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Dietary Supplement

Nutrition Supplements for Trauma Recovery in Older Adults (SeND Home Trial)

N/A
Waitlist Available
Led By Krista Haines, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if giving older trauma patients extra nutrition shakes helps them recover better. The patients will get these shakes in the hospital and for some time after leaving. Researchers will check their energy use, body composition, muscle mass, and overall quality of life.

Who is the study for?
This trial is for trauma patients who are at least 60 years old and admitted to the trauma service, with a standard care CT scan done. It's not for non-English speakers, pregnant individuals, prisoners, those expected to withdraw from life-sustaining treatment within 48 hours, anyone unable to consent or allergic to milk/soy.
What is being tested?
The study compares SeND Home precision nutrition pathway (Ensure shakes up to three times daily in hospital and four weeks post-discharge) against normal nutrition recommendations by clinical providers. Participants will be randomly assigned in a ratio of 3:1 favoring the SeND Home group.
What are the potential side effects?
Potential side effects may include reactions related to milk or soy allergies due to ingredients in Ensure shakes. Other general risks could involve discomfort from non-invasive tests measuring energy use, body composition, and muscle mass.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of SeND Home pathway
Secondary study objectives
Acceptability of SeND Home pathway
Fidelity of SeND Home pathway

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SeND Home precision nutrition pathwayExperimental 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 by the clinical dietitian.
Group II: Control pathwayActive Control1 Intervention
Standard of care nutrition delivery throughout hospitalization. Upon discharge they will be sent home with standard nutrition information without Indirect Calorimetry (IC) guidance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nutrition supplement - Ensure shakes
2023
N/A
~40

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,455 Previous Clinical Trials
2,971,039 Total Patients Enrolled
Krista Haines, MDPrincipal InvestigatorDuke University

Media Library

Ensure shakes (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05544162 — N/A
Difficult Weaning Research Study Groups: SeND Home precision nutrition pathway, Control pathway
Difficult Weaning Clinical Trial 2023: Ensure shakes Highlights & Side Effects. Trial Name: NCT05544162 — N/A
Ensure shakes (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05544162 — N/A
~14 spots leftby Dec 2025
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