Nutritional Shake for Postoperative Recovery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a nutritional shake can aid older patients in recovering better after surgery. The shake, rich in essential nutrients, is administered to assess its impact on physical and mental recovery compared to standard dietary advice. Patients aged 70 or older, undergoing major orthopedic or abdominal surgery, and without major food allergies or certain medical conditions, may qualify. Participants will receive either the shake or dietary guidance, and researchers will monitor their recovery in the hospital and for 90 days afterward. As an unphased trial, this study provides a unique opportunity to contribute to research that could improve recovery for future patients.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this nutritional shake is safe for postoperative recovery?
Research shows that nutritional shakes, like the one under testing, are usually easy for people to handle. A study on similar shakes found no serious side effects and a low risk when using whey protein, a common ingredient. These shakes often support the immune system and aid recovery after surgery. No major safety concerns exist with this type of shake, especially when used under a doctor's guidance.12345
Why are researchers excited about this trial?
Researchers are excited about this nutritional shake for postoperative recovery because it offers a unique approach by directly addressing nutritional needs right after surgery. Unlike standard recovery protocols that focus mainly on dietary advice, this treatment provides a ready-to-consume shake that can be tailored as a supplement or meal replacement, depending on the patient's weight. This personalized approach optimizes recovery by ensuring patients receive essential nutrients in a convenient, easy-to-track format, potentially leading to faster and more effective healing.
What evidence suggests that this nutritional shake is effective for postoperative recovery?
Research shows that nutritional supplements can aid recovery after surgery. Studies have found that these supplements improve nutrition, enhancing overall recovery. Early nutritional support has been linked to shorter hospital stays without increasing costs. Malnutrition can hinder recovery, but supplements can improve outcomes and reduce complications. In this trial, one group will receive a nutritional shake designed to address common nutrient deficiencies, which shows promise for helping older patients recover physically and mentally. Another group will receive only nutrition instructions without the shake.26789
Who Is on the Research Team?
Stacie G Deiner, MD
Principal Investigator
Dartmouth-Hitchcock Medical Center
Are You a Good Fit for This Trial?
This trial is for patients aged 70 or older who are undergoing major orthopedic or abdominal surgery with a planned hospital stay of at least one night. It aims to help those at risk of malnutrition improve their physical and cognitive recovery post-surgery.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Initial Recovery
Participants undergo elective major abdominal and orthopedic surgery and initial recovery in the hospital
Treatment
Participants receive a daily nutritional shake for 30 days after hospital discharge
Follow-up
Participants are monitored for changes in disability and cognitive function scores, and feasibility of MRI scans is assessed
What Are the Treatments Tested in This Trial?
Interventions
- Nutritional Shake
Trial Overview
The study tests a specially formulated nutritional shake against standard postoperative nutritional instructions. The goal is to see if the shake can enhance physical function and brain recovery in frail, older surgical patients.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dartmouth-Hitchcock Medical Center
Lead Sponsor
Hitchcock Foundation
Collaborator
Citations
Benefits of post-operative oral protein supplementation in ...
Previous reviews have concluded that oral nutritional supplements can have positive effects in terms of recovery of nutritional status post-operatively in ...
NCT07109505 | Nutrition to Support Postoperative Recovery
The outcome will compare patients receiving a 30-day supply of daily nutritional shake and general healthy nutrition recommendations versus those only ...
Postoperative Dietary Intake Achievement: A Secondary ...
The postoperative patients, who rapidly progressed to standard diet immediately after 500 mL clear fluid toleration, achieved higher energy ...
Association between early postoperative nutritional ...
Early nutritional supplementation was associated with a significantly shorter hospital stay without an increase in costs.
Malnutrition is linked to worse postoperative outcomes ...
Malnutrition is linked to worse postoperative outcomes, including increased hospital stay, sepsis, and mortality. Perioperative supplementation ...
Ensure® Surgery
Immunonutrition shake. ENSURE SURGERY is specially designed to support immune health and recovery from surgery. For oral use. Use under medical supervision.
SAFETY DATA SHEET
Exposure Limits: This material is a particulate matter and adequate inhalation/respiratory protection should be used to minimize exposure. No ...
Impact of Enhanced Recovery after Surgery with Preoperative ...
Adverse Events and Data Safety Monitoring. There were no serious side effects identified and low anesthetic risk of drinking whey protein three ...
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nutritioncare.org
nutritioncare.org/wp-content/uploads/2024/12/Nutrition-Intervention-in-ERAS-Pathway.pdfNutrition Intervention in Enhanced Recovery After Surgery ...
Patients who are screened at nutritional risk should receive preoperative oral nutrition supplements for at least 7 days using either IMN formulas (containing ...
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