CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled / 40 target
Drug / intervention
Nutrition supplement - Ensure shakesdietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05544162
NCT05544162N/ACompletedOn Track (1.0/mo)Completion was 28mo ago

Personalized Targeted Nutrition Via StructurEd Nutrition Delivery Pathway to Improve Resilience in Older Adult Trauma Patients

Duke University·interventional·Posted Sep 16, 2022·Updated Jun 2, 2026

In Brief

A clinical study evaluating Nutrition supplement - Ensure shakes for Trauma and Critical Illness. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedSep 16, 2022
Enrollment StartJan 5, 2023
Primary CompletionFeb 1, 2024
Study CompletionJul 26, 2024
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 3.8 years ago

Arms & Interventions

SeND Home precision nutrition pathwayexperimental

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 by the clinical dietitian.

Dietary Supplement: Nutrition supplement - Ensure shakes
Control pathwayno_intervention

Standard of care nutrition delivery throughout hospitalization. Upon discharge they will be sent home with standard nutrition information without Indirect Calorimetry (IC) guidance.

Interventions

Nutrition supplement - Ensure shakesdietary

Ensure shakes will be take up to 3 times a day throughout hospitalization and for 4 weeks after discharge.