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Oral Nutritional Optimization in Total Joint Arthroplasty

NCT04210284 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-09-11

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

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

Sponsors & Collaborators

Principal Investigators

  • Ran Schwarzkopf · NYU Langone

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-06
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04210284 on ClinicalTrials.gov