Recruiting

Nutritional Shake

Sponsor:

Dartmouth-Hitchcock Medical Center

Code:

NCT07109505

Conditions

Postoperative Care

Postoperative Complications

Cognition

Nutritional Assessment

Nutritional Intervention

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Accepted

Interventions

Nutritional Shake

Nutritional Instructions Only

Study Details

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 Care

Postoperative Complications

Cognition

Nutritional Assessment

Nutritional Intervention

Study ID

NCT07109505

Start date

Dec 10, 2025

Status verified date

Nov, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Shake and instructions

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.

other: Nutrition 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

Interventions

Nutritional 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.

Nutritional 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

Primary outcome measure

  • Aim 1a: Postoperative change in disability scores [ Time Frame: 90 days ]
  • Aim 1b: Postoperative change in cognitive function [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Stacie G Deiner, MD

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

Alexander R Roth, BA

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

Locations

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Stacie G Deiner, MD

631-974-2444Stacie.G.Deiner@hitchcock.org

Emma K Toes, BA

603-650-0381Emma.K.Toes@hitchcock.org

More Information

Sponsor

Dartmouth-Hitchcock Medical Center

Last update posted

Feb 11, 2026

Last verified

Nov, 2025

Keywords

  • Nutrition
  • Postoperative
  • Cognition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center on 2026-02-11.