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NCT03614351 Clinical Trial

Dietary Protein Intake and Rehabilitation From Anterior Cruciate Ligament Surgery

ACL Injury Clinical Trial

Official title:
The Effects of Providing Protein and Nutritional Guidance on Healing Times After ACL Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03614351
Other study ID # IRB00046590
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 2021
Est. completion date June 2022

Study information
Verified date July 2020
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Protein supplementation may promote increases in strength and hypertrophy in the context of resistance training (RT) and reduce markers of inflammation, while sufficient levels of protein are necessary for healing certain wounds and maintenance of muscle mass in a protein depleted state. Protein supplementation could be useful to improve clinical outcomes.

Description:

Protein supplementation may promote increases in strength and hypertrophy in the context of resistance training (RT) and reduce markers of inflammation, while sufficient levels of protein are necessary for healing certain wounds and maintenance of muscle mass in a protein depleted state. Despite this, no studies have investigated the role of protein provision in the context of physical therapy (PT) or musculoskeletal rehabilitation, including following surgical interventions. Survey data of Americans in the highest protein consuming age range (19-30 year old consuming 91 g/kg body weight/day), show they have an adequate protein intake to maintain nitrogen balance at baseline (85 g/kg). However, if patients under consume protein, as apparent in older adults (mean intake of 66 g/kg) these individuals will require more during times of tissue healing or could benefit with more in attempting to build back their strength through RT or PT. Thus, protein supplementation could be useful to improve clinical outcomes.

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Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• 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.
Other:
• Control (CONT)
Instructed not to alter their diet based on the app, and to continue to eat as they normally would.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wake Forest University Health Sciences

References & Publications (28)

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Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of individuals that complied with treatment/intervention Compliance among treatment group in meeting 2 g/kg protein goal as measured by protein tracking app and in protein supplements provided will be measured. up to 6 months
Primary Percentage of frequency individuals successfully used the protein tracking app Compliance in usage of protein tracking app will be recorded. The number of days they logged in and recorded their intake vs. total potential days to provide % value of diet protein compliance. up to 6 months
Primary Percentage of physical therapy visits attended by individuals Compliance in physical therapy will be recorded. up to 6 months
Primary Percentage counseling sessions attended by individuals Compliance in attending nutritional counseling sessions will be recorded. up to 6 months
Secondary Single Leg Hop Test Functional healing time based on single leg hop test. The distance the participant hopped on one leg will be recorded and measured in centimeters. This will be done three times and an average will be given. baseline and up to 6 month
Secondary Six Meter Timed Hop Test Functional healing time based six meter timed hop test. The time it took the participant to hop six meters on foot will be measured and recorded. baseline and up to 6 month
Secondary Change in strength in leg flexion and extension Strength in leg flexion and extension, as measured by Biodex machine baseline and up to 6 month
Secondary Change in muscle hypertrophy depth of vastus medialis as measured at each nutritional advising appointment with counselor via ultrasound and thigh circumference. baseline and up to 6 month
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