NCT03073811

Nutritional Perihabilitation in Older Veterans Undergoing Surgery

Nutritional (High Protein) Perihabilitation in Older Veterans Undergoing Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Malnutrition
• Nutritional Risk
• Abdominal Surgery

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Protein enhanced nutrition intervention	Participants will be provided 30 grams of high quality protein (Ensure Max) three times a day for two weeks before surgery and four weeks after surgery.
OTHER	Education Control	provided educational on the role of nutrition to prepare for and heal from surgery, and Registered Dietitian will instruct participant to follow instruction on handout and one oral nutrition supplement per day for two week before surgery.

Timeline

• Start date: 2017-06-20
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2017-03-08
• Last updated: 2025-04-01
• Results posted: 2024-01-31

Locations

1 site across 1 country: United States