Post-surgery nutrition shake to help recovery in older adults

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

We will try a daily nutritional shake after surgery to see if it helps people 70 and older recover their strength and thinking compared with standard postoperative nutrition instructions.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 70 Years and up
• Sex: All
• Sponsor: Dartmouth-Hitchcock Medical Center (other)
• Locations: 1 site (Lebanon, New Hampshire)
• Trial ID: NCT07109505 on ClinicalTrials.gov

What this trial studies

Community-dwelling patients aged 70 and older undergoing elective major abdominal or orthopedic surgery at Dartmouth-Hitchcock will be randomized to receive a provided daily nutritional shake for one month after hospital discharge or to receive standard postoperative nutritional instructions. Demographics, medical history, and medications will be obtained from the electronic health record and confirmed with the patient, and physical function and cognitive abilities will be measured during hospitalization and at follow-up. The shake contains a comprehensive panel of essential nutrients designed to support muscle, metabolic, and brain health. Patients with contraindications to MRI, inability to take oral nutrition, dementia, insulin-dependent diabetes, or other exclusions will be screened out per protocol.

Who should consider this trial

Good fit: Community-dwelling adults aged 70 or older scheduled for elective major abdominal or orthopedic surgery with a planned overnight hospital stay who can consent and tolerate oral nutrition are the ideal participants.

Not a fit: People with dementia or major psychiatric disease, insulin-dependent diabetes, inability to take oral nutrition, severe obesity (BMI >45), food allergies or caffeine intolerance, or those undergoing emergency surgery are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, the shake could speed physical recovery, protect thinking skills, and reduce postoperative complications in older patients.

How similar studies have performed: Prior trials of targeted protein or single-nutrient supplements in older surgical patients have shown some improvements in recovery, but broad-spectrum postoperative shakes like this formulation are relatively novel.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

* emergency surgery, diagnosis of dementia or major psychiatric diagnosis such as schizophrenia, Parkinson's disease, inability to consent for themselves, unwilling or unable to complete all study requirements and measurements, any known food allergy, dislike of shake flavor(s), unwilling or unable to tolerate caffeine in shake, unable to take oral nutrition, BMI \>45, diagnosis of an eating disorder, insulin dependent diabetes.
* MRI procedure eligibility will be assessed using the DHMC Department of Radiology's standard MRI Safety Checklist, which screens for potential contraindications to MRI scanning such as metal in the body, possible exposure to metal in the eyes, pregnancy, and claustrophobia. Any individual with a contraindication to MRI scanning will not be eligible to participate in the optional MRI component.

Where this trial is running

Lebanon, New Hampshire

• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (RECRUITING)

Study contacts

• Principal investigator: Stacie G Deiner, MD — Dartmouth-Hitchcock Medical Center
• Study coordinator: Stacie G Deiner, MD

Conditions: Postoperative Care, Postoperative Complications, Cognition, Nutritional Assessment, Nutritional Intervention, Nutrition, Postoperative