Actively Recruiting

Phase Not Applicable
Age: 70Years +
All Genders
Healthy Volunteers
ID07109505

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

Led by Dartmouth-Hitchcock Medical Center · Updated on 2026-02-11

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

D

Dartmouth-Hitchcock Medical Center

Lead Sponsor

H

Hitchcock Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying older adults aged 70 years and above who are undergoing major orthopedic or abdominal surgery. The study evaluates whether giving a specially designed nutritional shake after surgery can help improve physical function and cognitive abilities during recovery. This trial aims to gather data on the role of nutrition in recovery for frail older surgical patients, with the goal of informing future larger studies on optimizing recovery through nutritional support. Participants will be randomly assigned to one of two groups. One group will receive standard nutritional instructions after surgery, while the other group will receive the same instructions plus a daily nutritional shake for 30 days following hospital discharge. The shake contains a balanced mix of essential nutrients, including protein, cocoa flavanols, omega-3 fatty acids, choline, polyphenols, and multivitamins to support muscle, metabolic, and brain health. During the study, participants' demographics, medical history, and medication use will be collected. Researchers will assess physical function and cognitive abilities while participants are in the hospital and again 90 days after surgery. Participants in the shake group will track their daily shake intake through logs submitted online, which the study team will review for adherence and any side effects. The main outcomes measured are changes in disability and cognitive function 90 days after surgery, with ongoing monitoring throughout the study period.

CONDITIONS

Brief Title

Nutrition to Support Postoperative Recovery

Who Can Participate

Age: 70Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 70 years or older
  • Scheduled for major orthopedic or abdominal surgery requiring at least one overnight hospital stay
Not Eligible

You will not qualify if you...

  • Emergency surgery
  • Diagnosis of dementia or major psychiatric conditions such as schizophrenia or Parkinson's disease
  • Unable to consent or unwilling/unable to complete all study requirements and measurements
  • Known food allergy or dislike of shake flavors
  • Unwilling or unable to tolerate caffeine in the shake
  • Unable to take oral nutrition
  • Body mass index (BMI) greater than 45
  • Diagnosis of an eating disorder
  • Insulin-dependent diabetes
  • Contraindications to MRI scanning for those opting to participate in the MRI component, such as metal in the body, pregnancy, or claustrophobia

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Hospital stay (at least one overnight)

Participants undergo elective major abdominal or orthopedic surgery and receive immediate post-operative care during their hospital stay.

1 hospitalization period

Treatment

Duration - 30 days after hospital discharge

Participants in the intervention arm receive a daily nutritional shake starting upon hospital discharge, along with nutritional instructions. The control arm receives nutritional instructions only. Participants are instructed to consume the shake daily for 30 days and track their consumption.

1 visit at discharge and daily self-administration at home

Follow-up

Duration - Up to 90 days after surgery

Participants are monitored for postoperative recovery, including disability and cognitive function, up to 90 days after surgery.

Follow-up visits as scheduled for assessments

Trial Site Locations

Total: 1 location

1

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

Actively Recruiting

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Research Team

S

Stacie G Deiner, MD

A

Alexander R Roth, BA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Association of mild and complex multimorbidity with structural brain changes in older adults: A population-based study.

Martina Valletta, Davide Liborio Vetrano, Amaia Calderón-Larrañaga...

https://pubmed.ncbi.nlm.nih.gov/38170758