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Comparison of Clinical and Patient Centered Outcomes: Postoperative Multi-nutrient Meal Plus Enhanced Recovery vs. Enhanced Recovery Alone

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Older surgical patients commonly have malnutrition, and there is evidence these patients have increased risk for poor physical and brain recovery after surgery and anesthesia. There are scientific-based recommendations to provide nutritional supplements to support recovery. However, to date these recommendations do not address a broad group of nutrients likely to reverse common deficiencies. Team members have created a palatable, broad-spectrum and stable nutritional shake that we will give to patients after surgery. We propose to test the nutritional shake in frail older surgical patients at Dartmouth Health to determine if a nutrition shake provided after surgery improves recovery of physical function and cognitive abilities. Half the patients will receive the shake and the other will receive the standard of care postoperative nutritional instructions after surgery. We will collect information regarding physical function and cognitive abilities of all the patients while in the hospital and 90 days after surgery. We will use this data to apply for funding for a powered randomized trial to determine the role of nutrition in optimizing physical and cognitive recovery from surgery in older patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 70
Healthy Volunteers: t
View:

• patients \>=70 years old having major orthopedic or abdominal surgery, defined as a procedure with a planned inpatient stay of at least one night.

Locations
United States
New Hampshire
Dartmouth-Hitchcock Medical Center
RECRUITING
Lebanon
Contact Information
Primary
Stacie G Deiner, MD
Stacie.G.Deiner@hitchcock.org
(603) 650-5922
Backup
Alexander R Roth, BA
Alexander.R.Roth@hitchcock.org
(603) 650-0397
Time Frame
Start Date: 2025-12-10
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 100
Treatments
Experimental: Shake and instructions
For the intervention arm, an unblinded study team member will deliver and review the Nutrition After Surgery and postoperative supplementation instructions with the participant.~Additionally, an unblinded study team member will give each participant a 30-day supply of single-servings. They will be instructed to consume 1 packet per day for 30 days, reconstituted per instructions (see instructions file), after discharge from the hospital. The unblinded researchers will work with the coordinator team to provide participants with a plan for supplementation (normal or underweight participants) or meal replacement (overweight or obese patients). Participants will be instructed to keep track of their shake consumption on a daily basis. Shake consumption logs will be collected via REDCap surveys sent to participants and reviewed by the unblinded coordinators/investigators for adverse events and compliance.
Other: Nutrition Instructions Only
The control arm receives the Nutrition After Surgery instructions, which provide guidelines for healthy eating after surgery but not the nutritional shake. The intervention arm receives the same instructions along with the nutrition shake mix and accompanying postoperative supplementation
Related Therapeutic Areas
Sponsors
Collaborators: Hitchcock Foundation
Leads: Dartmouth-Hitchcock Medical Center

This content was sourced from clinicaltrials.gov