Nutrition to Support Postoperative Recovery

Dartmouth Health

Status: Not yet enrolling

Conditions: Postoperative Complications; Postoperative Care; Nutritional Intervention; Cognition; Nutritional Assessment

Treatments: Other: Nutritional Instructions Only; Dietary Supplement: Nutritional Shake

Study type: Interventional

Funder types: Other

Identifiers

NCT07109505

STUDY02002743

Details and patient eligibility

About

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.

Full description

We will recruit a cohort of community dwelling patients, age 70 years and older for elective major abdominal and orthopedic surgery. Demographics, medical history, medications will be obtained from the electronic health record and confirmed with the patient. Patients randomized to the nutrition shake arm will receive a provided daily nutritional shake (starting when they leave the hospital and for 1-month after hospital discharge). The shake consists of a comprehensive panel of essential nutrients to support maintenance of muscle, metabolic and brain health.

Enrollment: 100 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Shake and instructions

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Nutritional Shake

Nutrition Instructions Only

Other group

Description:

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

Treatment:

Other: Nutritional Instructions Only