AzTrials
AzTrials

Anterior Cruciate Ligament ReconstructionNCT06233825

Nutritional Intervention to Enhance Recovery After Arthroscopic Knee Surgery in Adults

A study testing Omega-3 Fatty Acids and Essential Amino Acids and Safflower Oil and Non-Essential Amino Acids in people with Anterior Cruciate Ligament Reconstruction and Muscular Atrophy, run by Dr. Chris McGlory, PhD at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Loss of skeletal muscle mass (atrophy) and strength in the lower limb are consequences of elective knee surgery as result of prolonged disuse from limb immobilization and impaired mobility, as well as pathophysiological trauma. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Omega-3 Fatty Acids and Essential Amino Acids and Safflower Oil and Non-Essential Amino Acids
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteCanada
Study dates
1 Feb 2024to 14 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Diagnosed anterior cruciate ligament injury requiring reconstruction surgery
  • Surgery in Kingston, ON
  • Patellar tendon graft, quadriceps tendon graft, or hamstring tendon graft reconstruction procedure

Who cannot join

  • Any muscular, neurological, respiratory, or metabolic disease, subject to investigators' discernment, would negatively affect the subject's ability to comply with the study requirements
  • Any form of cancer currently or in the last 5 years
  • Bleeding disorders or antiplatelet / anticoagulation therapy
  • Currently taking fish oils or within the last 6 months
  • Regular consumption (≥ 2x week) of fish oil or oily fish in the last 6 months
  • Allergy or sensitivity to fish, shellfish or safflower oils
Show all 13Show fewer
  • Currently taking any form of steroid or within the last 6 months
  • Medical inability to attain magnetic resonance imaging scans
  • Known irregular responses to physical activity (e.g., shortness of breath, chest pain, dizziness, etc.)
  • Surgery scheduled outside of research centre
  • Scheduled surgery date < 5 weeks away
  • Pregnant or plans to become pregnant within the next 6 months
  • Any current illness that impacts ability to participate in protocols

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Queen's University

    Kingston, Ontario, K7L 3N6

Other trials in Canada

About this study

Official title: Nutritional Intervention to Enhance Recovery After Arthroscopic Knee Surgery in Adults: A Randomized Controlled Pilot Trial

Loss of skeletal muscle mass (atrophy) and strength in the lower limb are consequences of elective knee surgery as result of prolonged disuse from limb immobilization and impaired mobility, as well as pathophysiological trauma. The highest rates of skeletal muscle mass and strength loss occur during the 2-week post-surgery period, considered the early phase of outpatient recovery. Alternative to resistance exercise and pharmacology, nutritional intervention represents one strategy to combat skeletal muscle disuse atrophy.

Essential amino acids (EAA) and omega-3 fatty acids are known to independently potentiate rates of skeletal muscle protein synthesis and attenuate skeletal muscle atrophy in humans. However, the combined actions these nutritional strategies on skeletal muscle have not been explored in a pathophysiological context, such as surgery. With the ultimate goal to test the efficacy of the combined nutritional strategy to attenuate skeletal muscle disuse atrophy in the future, the aim of this present pilot study is to explore the feasibility of recruitment and retention of anterior cruciate ligament reconstruction (ACLR) outpatients from a single centre across 18 months for a 6-week nutritional intervention. Participants will consume either an intervention of omega-3 fatty acids and EAAs, or a placebo control of safflower oil and non-essential amino acids (NEAA), for 4 weeks before and 2 weeks after elective ACLR surgery. Furthermore, this pilot will characterize secondary outcomes of skeletal muscle mass, strength, and power, and integrated rates of muscle protein synthesis, as well as report participant adherence to protocols and incidence of adverse events.

Read the detailed description

Over their lifespan, many individuals experience episodes of skeletal muscle-disuse due to illness, injury, or elective surgery. Periods of prolonged skeletal muscle disuse, such after ACLR, result in the loss of skeletal muscle mass (atrophy) and strength. Skeletal muscle disuse precipitates several metabolic and functional impairments. Importantly, as the Canadian health care system shifts towards day surgeries and outpatient settings as opposed to in-hospital care, the development of patient-led strategies to mitigate skeletal muscle disuse atrophy has become increasingly vital.

For most ACLR outpatients, resistance exercise is not feasible in the immediate 2-week post-surgical period, during which the rates of skeletal muscle mass and strength loss are highest. Outside of pharmacology, nutrition represents one alternative strategy to combat skeletal muscle-disuse atrophy during this time. Previous work reported that daily supplementation with EAA prior to and after total knee arthroplasty surgery attenuated skeletal muscle atrophy and enhanced recovery of functional mobility in adults. Similarly, chronic daily supplementation with omega-3 fatty acids reduced declines in quadriceps volume in healthy, young women during single-leg immobilization. This finding complemented previous work in which supplementation with omega-3 fatty acids potentiated muscle protein synthesis rates in response to an hyperaminoacidemic-hyperinsulinemic clamp, but not fasting rates in healthy younger, middle-aged, and older adults, while it additionally improved skeletal muscle strength and power. Together, these data suggest that combined intake of omega-3 fatty acids and EAAs may be an effective strategy to combat skeletal muscle-disuse atrophy, and perhaps loss of skeletal muscle strength, in response to ACLR.

Whilst there is a growing body of literature to promote EAA and omega-3 fatty acids as anabolic stimuli, no work has explored the combined effect of these nutritional strategies in the pathophysiological context of surgery. Nutritional strategies represent an accessible treatment for skeletal muscle disuse atrophy that is independent of patient age, mobility, or current health status, which could prove favourable for surgical outpatients, as well as individuals experiencing periods of prolonged immobilization or bed rest. The future goal of this design is to test efficacy of the combined nutritional strategy of daily omega-3 fatty acid and EAA supplementation to attenuate of skeletal muscle disuse atrophy following elective knee surgery. However, the aim of the present randomized controlled pilot trial is to explore the feasibility of recruitment and retention of adult ACLR outpatients from a single centre across 18 months for a protocol that prescribes combination omega-3 fatty acid and EAA supplementation vs. a calorie- and nitrogen-matched placebo control supplement 4 weeks before and 2 weeks after ACLR surgery. This pilot will also characterize measurements of skeletal muscle volume, strength, and function, and integrated rates of skeletal muscle protein synthesis, as well as report participant adherence to protocols and the incidence of adverse events. The investigators envisage that the data generated from this trial will be used to inform the future large scale randomized controlled trial (RCT) that will examine the effect of the combined nutritional intervention on skeletal muscle volume and functional outcomes in response to ACLR. The results of future work may inform clinical practice and outpatient care guidelines to minimize loss of skeletal muscle mass and strength in response to elective surgery.

Being tested
Omega-3 Fatty Acids and Essential Amino Acids, Safflower Oil and Non-Essential Amino Acids
Keywords
omega-3 fatty acids, fish oil, eicosapentaenoic acid, docosahexaenoic acid, skeletal muscle, anterior cruciate ligament, essential amino acids, magnetic resonance imaging, muscle protein synthesis
Medical subject headings
Muscular Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omega-3 Fatty Acids and Essential Amino AcidsDietary supplement

    Also called Fish Oil

    Oil consumed as capsules. EAA come as powder to be mixed with water before drinking. 4 g of leucine per EAA dose.

  • Safflower Oil and Non-Essential Amino AcidsDietary supplement

    Oil consumed as capsules. NEAA are isonitrogenous to intervention condition. Both supplement types are isoenergetic to intervention. NEAA come as powder to be mixed with water before drinking.

Study groups in NCT06233825
Study groupRoleWhat they receive
Nutritional InterventionExperimental5 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.
Receives: Dietary Supplement: Omega-3 Fatty Acids and Essential Amino Acids
Placebo ControlPlacebo comparator5 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.
Receives: Dietary Supplement: Safflower Oil and Non-Essential Amino Acids

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Recruitment and Retention

    Number of participants recruited and retained. Criteria for success is 30 outpatients recruited and at least 22 retained.

    Measured: 18 months and 12 weeks (8 weeks post surgery), respectively.

Secondary outcomes (10)
  1. Muscle Mass

    Change in quadriceps muscle mass measured by magnetic resonance imaging scan.

    Measured: 0 and 2 weeks

  2. Muscle Cross-Sectional Area

    Change in quadriceps muscle cross sectional area measured by magnetic resonance imaging scan.

    Measured: 0 and 2 weeks

  3. Muscle Protein Synthesis

    Muscle protein synthesis measured as fractional synthesis rate using combined protocol of skeletal muscle biopsy, stable isotope tracing, cavity ring down spectroscopy with liquid isotope analysis, and gas-chromatography pyrolysis isotope-ratio mass spectrometry.

    Measured: -1 to 0 weeks and 0 to 2 weeks.

  4. Skeletal Muscle Phospholipid Composition

    Phospholipid composition will be assessed by gas chromatography.

    Measured: -4 and 2 weeks.

  5. Erythrocyte Phospholipid Composition

    Phospholipid composition will be assessed by gas chromatography.

    Measured: -4 and 2 weeks.

  6. Plasma Proteomics

    Change in target signal intensity and protein concentration measured through proteome profiling by aptamer based SOMAscan assay.

    Measured: -4, 0 and 2 weeks.

  7. Expression of Translational Factors Related to Skeletal Muscle Protein Synthesis

    Activation of translational factors involved in skeletal muscle protein synthesis assessed by western blotting.

    Measured: -4, 0 and 2 weeks.

  8. Muscle Function

    Stair climb power test performance.

    Measured: -4 and 8 weeks.

  9. Muscle Strength

    Knee-extensor peak torque measured by dynamometry.

    Measured: -4 and 8 weeks.

  10. Muscle Power

    Isotonic power measured by dynamometry.

    Measured: -4 and 8 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2024
  2. Study start1 Feb 2024
  3. Primary completion1 Aug 2025
  4. Study completion14 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled feasibility pilot trial.Two-arm study. Half of participants are allocated to the nutritional intervention condition (5 g omega-3, 40 g essential amino acids \[EAA\] per day), and half to the placebo control condition (5 g safflower oil, 40 g non-essential amino acids \[NEAA\] per day).
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06233825
Sponsor's protocol ID
6038901
Status last verified
Aug 2025
First submitted
19 Jan 2024
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nyman DLE, Pufahl CJ, Hickey OGV, Stokes T, Simpson CA, Selinger JC, Mathur S, Janssen I, Giangregorio LM, Bardana DD, McGlory C. Nutritional intervention to enhance recovery after arthroscopic knee surgery in adults: a randomized controlled pilot trial. Pilot Feasibility Stud. 2024 Nov 12;10(1):138. doi: 10.1186/s40814-024-01561-w.

    PubMed 39533408

Questions about this trial

What is this clinical trial studying?

A study testing Omega-3 Fatty Acids and Essential Amino Acids and Safflower Oil and Non-Essential Amino Acids in people with Anterior Cruciate Ligament Reconstruction and Muscular Atrophy, run by Dr. Chris McGlory, PhD at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Recruitment and Retention (time frame: 18 months and 12 weeks (8 weeks post surgery), respectively.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06233825, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in