Amino Acid Supplements for Broken Bones

Recruiting at 1 trial location

Overseen By Ashley S Kochuyt, BS

Age: 65+

Sex: Any

Trial Phase: Phase 2

Sponsor: Michael C Willey

Disqualifiers: Cognitive impairment, Electrical implants, Non-ambulatory, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 14

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether essential amino acid (EAA) supplements aid in muscle strength recovery and inflammation reduction after surgery for a broken thigh bone. It compares individuals taking the supplements to those receiving standard care without them. The goal is to determine if the supplements improve muscle health and physical performance up to six months post-surgery. Suitable participants have experienced a low-energy injury, such as a fall, and are hospitalized for a surgically repaired broken femur. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant findings.

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 essential amino acid supplementation is likely to be safe for humans?

Research has shown that essential amino acid (EAA) supplements are generally safe for people. In past studies, patients who took EAA supplements after surgery experienced fewer complications and less muscle loss. One study found that taking EAA and glutamine supplements for a few weeks helped maintain muscle strength and size.

Another study demonstrated that taking amino acid supplements twice a day for two weeks reduced early muscle loss and lowered the risk of complications. These findings suggest that EAA supplements not only support muscle health but are also safe for post-surgery use. Although this trial is in an early stage and focuses on broken bones, current evidence indicates that any side effects are minor and manageable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for broken bones?

Unlike the standard care for broken bones, which typically involves pain management and physical therapy, the new treatment uses essential amino acid (EAA) supplementation to potentially enhance recovery. This approach is unique because EAAs are the building blocks of proteins, essential for tissue repair and muscle growth. Researchers are excited about this treatment because it could accelerate healing by providing the specific nutrients needed for bone and tissue repair, starting as soon as 72 hours after surgery. This targeted nutritional strategy could offer a more proactive way to support healing compared to traditional methods.

What evidence suggests that essential amino acid supplementation might be an effective treatment for broken bones?

Research has shown that essential amino acid (EAA) supplements can strengthen and maintain muscle health within weeks. In this trial, participants in the intervention arm will receive EAA-based oral nutrition supplementation alongside standard postoperative care. Studies have found that EAA supplements can accelerate the recovery of walking ability in individuals with broken bones. For example, one study found that EAA supplements helped elderly patients walk better after hip surgery. Another study suggested that EAA supplements can prevent muscle loss after surgery. Overall, these findings indicate that EAA supplements may aid muscle recovery and enhance physical performance after a bone fracture. ^{3 5 6 7 8}

Who Is on the Research Team?

Michael C Willey, MD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for hospital inpatients aged 65 or older who have had a low-energy femur fracture and are scheduled for surgical repair. Participants must be able to give informed consent.

Inclusion Criteria

I am currently admitted to a hospital.

I am recommended to undergo surgery to fix a part of my body.

The mechanism of injury is indicative of a low-energy event.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Preoperative

1 visit (in-person)

Treatment

Participants receive essential amino acid (EAA)-based oral nutrition supplementation or standard of care nutrition for 4 weeks post-surgery

4 weeks

Multiple visits (in-person) including Day of Surgery, Postoperative Day 1, 3-week, and 6-week clinic visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of muscle morphology and physical performance

6 months

12-week clinic visit and 6-month phone call

What Are the Treatments Tested in This Trial?

Interventions

• Essential Amino Acid Supplementation

Trial Overview The study tests if essential amino acid supplementation after surgery can help maintain muscle mass and physical performance, reduce inflammation, and promote muscle growth in patients with femoral fragility fractures.

How Is the Trial Designed?

Group I: Essential Amino Acid Supplementation Experimental Treatment 1 Intervention

Subjects randomized to intervention arm of this study will receive essential amino acid (EAA)-based oral nutrition supplementation in addition to standard of care postoperative nutrition. Subjects will take 1 scoop (26.7g) of supplement twice daily for 4 weeks after injury. Supplementation will begin within 72 hours of surgical fixation. The EAA-based supplement used in this clinical trial is MEND™ Repair and Recover®.

Group II: Standard of Care Postoperative Nutrition Active Control 1 Intervention

Subjects randomized to the control arm of this study will receive no intervention. They will receive standard of care postoperative nutrition.

Who Is Running the Clinical Trial?

Michael C Willey

Lead Sponsor

Trials

4

Recruited

730+

MEND

Collaborator

Trials

2

Recruited

150+

Slocum Research & Education Foundation

Collaborator

Trials

3

Recruited

190+

Published Research Related to This Trial

In a study involving 23 patients with moderate to severe COPD and 19 healthy older adults, free essential amino acid (EAA) supplements were found to stimulate whole body protein gain more effectively than complete protein supplements, with a 49% higher protein gain in COPD patients after EAA intake.

The results suggest that EAA supplements could be a beneficial strategy for preventing muscle wasting in COPD patients, similar to their effects observed in healthy older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of essential amino acid supplementation in stimulating whole body net protein anabolism is comparable between COPD patients and healthy older adults. Jonker, R., Deutz, NE., Erbland, ML., et al.[2019]

Essential amino acid (EAA) supplementation is crucial for stimulating muscle protein synthesis (MPS) and maintaining skeletal muscle, especially in aging or clinical populations, as it helps replace damaged muscle proteins and enhances performance.

Supplementing with free-form EAAs can effectively increase EAA levels in the body, requiring only small doses (1.5-3.0 g) to stimulate MPS, and is more effective than consuming the same amount of intact protein.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International Society of Sports Nutrition Position Stand: Effects of essential amino acid supplementation on exercise and performance. Ferrando, AA., Wolfe, RR., Hirsch, KR., et al.[2023]

Perioperative essential amino acid (EAA) supplementation significantly improved lower-limb muscle volume and strength in patients after total knee arthroplasty (TKA), with muscle area increasing by 134% in the EAA group compared to 114% in the placebo group over 2 years.

Despite the improvements in muscle recovery, EAA supplementation did not lead to significant differences in clinical outcomes such as knee pain or functional mobility between the EAA and placebo groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Essential Amino Acid Supplementation Facilitates Quadriceps Muscle Strength and Volume Recovery After TKA: A Double-Blinded Randomized Controlled Trial. Ueyama, H., Kanemoto, N., Minoda, Y., et al.[2023]

Both oral essential amino acids (EAS) and amino acid-containing dialysate (ACD) significantly improved nutritional status in peritoneal dialysis patients, as evidenced by increases in serum albumin levels after 6 months.

The study involved 45 patients (31 EAS and 14 ACD), and while both groups showed similar increases in albumin levels, the EAS group had a slightly higher increase, indicating both strategies are effective for addressing malnutrition in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of oral essential aminoacids and aminoacids containing dialysate in peritoneal dialysis. Unverdi, S., Ceri, M., Uz, E., et al.[2014]

In a study of 400 adults with pelvic and extremity fractures, those who received conditionally essential amino acid (CEAA) supplementation experienced significantly fewer complications (30.5% vs. 43.8%) compared to the control group, indicating a protective effect of CEAA against postoperative issues.

CEAA supplementation helped maintain fat-free mass (FFM) at 6 weeks post-surgery, with a decrease of only -0.33 kg in the CEAA group compared to -0.9 kg in the control group, suggesting it may prevent early muscle wasting after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conditionally Essential Amino Acid Supplementation Reduces Postoperative Complications and Muscle Wasting After Fracture Fixation: A Randomized Controlled Trial. Hendrickson, NR., Davison, J., Glass, NA., et al.[2022]

In a study of 83 elderly patients recovering from hip fracture surgery, those who received essential amino acid (EAA) supplementation alongside rehabilitation therapy showed a significantly greater improvement in walking capacity compared to those who received rehabilitation alone or with a placebo.

The results indicated that EAA supplementation (8 g/day) enhanced the recovery rate of walking ability, as measured by the 6-minute walking distance, demonstrating its potential as an effective adjunct to rehabilitation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplemented amino acids may enhance the walking recovery of elderly subjects after hip fracture surgery. Aquilani, R., Zuccarelli Ginetto, C., Rutili, C., et al.[2019]

In a study of 112 elderly patients recovering from hip fractures, those who received essential amino acids (EAAs) showed a significant reduction in hypoalbuminemia (low albumin levels) at discharge compared to those on a placebo (31.7% vs. 77.8%; p < 0.001).

While the reduction in anemia (low hemoglobin levels) was not statistically significant, EAAs led to a 34.2% reduction in anemia among patients, suggesting potential clinical benefits in improving overall health in rehabilitative elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Despite Inflammation, Supplemented Essential Amino Acids May Improve Circulating Levels of Albumin and Haemoglobin in Patients after Hip Fractures. Aquilani, R., Zuccarelli, GC., Condino, AM., et al.[2018]

In a study of 32 patients with severe COPD and sarcopenia, oral supplementation of essential amino acids (EAAs) for three months led to significant improvements in body weight (increased by 6 kg) and fat-free mass (increased by 3.6 kg), indicating enhanced nutritional status and muscle metabolism.

The EAA supplementation also resulted in improved physical activity (increased by 80%) and cognitive function (MMSE score improved from 19.1 to 20.8), suggesting that EAAs may positively impact overall health and quality of life in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive effects of supplemented essential amino acids in patients with severe COPD and sarcopenia. Dal Negro, RW., Aquilani, R., Bertacco, S., et al.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10561576/

essential amino acid supplementation on skeletal muscle and ... This document presents the position of the International Society of Sports Nutrition (ISSN) on the effect of dietary supplementation with free-form EAAs on MPS, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405457724001426

Effects of essential amino acid (EAA) and glutamine ... After just a few days or weeks of administration, supplementation with EAAs and glutamine has shown significant effects in maintaining muscle size and strength.

3. withpower.com withpower.com/trial/phase-muscular-atrophy-10-2023-4ca57

Amino Acid Supplements for Broken Bones The results indicated that EAA supplementation (8 g/day) enhanced the recovery rate of walking ability, as measured by the 6-minute walking distance, ...

4. orthopedics.medicine.uiowa.edu orthopedics.medicine.uiowa.edu/news/2024/01/can-amino-acid-supplement-improve-outcomes-patients-hip-fractures

Can an amino acid supplement improve outcomes for patients ... Previous studies have offered preliminary evidence that essential amino acid (EAA) supplementation mitigates loss of muscle mass after ...

5. grantgarciamd.com grantgarciamd.com/articles/the-role-of-amino-acid-supplementation-in-new.pdf

The Role of Amino Acid Supplementation in Orthopaedic ... Aquilani R, Zuccarelli Ginetto C, Rutili C, et al: Supplemented amino acids may enhance the walking recovery of elderly subjects after hip fracture surgery.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11713956/

Amino Acid Supplementation May Help Prevent Muscle ... We sought to investigate the effect of EAA supplementation in the perioperative period on patients undergoing orthopedic and spine surgery.

7. acfas.org acfas.org/conditionally-essential-amino-acid-supplementation-reduces-postoperative-complications-and-muscle-wa

Conditionally Essential Amino Acid Supplementation ... The results of this study show that 2 weeks of twice daily CEAA supplementation can potentially reduce early loss of muscle mass and overall complication rate.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11469702/

Efficacy of Protein and Essential Amino Acid Supplementation ... Our findings suggest that protein and/or EAA supplementation in lower limb surgeries might effectively improve PRO but does not affect mobility.