← Back to Search

Dietary Supplement

Enhanced Protein Supplementation for Critical Illness

N/A
Waitlist Available
Led By Paul Wischmeyer, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to one month post-discharge (approximately six weeks)
Awards & highlights

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.

Who is the study for?
This trial is for older adults who have experienced trauma or critical illness and are in need of nutritional support. Participants must be able to consume oral nutrition supplements and follow the study protocol both during their hospital stay and for four weeks after discharge.
What is being tested?
The study compares enhanced protein supplementation (Fresubin KCAL Drinks up to three times daily) with standard nutrition care provided by clinical providers. The goal is to see if extra protein helps improve recovery in trauma patients.
What are the potential side effects?
Potential side effects may include digestive discomfort, such as bloating, gas, or diarrhea due to the high-protein content in Fresubin KCAL Drinks. Some individuals might also experience allergic reactions or intolerance to ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to one month post-discharge (approximately six weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to one month post-discharge (approximately six weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in body composition (percentage of a body's weight that is fat tissue) as a measure of muscle quality
Change in glycogen stores as a measure of muscle quality
Change in muscle mass as a measure of muscle quality
Secondary study objectives
Change in 30-second sit to stand test
Change in four meter gait speed
Change in grip strength
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced Protein SupplementationExperimental Treatment1 Intervention
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.
Group II: Control PathwayActive Control1 Intervention
Standard of care nutrition delivery throughout hospitalization. Upon discharge participants will be sent home with standard nutrition information without Indirect Calorimetry (IC) guidance.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,408 Previous Clinical Trials
3,061,734 Total Patients Enrolled
19 Trials studying Critical Illness
10,804 Patients Enrolled for Critical Illness
Paul Wischmeyer, MDPrincipal InvestigatorDuke University
6 Previous Clinical Trials
534 Total Patients Enrolled
2 Trials studying Critical Illness
133 Patients Enrolled for Critical Illness
~40 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top