Nutrition to Support Postoperative Recovery

NCT07109505 | Recruiting

• 1 other identifier: STUDY02002743
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Nutrition; Postoperative; Cognition

Outcome Measures

Primary Outcomes (2)

• Aim 1a: Postoperative change in disability scores

  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

  90 days

• Aim 1b: Postoperative change in cognitive function

  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.

  90 days

Other Outcomes (2)

• Banking of blood specimens for future analysis

  day of surgery and postoperative day 1

• Feasibility of MRI scan 30 days after surgery

  30 days after surgery

Study Arms (2)

Shake and instructions

EXPERIMENTAL

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.

Dietary Supplement: Nutritional Shake

Nutrition Instructions Only

OTHER

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

Other: Nutritional Instructions Only

Interventions

Nutritional Instructions Only OTHER

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

Nutrition Instructions Only

Nutritional Shake DIETARY_SUPPLEMENT

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.

Shake and instructions

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Hitchcock Foundation: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Related Publications (18)

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MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stacie G Deiner, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stacie G Deiner, MD

CONTACT

(603) 650-5922; Stacie.G.Deiner@hitchcock.org

Alexander R Roth, BA

CONTACT

(603) 650-0397; Alexander.R.Roth@hitchcock.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LeRoy Garth Professor and Vice Chair for Research, Department of Anesthesiology

Model Details: The randomization assignment will consist of two groups: Shake and instructions or instructions only.

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: August 7, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 11, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)