Nutrition to Support Postoperative Recovery

Part of paid clinical trials in Lebanon, New Hampshire.

Sponsor
Dartmouth-Hitchcock Medical Center
Study ID
NCT07109505
Status
Recruiting
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Conditions

  • Cognition
  • Nutritional Assessment
  • Nutritional Intervention
  • Postoperative Care
  • Postoperative Complications

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.
  • 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

Study Details

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.

Key Dates

Start date
Dec 10, 2025
Status verified
Nov 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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

Primary Outcome Measure

Aim 1a: Postoperative change in disability scores [ Time Frame: 90 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756
Stacie G Deiner, MD
[email protected]
631-974-2444
Emma K Toes, BA
[email protected]
603-650-0381

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