Cognition, Nutritional Assessment, Nutritional Intervention, Postoperative Care, Postoperative Complications
Conditions
Keywords
Nutrition, Postoperative, Cognition
Brief 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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTNutritional Shake
The shake mixes will be dry shelf -stable powders prepared with ingredients readily available in the US food supply and contain a minimum of 990 mg total cocoa flavanols, with a profile to support general nutritional health including 10 g protein. Accordingly, each shake contains approximately 95 mg of caffeine, equivalent to a medium-sized cup of coffee. Based on prior studies of cognition, additional composition specifications are: 1600 mg DHA and up to 400 mg EPA and 550 mg choline; \>250 mg epicatechin and epigallocatechin (plant polyphenols); multivitamin/mineral fortification to ensure 50-100% of all essential micronutrients except calcium (to prevent competitive absorption with other divalent cations). Participants will be given a supply of pre-portioned daily servings upon discharge from the hospital, for 30 days after surgery.
OTHERNutritional 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
Sponsors
Dartmouth-Hitchcock Medical Center
Hitchcock Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Masking description
The randomization assignment (shake and instructions or instructions only) will not be double blinded since the participants will know if they receive a shake mix or not. However, the coordinator performing assessments after discharge will be blinded to group. A separate, unblinded study team member will track compliance (see above).
Intervention model description
The randomization assignment will consist of two groups: Shake and instructions or instructions only.
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aim 1a: Postoperative change in disability scores | 90 days | This aim will compare postoperative change in disability scores, as measured by World Health Organization Assessment Schedule 2.0 (WHODAS 2.0), from baseline to 1 month and baseline to 3 months. Results will be scored on a 5-point Likert scale and summed to a total score ranging 0 to 100, where 0 indicates no disability and 100 indicates full disability. The outcome will compare patients receiving a 30-day supply of daily nutritional shake and general healthy nutrition recommendations versus those only receiving general healthy nutrition recommendations without a provided shake |
| Aim 1b: Postoperative change in cognitive function | 90 days | This aim will compare postoperative change in cognitive function, as measured by The Montreal Cognitive Assessment (T-MoCA), from baseline to 1 month and baseline to 3 months. Scores will range from 0 to 30 points, with higher scores indicating greater cognitive function. The outcome will compare patients receiving a 30-day supply of a daily nutritional shake and general healthy nutritional recommendations versus those receiving only healthy nutritional recommendations without a provided shake. |
Countries
United States
Contacts
CONTACTStacie G Deiner, MD
CONTACTAlexander R Roth, BA
PRINCIPAL_INVESTIGATORStacie G Deiner, MD
Dartmouth-Hitchcock Medical Center
Outcome results
None listed