Nutritional Perihabilitation in Older Veterans Undergoing Surgery



Status:Recruiting
Conditions:Food Studies, Post-Surgical Pain
Therapuetic Areas:Musculoskeletal, Pharmacology / Toxicology
Healthy:No
Age Range:65 - Any
Updated:3/23/2019
Start Date:June 20, 2017
End Date:February 28, 2022
Contact:Kathryn N Starr, PhD
Email:kathryn.starr@duke.edu
Phone:(919) 286-0411

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Nutritional (High Protein) Perihabilitation in Older Veterans Undergoing Surgery

This research study will be conducted in two parts. The first part will consist of selecting
appropriate screening and assessment tools for Veterans undergoing elective surgery and
identifying the number of Veterans who are malnourished and at risk of malnutrition. The
second portion of the study will be to determine if a protein-enhanced diet before and after
surgery will improve function and postoperative outcomes and compare the results to an
education control group.

In year 1 of the two-part research study, an observational, prospective study of 75 Veterans
preparing for elective surgery will be conducted. The purpose of this study will be to select
appropriate nutrition screening and assessment tools and to employ them to characterize
malnutrition prevalence and severity and establish cut-off values associated with
malnutrition in this population. In years 2-5 of the research two-part research study, a
pilot randomized controlled trial will be conducted. The purpose of this study will be
evaluate the feasibility, fidelity, and acceptability of a perioperative protein-enhanced
intervention compared to an educational control. Veterans who are malnourished or at risk of
being malnourished will be randomly assigned on a 1:1 ratio to either an education
(nutritional counseling) control or high-protein perihabilitation arm. Participants in the
high-protein perihabilitation arm will be provided with 30 grams of high quality protein
supplements three times per day. The study will take place two weeks prior to an elective
abdominal or GI surgery and will continue 4 weeks post surgery.

Inclusion Criteria:

- Elective abdominal surgery

- upper GI

- colorectal

- hepatobiliary

- pancreatic

- intra-abdominal

- Referred to the VA Perioperative Optimization of Senior Health Clinic

- Able to record dietary intake or has a proxy who can record dietary intake

Exclusion Criteria:

- Cognitive impairment

- Unwillingness to be randomized to either intervention arm, submit to study testing, or
continuously participate in the intervention for six weeks

- Living in skilled nursing facility

- No access to telephone
We found this trial at
1
site
Durham, North Carolina 27705
Principal Investigator: Kathryn N. Starr, PhD
Phone: 919-286-0411
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Durham, NC
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