MalnutritionNCT03073811

Nutritional Perihabilitation in Older Veterans Undergoing Surgery

A study testing Protein enhanced nutrition intervention in people with Malnutrition and Nutritional Risk, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 years and older
Conditions the study is for: Malnutrition, Nutritional Risk, Abdominal Surgery
What is being tested?: Protein enhanced nutrition intervention
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 20 Jun 2017to 31 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Elective abdominal surgery
upper GI
colorectal
hepatobiliary
pancreatic
intra-abdominal

Show all 9Show fewer

Abdominal aortic aneurysm
Referred to the VA Perioperative Optimization of Senior Health Clinic
Able to record dietary intake or has a proxy who can record dietary intake

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested: Protein enhanced nutrition intervention, Education Control
Keywords: protein supplementation, older adults, nutrition perihabilitation, perioperative optimization, Veterans
Medical subject headings: Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Protein enhanced nutrition interventionDietary supplement
Also called Perihabilitation
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.
Education ControlOther
Also called PoshControl
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.

Study groups in NCT03073811
Study group	Role	What they receive
PeriHab	Experimental	Provided nutrition counseling and prescribed to consume 1.6 g/kg/body weight as well as provided 30 grams of high quality protein three times per day for two weeks before and four weeks after surgery. Receives: Dietary Supplement: Protein enhanced nutrition intervention
PoshControl	Active comparator	Provided nutrition counseling and prescribed to consume 1.0 g/kg/body weight in the form of educational handouts explained by a Registered Dietitian and one oral nutrition supplement per day for two weeks before surgery. Receives: Other: Education Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm.
Feasibility was measured as retention. Hypothesis was that 80% of the participants would be retained.
Measured: day of surgery (an average of 12 days from baseline [midpoint]) and 30-day post-surgery (endpoint)
Determine Acceptability of Perioperative Protein-enhanced Intervention Compared to an Educational Control
Satisfaction of overall participation in the research study (Likert Scale). I am glad I participated in this research study. 1 - Strongly Disagree and 5- Strongly Agree
Measured: 30-day post-surgery follow-up (endpoint)
Physical Function
Short physical performance battery - higher scores means a better physical performance (Total score = 0-12)
Measured: Baseline, day of surgery (an average of 12 days from baseline), 30-days post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jun 201731 Mar 2022

First posted8 Mar 2017
Study start20 Jun 2017
Primary completion31 Mar 2022
Study completion31 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MalnutritionStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03073811
Sponsor's protocol ID: E2348-W
Other IDs: IK2RX002348
Status last verified: Aug 2026
First submitted: 23 Feb 2017
Last updated: 21 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nutritional (High Protein) Perihabilitation in Older Veterans Undergoing Surgery
ClinicalTrials.gov ID: NCT03073811
Acronym / sponsor ID: E2348-W
Conditions: Malnutrition, Nutritional Risk, Abdominal Surgery
Keywords: protein supplementation, older adults, nutrition perihabilitation, perioperative optimization, Veterans
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 20 Jun 2017 (actual)
Primary completion: 31 Mar 2022 (actual)
Study completion: 31 Mar 2022 (actual)
First posted: 8 Mar 2017 (actual)
Results: Posted 31 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PeriHab	Experimental	Dietary Supplement: Protein enhanced nutrition interventionProvided nutrition counseling and prescribed to consume 1.6 g/kg/body weight as well as provided 30 grams of high quality protein three times per day for two weeks before and four weeks after surgery.
PoshControl	Active comparator	Other: Education ControlProvided nutrition counseling and prescribed to consume 1.0 g/kg/body weight in the form of educational handouts explained by a Registered Dietitian and one oral nutrition supplement per day for two weeks before surgery.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Elective abdominal surgery
Referred to the VA Perioperative Optimization of Senior Health Clinic
Able to record dietary intake or has a proxy who can record dietary intake

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Protein enhanced nutrition interventionAlso: PerihabilitationParticipants 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.	Dietary supplement	PeriHab
Education ControlAlso: PoshControlprovided 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.	Other	PoshControl

Primary outcome

Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm.
Time frame: day of surgery (an average of 12 days from baseline [midpoint]) and 30-day post-surgery (endpoint)
Feasibility was measured as retention. Hypothesis was that 80% of the participants would be retained.
Determine Acceptability of Perioperative Protein-enhanced Intervention Compared to an Educational Control
Time frame: 30-day post-surgery follow-up (endpoint)
Satisfaction of overall participation in the research study (Likert Scale). I am glad I participated in this research study. 1 - Strongly Disagree and 5- Strongly Agree
Physical Function
Time frame: Baseline, day of surgery (an average of 12 days from baseline), 30-days post-surgery
Short physical performance battery - higher scores means a better physical performance (Total score = 0-12)

Results and safety

Results posted to the registry on 31 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PeriHab	26	19
PoshControl	24	16

Primary outcome: Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm.

Time frame: day of surgery (an average of 12 days from baseline [midpoint]) and 30-day post-surgery (endpoint). Count of participants. Unit: Participants

Measure	PeriHab n = 26	PoshControl n = 24
Day of Surgery	23	20
Postoperative Follow-up	19	16

Primary outcome: Determine Acceptability of Perioperative Protein-enhanced Intervention Compared to an Educational Control

Time frame: 30-day post-surgery follow-up (endpoint). Mean (Standard Deviation). Unit: units on a scale

Measure	PeriHab n = 19	PoshControl n = 16
Value	4.6 (0.6)	4.9 (0.3)

Primary outcome: Physical Function

Time frame: Baseline, day of surgery (an average of 12 days from baseline), 30-days post-surgery. Mean (Standard Deviation). Unit: score on a scale

Measure	PeriHab n = 26	PoshControl n = 24
Baseline	8.2 (2.6)	7.9 (2.4)
Morning of Surgery (midpoint)	9.7 (2.3)	9.0 (2.0)
30 day postop (endpoint)	9.0 (2.9)	8.8 (2.3)

Population analysed: Perihab (midpoint; n=23) - surgery was cancelled (n=3) PoshControl (midpoint; n=18) - surgery was cancelled (n=3), dropped (n=1); surgery time changed (n=2) Perihab (endpoint; n=18) - surgery was cancelled morning of surgery (n=2); death (n=1); COVID (n=2) PoshControl (n=16; endpoint) - surgery was cancelled morning of surgery (n=2); death (n=1); hospitalization (n=1)

Adverse events

Time frame: Adverse event data was collected for each participant from enrollment to study completion or study withdraw. The duration of participation in the study was approximately 8 weeks.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PeriHab	2 of 26 (7.7%)	1 of 26 (3.8%)	1 of 26
PoshControl	1 of 24 (4.2%)	0 of 24 (0%)	1 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kathryn N. Starr, PhD principal investigator

Durham VA Medical Center, Durham, NC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Protein enhanced nutrition intervention in people with Malnutrition and Nutritional Risk, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the Feasibility of a Perioperative Protein-enhanced Intervention Compared to Control Arm. (time frame: day of surgery (an average of 12 days from baseline [midpoint]) and 30-day post-surgery (endpoint)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03073811.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.