Nutritional Supplements for Knee Surgery Recovery

Overseen By Danielle Nyman, PhD(c)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Chris McGlory, PhD

Must not be taking: Fish oils, Steroids

Disqualifiers: Cancer, Bleeding disorders, Pregnancy, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether omega-3 fatty acids and essential amino acids (EAAs) can reduce muscle loss after knee surgery. It seeks to determine if this nutritional approach could serve as an alternative to exercises and drugs for those recovering from anterior cruciate ligament (ACL) surgery. Participants will receive either the nutritional supplements or a placebo to assess differences in muscle strength and recovery. Individuals with an ACL injury scheduled for surgery in Kingston, ON, who are not currently taking fish oils or steroids, may be suitable for this study. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance recovery options for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking fish oils, steroids, or certain blood thinners. It's best to discuss your specific medications with the trial team.

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

Research shows that omega-3 fatty acids and essential amino acids (EAAs) can help prevent muscle loss by supporting muscle growth. Studies have found these nutrients to be generally safe and well-tolerated in healthy individuals. When taken as supplements, omega-3 fatty acids have been linked to improved muscle strength and size.

Omega-3 fatty acids are usually safe at research doses, though some people might experience mild side effects like an upset stomach or a fishy aftertaste. EAAs are also safe for most individuals and are a normal part of the diet, aiding in protein building.

Overall, combining omega-3 fatty acids and EAAs appears promising for muscle health and is considered safe based on current research. However, consulting a healthcare provider before starting any new supplement is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using omega-3 fatty acids and essential amino acids for knee surgery recovery because these supplements target inflammation and muscle repair, unlike traditional pain medications and physical therapy. Omega-3s, particularly EPA and DHA, are known for their anti-inflammatory properties, which can help reduce swelling and pain post-surgery. Essential amino acids (EAAs) support muscle protein synthesis, potentially speeding up recovery and improving muscle strength. This dual approach addresses both inflammation and muscle healing, offering a comprehensive alternative to conventional treatments.

What evidence suggests that this trial's nutritional supplements could be effective for knee surgery recovery?

This trial will compare the effects of a nutritional intervention with a placebo control on knee surgery recovery. Participants in the nutritional intervention arm will receive omega-3 fatty acids and essential amino acids (EAAs). Studies have shown that EAAs and omega-3 fatty acids can each help slow muscle loss in healthy individuals. Research indicates that taking EAAs before and after knee surgery can reduce muscle loss and aid recovery. Omega-3s have also been found to lessen arthritis pain and protect joints, potentially aiding recovery. Although specific data on using these supplements together for surgery recovery is not yet available, their individual benefits suggest they might work well together to help maintain muscle after surgery. ^{1 6 7 8 9}

Who Is on the Research Team?

Chris McGlory, PhD

Principal Investigator

Queen's University

Are You a Good Fit for This Trial?

This trial is for adults with a diagnosed anterior cruciate ligament injury who are scheduled for reconstruction surgery using patellar or quadriceps tendon grafts in Kingston, ON. It's designed to see if certain nutritional supplements can help prevent muscle loss after knee surgery.

Inclusion Criteria

I need surgery for a torn ACL in my knee.

My surgery will be in Kingston, ON.

I had knee surgery using a patellar or quadriceps tendon graft.

Exclusion Criteria

I do not have any illnesses that prevent me from following study procedures.

Pregnant or plans to become pregnant within the next 6 months

I do not have any health conditions that would stop me from following the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Nutritional Intervention

Participants receive omega-3 fatty acids and EAAs or placebo for 4 weeks before surgery

4 weeks

1 visit (in-person) for baseline measurements

Post-Surgery Nutritional Intervention

Participants continue receiving omega-3 fatty acids and EAAs or placebo for 2 weeks after surgery

2 weeks

1 visit (in-person) for post-surgery assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

2 visits (in-person) for follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• Omega-3 Fatty Acids and Essential Amino Acids

Trial Overview

The study tests whether taking omega-3 fatty acids and essential amino acids can reduce muscle atrophy compared to a control group taking safflower oil and non-essential amino acids. Participants will start the supplements 4 weeks before surgery and continue for 2 weeks after.

How Is the Trial Designed?

Group I: Nutritional Intervention Experimental Treatment 1 Intervention

5 g omega-3 fatty acids (3.75 g eicosapentaenoic acid \[EPA\] + 1.25 g docosahexaenoic acid \[DHA\]) per day for 6 weeks, starting 4 weeks before and continuing 2 weeks after surgery, plus 40 g (2 x 20 g) of EAA per day, starting 1 week before and continuing 2 weeks after surgery.

Group II: Placebo Control Placebo Group 1 Intervention

5 g safflower oil per day for 6 weeks, starting 4 weeks before and continuing 2 weeks after surgery, plus 40 g (2 x 20 g) of NEAA per day, starting 1 week before and continuing 2 weeks after surgery.

Omega-3 Fatty Acids and Essential Amino Acids is already approved in United States, European Union for the following indications:

Approved in United States as Omega-3 fatty acids for:

• Hypertriglyceridemia
• Cardiovascular health

Approved in European Union as Omega-3 fatty acids for:

• Hypertriglyceridemia
• Cardiovascular health
• Inflammation

Approved in United States as Essential Amino Acids for:

• Nutritional supplement
• Muscle recovery

Approved in European Union as Essential Amino Acids for:

• Nutritional supplement
• Muscle recovery
• Wound healing

Who Is Running the Clinical Trial?

Dr. Chris McGlory, PhD

Lead Sponsor

Trials

3

Recruited

80+

Dr. Chris McGlory, PhD

Lead Sponsor

Trials

3

Recruited

80+

Published Research Related to This Trial

Supplementation with Omega-3 fatty acids (EPA + DHA) significantly increases the Omega-3 Index (O3Ix) in red blood cells of elite athletes over 4 months, with a dose-dependent response observed in both 760 mg and 1140 mg groups.

The majority of athletes (93.1%) had low baseline O3Ix levels, and those with lower initial levels showed the greatest increase in Omega-3 content, indicating that supplementation is particularly beneficial for athletes starting with lower Omega-3 levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erythrocyte Omega-3 Fatty Acid Content in Elite Athletes in Response to Omega-3 Supplementation: A Dose-Response Pilot Study. Drobnic, F., Rueda, F., Pons, V., et al.[2020]

Prescription omega-3-acid ethyl esters (P-OM3) have been shown to be safe and effective in clinical trials, providing clear evidence for their use, unlike many dietary supplement forms of omega-3 fatty acids.

Clinical guidelines based on evidence now support the use of P-OM3, helping to clarify misconceptions and concerns about omega-3 fatty acids in medical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dispelling the myths about omega-3 fatty acids. Sadovsky, R., Collins, N., Tighe, AP., et al.[2008]

Preoperative supplementation with n-3 long-chain polyunsaturated fatty acids significantly reduced quadriceps weakness in patients after total knee arthroplasty, suggesting a beneficial effect on muscle strength recovery.

The intervention increased the beneficial eicosapentaenoic acid and docosahexaenoic acid levels relative to arachidonic acid, although it did not significantly affect oxidative stress, swelling, or pain levels post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of n-3 polyunsaturated fatty acid supplementation on quadriceps weakness immediately after total knee arthroplasty: a pilot, randomized, open-label clinical trial. Kubo, Y., Ikeya, M., Sugiyama, S., et al.[2023]

In a study involving 100 patients undergoing colon or liver surgery, the MOFA program, which included omega-3 fatty acids and glucose control, resulted in earlier flatulence but did not significantly improve the time to the first bowel movement compared to standard ERAS therapy.

The MOFA approach did not show any negative effects on coagulation or inflammation, and there were no significant differences in hospital stay or postoperative complications, suggesting that while it may have some benefits, it does not enhance recovery outcomes in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a metabolic optimized fast track concept (MOFA) on bowel function and recovery after surgery in patients undergoing elective colon or liver resection: a randomized controlled trial. Uhlig, C., Rössel, T., Denz, A., et al.[2020]

In a study of 148 patients undergoing elective colorectal cancer surgery, an n-3 fatty acid-enriched nutritional supplement significantly increased anti-inflammatory markers (LTB5 and 5-HEPE) and decreased pro-inflammatory markers (LTB4) compared to a standard supplement.

Despite these anti-inflammatory effects, the use of n-3 fatty acids did not lead to a reduction in postoperative complications, suggesting that while they may modulate immune response, they do not impact surgical recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of perioperative supplementation with omega-3 fatty acids on leukotriene B₄ and leukotriene B₅ production by stimulated neutrophils in patients with colorectal cancer: a randomized, placebo-controlled intervention trial. Sorensen, LS., Thorlacius-Ussing, O., Rasmussen, HH., et al.[2021]

In a study involving 1,398 adults with chronic knee pain, neither vitamin D nor marine Omega-3 fatty acids (n-3 FA) showed any significant effect on reducing knee pain over an average follow-up of 5.3 years.

The results indicate that supplementation with vitamin D and n-3 FA does not improve knee function or stiffness, suggesting these treatments may not be effective for managing symptoms of osteoarthritis in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Vitamin D and Marine Omega-3 Fatty Acid Supplementation on Chronic Knee Pain in Older US Adults: Results From a Randomized Trial. MacFarlane, LA., Cook, NR., Kim, E., et al.[2022]

Preoperative administration of omega-3 fatty acids did not show a significant effect on postoperative inflammatory markers (CRP, IL-6, WBC) or length of hospital stay in patients undergoing abdominal surgery, based on a meta-analysis of 13 randomized controlled trials involving 950 patients.

Although some reductions in inflammatory markers were noted, the overall results were inconclusive, suggesting that more extensive research is needed to clarify the impact of omega-3 fatty acids on postoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Omega-3 Fatty Acids on Postoperative Inflammatory Response: A Systematic Review and Meta-Analysis. Mohsen, G., Stroemer, A., Mayr, A., et al.[2023]

In a study involving 148 patients undergoing colorectal cancer surgery, an omega-3 fatty acid (n-3 FA) enriched supplement significantly increased levels of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and docosapentaenoic acid (DPA) in granulocytes compared to a standard supplement.

Despite the successful incorporation of n-3 FAs into immune cells, there was no significant difference in postoperative complications or hospital stay between the n-3 FA group and the control group, indicating that higher levels of these fatty acids did not lead to improved surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of perioperative omega-3 fatty acid supplements in elective colorectal cancer surgery. Sorensen, LS., Thorlacius-Ussing, O., Schmidt, EB., et al.[2016]

n-3 polyunsaturated fatty acids may help reduce inflammation in surgical patients by influencing inflammatory mediators and cell membrane interactions, potentially leading to better recovery outcomes.

Clinical trials suggest that n-3 fatty acids can improve key outcomes such as shorter hospital stays, fewer infections, and lower mortality rates in patients undergoing surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effects of the n-3 long-chain polyunsaturated fatty acids in surgical patients: updating the evidence. Bernabe-Garcia, M., Lopez-Alarcón, M., Blanco-Favela, F., et al.[2011]

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