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

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a nutritional supplement, given as Ensure Max Protein shakes, might aid recovery from joint replacement surgery. It aims to determine if these shakes can improve blood health markers in patients lacking sufficient nutrients. The trial includes two groups: one will consume Ensure shakes before and after surgery, while the other will maintain their usual diet. Suitable candidates are those planning hip or knee replacement surgery and needing more nutrients in their diet. As an unphased trial, this study provides a unique opportunity to enhance understanding of nutritional recovery strategies after 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that Ensure Max Protein is safe for most people. This nutrition shake is low in fat, contains 30 grams of protein, and has only 1 gram of sugar. It is designed to help those who need more protein. The shake also includes 25 vitamins and minerals and is free from lactose and gluten, making it suitable for individuals with certain food sensitivities.

Ensure Max Protein is often used to aid recovery after surgery. It contains nutrients like arginine and omega-3 fatty acids, which support healing. While some individuals might experience mild stomach discomfort, serious side effects are rare. Overall, the shake is considered well-tolerated and safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Ensure as a nutritional supplement for joint replacement recovery because it offers a simple, non-invasive way to potentially enhance healing. Unlike traditional recovery methods that focus on physical therapy and pain management, Ensure provides targeted nutritional support that may boost the body's internal healing processes. By delivering high-quality protein and essential nutrients, it could speed up recovery and improve overall outcomes for patients undergoing surgery.

What evidence suggests that this trial's treatments could be effective for joint replacement recovery?

This trial will compare the effects of nutritional supplementation with Ensure to no supplementation for joint replacement recovery. Research has shown that drinking Ensure can aid recovery after surgery. It is rich in protein, which is crucial for wound healing and recovery improvement. Ensure also supports the immune system, which is vital post-surgery. Protein assists the body in repairing itself, and Ensure provides a substantial amount. While it aids in recovery, note that some protein shakes have been reported to contain high levels of lead. Always consult a healthcare professional before starting any new supplement. ^{2 6 7 8 9}

Who Is on the Research Team?

Ran Schwarzkopf, MD

Principal Investigator

NYU Langone

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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 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 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 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]

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]

Citations

1. ensure.ca ensure.ca/en/recovering-from-surgery

Recovering from Surgery Eating well-balanced meals high in protein can help you recover from surgery or illness. Use Ensure® to supplement your nutrition – your body needs you!

2. abbottnutrition.com abbottnutrition.com/our-products/ensure-surgery

Ensure® Surgery Ensure Surgery is an immunonutrition shake designed to support immune health and recovery from surgery, for oral use under medical supervision.

3. ensure.com ensure.com/nutrition-products/ensure-surgery

Ensure® Surgery Drink | Liquid Diet After ... Ensure Surgery is calorically dense (1.39 kcal/mL), with high protein to support wound healing and improve outcomes. The caloric density of Ensure Surgery ...

4. consumerreports.org consumerreports.org/lead/protein-powders-and-shakes-contain-high-levels-of-lead-a4206364640/

Protein Powders and Shakes Contain High Levels of Lead CR tests of 23 popular protein powders and shakes found that most contain high levels of lead.

5. ods.od.nih.gov ods.od.nih.gov/factsheets/ExerciseAndAthleticPerformance-HealthProfessional/

Dietary Supplements for Exercise and Athletic Performance This fact sheet provides an overview of selected ingredients in dietary supplements designed or claimed to enhance exercise and athletic performance.

6. abbottnutrition.com abbottnutrition.com/our-products/ensure-max-protein

Ensure® Max Protein ENSURE MAX PROTEIN is a high-protein, low-fat nutrition shake with 1 g of sugar for people who need extra protein.

7. ensure.com ensure.com/nutrition-facts-questions-answers

Nutrition Questions & Answers Ensure FAQs cover questions about ingredients, sugar, if it's for diabetics, if it helps with weight gain/loss, and if it's gluten-free.

8. aapa.org aapa.org/wp-content/uploads/2021/05/Ensure-Resource.pdf

Ensure® Max Protein Ensure Max Protein has 30g of protein, less sugar, and is low in fat and cholesterol, with 150 calories and 8 B vitamins for energy. It is designed to replace ...

9. family.abbott family.abbott/sg-en/ensure/products/ensure-max-protein.html

Ensure® Max Protein - Abbott Family Ensure Max Protein has 30g protein, 4g fiber, 150 calories, 1g sugar, 2g fat, 25 vitamins & minerals, and is lactose/gluten free. It helps muscle building.