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Nutritional Intervention
Nutritional Supplements for Knee Surgery Recovery
N/A
Recruiting
Led By Chris McGlory, PhD
Research Sponsored by Dr. Chris McGlory, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed anterior cruciate ligament injury requiring reconstruction surgery
Patellar tendon graft or quadriceps tendon graft reconstruction procedure
Must not have
Current use of any form of steroid or within the last 6 months
Any form of cancer currently or in the last 5 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months and 12 weeks (8 weeks post surgery), respectively.
Summary
"This trial aims to investigate whether a combination of essential amino acids and omega-3 fatty acids can help prevent muscle loss and weakness after knee surgery. The study will involve participants taking these supplements before and after
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include digestive discomfort or allergic reactions related to the supplement ingredients like omega-3 fatty acids or amino acids. However, these are generally considered safe.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need surgery for a torn ACL in my knee.
Select...
I had knee surgery using a patellar or quadriceps tendon graft.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have used steroids in the past 6 months.
Select...
I have had cancer in the past 5 years or have it now.
Select...
I have a bleeding disorder or am on blood-thinning medication.
Select...
My surgery is planned at a location not part of the research center.
Select...
My surgery is scheduled within the next 5 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months and 12 weeks (8 weeks post surgery), respectively.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months and 12 weeks (8 weeks post surgery), respectively.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of Recruitment and Retention
Secondary study objectives
Erythrocyte Phospholipid Composition
Expression of Translational Factors Related to Skeletal Muscle Protein Synthesis
Muscle Cross-Sectional Area
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nutritional InterventionExperimental Treatment1 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 ControlPlacebo Group1 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.
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Who is running the clinical trial?
Dr. Chris McGlory, PhDLead Sponsor
2 Previous Clinical Trials
48 Total Patients Enrolled
Chris McGlory, PhDPrincipal InvestigatorQueen's University
1 Previous Clinical Trials
28 Total Patients Enrolled
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