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

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 Essential Amino Acid Supplementation for broken bones?

Research shows that essential amino acid supplements can help improve walking recovery and increase protein levels in the blood for elderly patients after hip fractures. This suggests that these supplements might also support recovery in other types of bone injuries. ^{1 2 3 4 5}

How do amino acid supplements for broken bones differ from other treatments?

Amino acid supplements for broken bones are unique because they focus on enhancing muscle recovery and strength, which can aid in rehabilitation after fractures. Unlike traditional treatments that may focus solely on bone healing, these supplements help improve walking capacity and muscle function, particularly in elderly patients recovering from surgeries like hip fractures. ^{1 2 6 7 8}

What is the purpose of this trial?

This trial will evaluate the impact of 4 weeks of postoperative essential amino acid (EAA)-based supplementation on muscle morphology after femoral fragility fracture. This trial will assess the ability of EAA-based to increase skeletal muscle metabolic activity, reduce inflammation, and induce muscle fiber hypertrophy, as well as preserve skeletal muscle mass and physical performance up to 6 months after injury. Participants will be randomized in a 1:1 ratio to 1) standard of care (no dietary intervention) or 2) EAA-based supplementation.

Research Team

Michael C Willey, MD

Principal Investigator

University of Iowa

Eligibility Criteria

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.

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Supplemented amino acids may enhance the walking recovery of elderly subjects after hip fracture surgery. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Despite Inflammation, Supplemented Essential Amino Acids May Improve Circulating Levels of Albumin and Haemoglobin in Patients after Hip Fractures. [2018]

4. Italy pubmed.ncbi.nlm.nih.gov

Comprehensive effects of supplemented essential amino acids in patients with severe COPD and sarcopenia. [2016]

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

Conditionally Essential Amino Acid Supplementation Reduces Postoperative Complications and Muscle Wasting After Fracture Fixation: A Randomized Controlled Trial. [2022]

6. United States 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. [2023]

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

International Society of Sports Nutrition Position Stand: Effects of essential amino acid supplementation on exercise and performance. [2023]

8. England pubmed.ncbi.nlm.nih.gov

The effectiveness of oral essential aminoacids and aminoacids containing dialysate in peritoneal dialysis. [2014]