Nutritional Supplements for Joint Replacement Recovery

Recruiting at 1 trial location

Overseen By Ran Schwarzkopf, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

372 Participants Needed

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. ^{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}

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

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.

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

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+

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Oral Nutritional Supplements in Patients Undergoing Surgical Intervention for Hip Fracture. Ashkenazi, I., Rotman, D., Amzalleg, N., 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]

The MilkMAN study demonstrated that a community-based intervention combining milk consumption with resistance exercise is feasible and well-accepted among older adults, with a high attendance rate of 97.1% and excellent participant feedback.

While the intervention did not show significant differences in muscle function measures like grip strength and gait speed among the different milk types and carbohydrate drink, it successfully gathered pilot data to inform future research on combating sarcopenia.

NCBI (Pubmed)

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. Granic, A., Hurst, C., Dismore, L., et al.[2020]

Adequate protein and calcium intake are crucial for maintaining bone health, especially in the elderly, and optimal protein levels may need to be higher than current recommendations to combat age-related bone and muscle loss.

Concerns about dietary protein leading to increased urinary calcium and acid production are outweighed by the benefits of protein on bone health, suggesting that increasing fruit and vegetable intake may be more important than reducing protein sources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amount and type of protein influences bone health. Heaney, RP., Layman, DK.[2023]

In a study involving 14 healthy elderly men, consuming 20 grams of whey protein isolate resulted in a 65% higher rate of myofibrillar protein synthesis (MPS) at rest compared to micellar casein, indicating whey is more effective for muscle protein synthesis.

After resistance exercise, whey protein also led to significantly greater MPS rates than micellar casein, suggesting that whey may enhance recovery and muscle building in older adults due to its ability to increase blood amino acid levels more effectively.

NCBI (Pubmed)

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. Burd, NA., Yang, Y., Moore, DR., et al.[2022]

In a study of 49 healthy older men, consuming a protein-based nutritional supplement twice daily for 20 weeks significantly increased muscle strength and lean mass compared to a control group, with notable gains in strength during the initial 6 weeks without exercise.

The benefits of the supplement were further enhanced when combined with exercise, leading to greater upper body strength at the end of the study, demonstrating its efficacy in promoting muscle health in older adults.

NCBI (Pubmed)

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. Bell, KE., Snijders, T., Zulyniak, M., et al.[2022]

Protein and amino acid supplementation may help reduce muscle atrophy and improve rehabilitation outcomes in patients after anterior cruciate ligament reconstruction (ACLR), as shown by multiple studies assessing rehabilitation benchmarks and muscle strength.

In contrast, creatine, vitamin, and hormone-based supplements did not show benefits in preventing muscle atrophy post-surgery, and some vitamins like C and E may even increase local inflammation in skeletal muscle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplement Use in Patients Undergoing Anterior Cruciate Ligament Reconstruction: A Systematic Review. Greif, DN., Emerson, CP., Allegra, P., et al.[2021]

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]

In a study of 39 older adults undergoing total knee arthroplasty, perioperative supplementation with essential amino acids (EAA) significantly reduced muscle atrophy in both the quadriceps and hamstrings compared to a placebo, indicating its efficacy in preserving muscle volume during recovery.

The EAA supplementation was found to be safe for older adults, with no significant differences in blood chemistry values between the EAA and placebo groups, suggesting it can be a beneficial addition to postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essential Amino Acid Supplementation Mitigates Muscle Atrophy After Total Knee Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial. Dreyer, HC., Owen, EC., Strycker, LA., et al.[2022]

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

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

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

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

8. 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]

9. 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]

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

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

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

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

12. 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]