Dietary Protein Intake and Rehabilitation From Anterior Cruciate Ligament Surgery
NCT ID: NCT03614351
Last Updated: 2021-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-10-31
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Physical Therapy plus Protein Supplement
Participants will be randomized to the protein supplementation group, PROT, and will receive education from a dietary counselor on how to monitor protein intake using a smartphone app.
Protein (PROT)
Participants will receive Combat Protein Powder made by MusclePharm in an amount sufficient to take 80g daily until their next visit. They will be encouraged to ingest 40 g after exercise and 40 g before bed which will partly comprise their daily goal. They will be educated on the concept of complete high quality proteins, and that some proteins can facilitate muscle growth greater than others. Additionally, they will receive meal plan ideas and shopping tips that will facilitate healthy and economical protein consumption up to or beyond their daily goal.
Physical Therapy Control
Participants will be randomized to the enhanced-care control group, CONT, and will receive education from a dietary counselor on how to monitor protein intake using a smartphone app.
Control (CONT)
Instructed not to alter their diet based on the app, and to continue to eat as they normally would.
Interventions
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Protein (PROT)
Participants will receive Combat Protein Powder made by MusclePharm in an amount sufficient to take 80g daily until their next visit. They will be encouraged to ingest 40 g after exercise and 40 g before bed which will partly comprise their daily goal. They will be educated on the concept of complete high quality proteins, and that some proteins can facilitate muscle growth greater than others. Additionally, they will receive meal plan ideas and shopping tips that will facilitate healthy and economical protein consumption up to or beyond their daily goal.
Control (CONT)
Instructed not to alter their diet based on the app, and to continue to eat as they normally would.
Eligibility Criteria
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Inclusion Criteria
* Subjects must have a smartphone capable of running the nutrition tracking app (My Fitness Pal)
Exclusion Criteria
* They must not have had a concurrent meniscal repair (debridement is acceptable).
* They must not have post-operative limitations that interfere with rehabilitation.
* Patients determined by the referring surgeon to be poor candidates for the study for any medical (including history of eating disorder, phenylketonuria, maple syrup urine disease, food allergies, lactose intolerance, kidney or liver disease) or other reasons that deem them inappropriate to complete the intervention (driving distance from facility, work schedule that prohibits therapy treatments, dietary restrictions) will be excluded.
* Females who are pregnant will not be permitted in the study.
16 Years
ALL
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Gary Miller, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
References
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Other Identifiers
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IRB00046590
Identifier Type: -
Identifier Source: org_study_id
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