372 Participants Needed

Nutritional Supplements for Joint Replacement Recovery

Recruiting at 1 trial location
DW
DW
Ran Schwarzkopf, MD profile photo
Overseen ByRan Schwarzkopf, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Ensure for joint replacement recovery?

Research shows that nutritional supplements, like Ensure, can improve nutritional status in patients recovering from surgeries such as hip fractures, as indicated by increased albumin levels, a marker of nutrition. Additionally, high-protein supplements have been shown to enhance muscle protein synthesis and muscle mass in older adults, which may aid recovery.12345

Is the nutritional supplement generally safe for humans?

Current evidence shows no adverse effects of higher protein intakes, suggesting that the nutritional supplement is generally safe for humans.45678

How does the treatment of nutritional supplements for joint replacement recovery differ from other treatments?

This treatment is unique because it focuses on using nutritional supplements, such as high-protein or essential amino acids, to aid recovery after joint replacement surgery. Unlike traditional treatments that may focus on physical therapy or medication, these supplements aim to improve muscle strength and reduce muscle loss, potentially enhancing recovery outcomes.19101112

What is the purpose of this trial?

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.

Research Team

Ran Schwarzkopf, MD | NYU Langone Health

Ran Schwarzkopf, MD

Principal Investigator

NYU Langone

Eligibility Criteria

This trial is for people aged 55 to 95 who are about to have hip or knee replacement surgery and show signs of poor nutrition (low levels of certain proteins in their blood). It's not for those with revision surgeries, protein absorption issues, eating disorders, past septic arthritis, severe kidney/liver disease, allergies to oral supplements, or can't take them by mouth.

Inclusion Criteria

I am scheduled for a first-time hip or knee replacement surgery.
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
TSerum Albumin: ≤3.5 mg/dl Pre-Albumin: <15 mg/dl Transferrin: <200 mg/dl
See 1 more

Exclusion Criteria

I have had septic arthritis in the past.
You have an eating disorder.
You cannot take medicine or supplements by mouth.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Nutritional Optimization

Participants receive Ensure Max Protein Nutrition shake 2 weeks before surgery

2 weeks
1 visit (in-person)

Surgery and Immediate Post-operative

Participants undergo total joint replacement surgery and continue nutritional supplementation

2 weeks
1 visit (surgery day)

Follow-up

Participants are monitored for changes in hematological markers of malnutrition

4 weeks
1 visit (4 weeks post-surgery)

Treatment Details

Interventions

  • Ensure
Trial Overview The study tests if a nutritional drink called Ensure can improve blood markers related to nutrition in patients who don't get enough nutrients and are having joint replacement surgery.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Nutritional supplementationExperimental Treatment1 Intervention
Given Ensure Max Protein Nutrition shake 2 weeks before surgery and continued 2 weeks after surgery.
Group II: No Nutritional supplementationActive Control1 Intervention
Treatment as usual

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Findings from Research

In a study of 46 older adults recovering from hip fracture surgery, those who consumed a high-protein supplement (Boost HP) showed a significant improvement in serum albumin levels compared to those on a standard supplement (Ensure), indicating better protein status.
While both supplements were well tolerated and had similar consumption rates, the Boost HP group had a shorter rehabilitation stay (23 days vs. 28 days) and consumed more essential nutrients, suggesting potential benefits of high-protein supplementation in recovery.
Provision of high-protein supplement for patients recovering from hip fracture.Neumann, M., Friedmann, J., Roy, MA., et al.[2022]
In a study of 58 frail elderly women undergoing fast-track total hip arthroplasty, those who received exercise therapy combined with nutritional supplementation showed significant improvements in knee extensor muscle strength compared to those who only exercised.
However, the combination of exercise and nutrition did not lead to additional benefits in hip abductor strength, functional performance, or quality of life compared to exercise alone, suggesting that while nutrition may help with certain muscle strengths, it does not enhance overall recovery outcomes after surgery.
Effects of perioperative exercise therapy combined with nutritional supplementation on functional recovery after fast-track total hip arthroplasty.Ninomiya, K., Takahira, N., Ikeda, T., et al.[2023]
In a study of 1123 geriatric patients undergoing hip fracture surgery, the use of oral nutritional supplements (ONS) did not lead to a reduction in perioperative complications or mortality rates at 30 days, 90 days, or 1 year.
However, patients receiving ONS had significantly higher albumin levels before discharge, indicating an improvement in nutritional status, which may warrant further investigation into its long-term effects on recovery and functional outcomes.
Efficacy of Oral Nutritional Supplements in Patients Undergoing Surgical Intervention for Hip Fracture.Ashkenazi, I., Rotman, D., Amzalleg, N., et al.[2022]

References

Provision of high-protein supplement for patients recovering from hip fracture. [2022]
Effects of perioperative exercise therapy combined with nutritional supplementation on functional recovery after fast-track total hip arthroplasty. [2023]
Efficacy of Oral Nutritional Supplements in Patients Undergoing Surgical Intervention for Hip Fracture. [2022]
Supplementing Breakfast with a Vitamin D and Leucine-Enriched Whey Protein Medical Nutrition Drink Enhances Postprandial Muscle Protein Synthesis and Muscle Mass in Healthy Older Men. [2023]
Dietary protein and bone health: a systematic review and meta-analysis from the National Osteoporosis Foundation. [2023]
Feasibility and acceptability of a milk and resistance exercise intervention to improve muscle function in community-dwelling older adults (MIlkMAN): Pilot study. [2020]
Amount and type of protein influences bone health. [2023]
Greater stimulation of myofibrillar protein synthesis with ingestion of whey protein isolate v. micellar casein at rest and after resistance exercise in elderly men. [2022]
A whey protein-based multi-ingredient nutritional supplement stimulates gains in lean body mass and strength in healthy older men: A randomized controlled trial. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Supplement Use in Patients Undergoing Anterior Cruciate Ligament Reconstruction: A Systematic Review. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Creatine monohydrate supplementation does not improve functional recovery after total knee arthroplasty. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Essential Amino Acid Supplementation Mitigates Muscle Atrophy After Total Knee Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial. [2022]
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