What is being tested?
- Nutrition Supplements - Fresubin KCAL Drinks
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2026to 30 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Hospital
Durham, North Carolina, 27710
Lynnette Moats, 919-681-3399, lynnette.moats@duke.edu
Krista Haines, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Trauma, Critical Illness
- Being tested
- Nutrition Supplements - Fresubin KCAL Drinks
- Medical subject headings
- Wounds and Injuries, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition Supplements - Fresubin KCAL DrinksDietary supplement
Fresubin drinks will be taken up to 3 times a day throughout hospitalization and for 4 weeks after discharge.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle mass as a measure of muscle quality
Measured: Baseline to one month post-discharge (approximately six weeks)
Change in glycogen stores as a measure of muscle quality
Measured: 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.
Measured: Baseline to one month post-discharge (approximately six weeks)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to one month post-discharge (approximately six weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start18 Feb 2026
- Primary completion30 May 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Wischmeyer, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521086
- Sponsor's protocol ID
- Pro00114950
- Status last verified
- Jun 2026
- First submitted
- 3 May 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Recovery in Trauma Patients: Integrating Enhanced Nutrition Delivery With Muscle Assessments, Functional Outcomes and Quality of Life
- ClinicalTrials.gov ID
- NCT06521086
- Acronym / sponsor ID
- Pro00114950
- Conditions
- Trauma, Critical Illness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Protein Supplementation | Experimental | Dietary Supplement: Nutrition Supplements - Fresubin KCAL DrinksOral 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. |
| 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition Supplements - Fresubin KCAL DrinksFresubin drinks will be taken up to 3 times a day throughout hospitalization and for 4 weeks after discharge. | Dietary supplement | Enhanced Protein Supplementation |
Primary outcome
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)
Body composition is the percentage of a body's weight that is fat tissue.
5 secondary outcomes
Change in six minute walk test (6MWT) distance
Time frame: Baseline to one month post-discharge (approximately six weeks)
Change in four meter gait speed
Time frame: Baseline to one month post-discharge (approximately six weeks)
Change in 30-second sit to stand test
Time frame: Baseline to one month post-discharge (approximately six weeks)
Change in grip strength
Time frame: Baseline to one month post-discharge (approximately six weeks)
Change in quadriceps strength
Time frame: Baseline to one month post-discharge (approximately six weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Wischmeyer, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Supplements - Fresubin KCAL Drinks in people with Trauma and Critical Illness, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Wischmeyer, MD (919-681-9660, paul.wischmeyer@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle mass as a measure of muscle quality (time frame: Baseline to one month post-discharge (approximately six weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.