Recruiting

Nutritional Optimization

Sponsor:

NYU Langone Health

Code:

NCT04210284

Conditions

Osteoarthritis

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Ensure

Study Details

Brief summary:

The purpose of this study is to determine the effect on hematological markers of nutritional intervention on nutritionally deficient patients following total joint replacement surgery.

Conditions

Osteoarthritis

Study ID

NCT04210284

Start date

Jul 6, 2021

Status verified date

Sep, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patient are current candidates for elective primary total hip and total knee arthroplasty
2. Patients ≥55 years of age but ≤ 95
3. Patients who meet at least one of the following three laboratory criteria for malnutrition:

TSerum Albumin: ≤3.5 mg/dl Pre-Albumin: <15 mg/dl Transferrin: <200 mg/dl

Exclusion Criteria:

1. Previous history of septic arthritis
2. Allergy to oral supplementation
3. Inability to consume oral supplementation
4. Protein malabsorption syndromes
5. Eating disorders
6. End stage renal and hepatic disease
7. Revision surgery, non-elective surgery, hemiarthroplasty, and unicompartmental knee arthroplasty

Study Design

Enrollment

72 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nutritional supplementation

Given Ensure Max Protein Nutrition shake 2 weeks before surgery and continued 2 weeks after surgery.

no intervention: No Nutritional supplementation

Treatment as usual

Interventions

Ensure

Ensure Max Protein Shake is an over the counter available drinkable nutritional supplement. Per serving, it contains:

  • 160 Calories, 20 from fat
  • 2g Total fat
  • 0.5g Saturated fat
  • 20mg Cholesterol
  • 135mg Sodium
  • 170mg Potassium
  • 19g Total carbohydrate
  • <1g Fiber
  • 4g Sugar
  • 16g Protein

Participants will receive Ensure High Protein for 2 weeks pre- and 4 weeks post-operatively. These patients will be instructed to consume 1 serving (16fl oz) of Ensure High Protein daily. They will be provided with this product at a pre-operative clinical visit or have it mailed to their home. Hematologic nutritional values will be measured as specified previously.

Descriptive statistics will be used to report baseline characteristics and primary study objectives. Hematologic outcomes will be compared between the control ("NO ENSURE") and oral supplementation ("ENSURE") arms for the aforementioned baseline and perioperative variables

Primary outcome measure

  • Changes in the patients' albumin, pre-albumin, and/or transferrin levels [ Time Frame: Visit 2 (2 wks pre) Visit 3 (surgery day) Visit 5 (4 weeks post) ]

Central Contacts and Locations

Central contacts

Daniel Waren

212-598-6245Daniel.waren@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Daniel Waren

212-598-6245daniel.waren@nyulangone.org

Principal Investigator:

Ran Schwarzkopf, MD

Rothman Orthopedic Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Alicia Reyes

267-339-3627Alicia.Reyes@rothmanortho.com

More Information

Sponsor

NYU Langone Health

Last update posted

Sep 11, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2025-09-11.