← Back to Search

Dietary Supplement

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

N/A

Recruiting

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

SeND Home Trial Summary

This trial will compare nutrition delivery in critically ill older adults to help figure out the best approach.

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.Check my eligibility

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.See study design

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.

SeND Home Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of SeND Home pathway

Secondary outcome measures

Acceptability of SeND Home pathway

Fidelity of SeND Home pathway

SeND Home 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,363 Previous Clinical Trials

3,420,466 Total Patients Enrolled

18 Trials studying Critical Illness

10,764 Patients Enrolled for Critical Illness

Krista Haines, MDPrincipal InvestigatorDuke University

Media Library

Ensure shakes (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05544162 — N/A

Critical Illness Research Study Groups: SeND Home precision nutrition pathway, Control pathway

Critical Illness 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any openings presently available for individuals to join this study?

"Based on the current information hosted on clinicaltrials.gov, this trial is no longer accepting new participants; it was initially posted on February 1st 2023 and last updated in January 24th 2023. Nevertheless, there are still 918 other active studies currently recruiting patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Personalized Nutrition Delivery to Improve Resilience in Older Adult Trauma Patients

2023. "Personalized Nutrition Delivery to Improve Resilience in Older Adult Trauma Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05544162.