Nutritional Intervention to Enhance Recovery After Arthroscopic Knee Surgery in Adults (NCT06233825) | Clinical Trial Compass
CompletedNot Applicable
Nutritional Intervention to Enhance Recovery After Arthroscopic Knee Surgery in Adults
Canada30 participantsStarted 2024-02-01
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosed anterior cruciate ligament injury requiring reconstruction surgery
* Surgery in Kingston, ON
* Patellar tendon graft, quadriceps tendon graft, or hamstring tendon graft reconstruction procedure
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of Recruitment and Retention
Timeframe: 18 months and 12 weeks (8 weeks post surgery), respectively.