Protein Supplementation After ACL Surgery
ConditionACL Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-40
SponsorThe Methodist Hospital Research Institute
About this trial
The purpose of the study is to assess the longitudinal post-operative care effects of protein supplementation on muscle atrophy in the post-operative period following ACL reconstruction. The main outcome will be muscle size/mass as measured using dual energy x-ray absorptiometry (DEXA) scanning. The primary objective is to assess for any beneficial impact of protein supplementation, with implications of standardizing a recommended protocol for protein supplementation after ACL reconstruction.
Secondary outcomes will be to evaluate the survey data from the KOOS JR and Tampa Scale surveys, as well as functional measures recorded during physical therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects will include patients age 16 to 40 undergoing primary ACL reconstruction for an acute ACL tear with the PI or Sub-investigators
Disqualifiers
Subjects will not be included if they meet one of the following criteria
History of meniscectomy or meniscus repair
Obesity (BMI>35)
Diabetes
Trial design
Design model
Parallel
Treatments tested in this trial
Whey protein isolate
Dietary supplement25g of whey protein isolate
Protein + BAA
Dietary supplement* Protein drink - 25g of whey protein isolate * Amino Acid Blend - 7g of protein (4g Leucine, 1g iso leucine, 1g valine, 1g arginine)
Placebo
Dietary supplement• isocaloric-matched (25g) maltodextrin supplement
Treatment groups
102 Participants
are divided into 3 treatment groupsGroup A: Protein Supplement GroupExperimental treatment 1 intervention
Group B: Protein + Amino Acid Supplement GroupExperimental treatment 2 interventions
Group C: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Muscle mass
Lean mass in the effected limb
Time frame
Pre-operation, 4, 8 and 12 weeks post-operationSecondary outcomes
1
Patient Reported Outcomes
Knee injury and osteoarthritis outcome score (KOOS) JR Survey - This is a survey regarding pain and stiffness in the knee. Scales range from 1 (none) to 5 (extreme)
Time frame
Pre-operation 4, 8 and 12 weeks post-operation2
Patient Reported Outcomes
Tampa Scale Survey - This is a patient perception scale of injury from a scale from 1 strongly disagree to 4 strongly agree.
Time frame
Pre-operation 4, 8 and 12 weeks post-operationSponsors and contacts
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Source ClinicalTrials.gov