Nutritional Supplements for Joint Replacement Recovery

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Ran Schwarzkopf, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: NYU Langone Health

Disqualifiers: Septic arthritis, Allergy, Protein malabsorption, Eating disorders, End stage renal, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{4 5 6 7 8}

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. ^{1 9 10 11 12}

Research Team

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

Exclusion Criteria

I have had septic arthritis in the past.

You have an eating disorder.

You cannot take medicine or supplements by mouth.

Trial 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 (Dietary Supplement)

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

Group I: Nutritional supplementation Experimental Treatment 1 Intervention

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

Group II: No Nutritional supplementation Active Control 1 Intervention

Treatment as usual

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Dr. Alec C. Kimmelman

NYU Langone Health

Chief Executive Officer

MD and PhD from Mount Sinai School of Medicine

Dr. Nicole M. Adler

NYU Langone Health

Chief Medical Officer since 2023

MD

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provision of high-protein supplement for patients recovering from hip fracture. Neumann, M., Friedmann, J., Roy, MA., et al.[2022]

Supplementing breakfast with a vitamin D and leucine-enriched whey protein drink significantly increased postprandial muscle protein synthesis in healthy older adults, indicating a beneficial effect on muscle anabolism.

After 6 weeks, participants who consumed the protein drink gained more appendicular lean mass compared to the control group, suggesting that this intervention can help preserve and build muscle mass in older individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Chanet, A., Verlaan, S., Salles, J., et al.[2023]

A systematic review of 16 randomized controlled trials and 20 cohort studies found that higher dietary protein intake may positively affect lumbar spine bone mineral density (BMD), showing a moderate protective effect compared to lower protein intake.

However, there was no significant impact of protein intake on total hip, femoral neck, or total body BMD, and limited evidence suggested that combining protein with calcium and vitamin D did not enhance bone health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary protein and bone health: a systematic review and meta-analysis from the National Osteoporosis Foundation. Shams-White, MM., Chung, M., Du, M., et al.[2023]

In a randomized trial involving 37 adults undergoing total knee arthroplasty, creatine monohydrate supplementation did not lead to improvements in body composition or muscle strength post-surgery.

Despite the supplementation, participants experienced a significant decrease in quadriceps and ankle dorsiflexion strength 30 days after surgery, indicating that creatine did not enhance recovery from the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creatine monohydrate supplementation does not improve functional recovery after total knee arthroplasty. Roy, BD., de Beer, J., Harvey, D., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Provision of high-protein supplement for patients recovering from hip fracture. [2022]

2. Japan pubmed.ncbi.nlm.nih.gov

Effects of perioperative exercise therapy combined with nutritional supplementation on functional recovery after fast-track total hip arthroplasty. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Oral Nutritional Supplements in Patients Undergoing Surgical Intervention for Hip Fracture. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

Dietary protein and bone health: a systematic review and meta-analysis from the National Osteoporosis Foundation. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Amount and type of protein influences bone health. [2023]

7. England pubmed.ncbi.nlm.nih.gov

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]

8. United States pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a milk and resistance exercise intervention to improve muscle function in community-dwelling older adults (MIlkMAN): Pilot study. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Supplement Use in Patients Undergoing Anterior Cruciate Ligament Reconstruction: A Systematic Review. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Creatine monohydrate supplementation does not improve functional recovery after total knee arthroplasty. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Essential Amino Acid Supplementation Mitigates Muscle Atrophy After Total Knee Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

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]