N/A
N=40
Personalized Nutrition Delivery to Improve Resilience in Older Adult Trauma Patients
Trauma · Critical Illness
Bottom Line
View on ClinicalTrials.gov: NCT05544162 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jun 2026
Primary outcome: Primary: Number of Patients Recruited — 28; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nutrition supplement - Ensure shakes (Dietary_supplement)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Recruited |
28; 12 | — |
| SECONDARY Number of Study Participants Who Adhere to the SeND Home Treatment Protocol |
28 | — |
| SECONDARY Percentage of Participants Retained to Study Completion |
75; 67 | — |
| SECONDARY Time to Complete Each Outcome |
— | — |
| SECONDARY How Well Outcome Assessments Are Tolerated |
— | — |
| SECONDARY Duration of Testing Time |
— | — |
| SECONDARY Ability to Successfully Complete Testing in One Cycle Will be Recorded |
— | — |
| SECONDARY Provider Satisfaction With SeND Home |
— | — |
| SECONDARY Provider Assessment of Usefulness of SeND Home |
— | — |
| SECONDARY Number of Interventions Delivered Per Protocol in the ICU, on the Floor, and In-home |
— | — |
Summary
This is a Pilot study designed to set up for an randomized clinical trial (RCT) comparing the SeND Home pathway to a standard of care nutrition delivery in critically ill older adult trauma patients. Subjects will be randomized 3:1 to either SeND Home precision nutrition pathway or control arm. Subjects randomized to the SeND Home 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.
Eligibility Criteria
Inclusion Criteria
- Patients who are at least 60 years old and admitted to the trauma service
- Patients who have had a standard of care CT scan
Exclusion Criteria
- Expected withdrawal of life-sustaining treatment within 48 hours
- Prisoners
- Unable to provide informed consent
- Non-English speakers
- Traumatic Brain Injury
- Allergic to milk or soy ingredients (Common allergen in Ensure shakes).
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT05544162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.