Peanut Protein Supplementation to Prevent Muscle Atrophy and Improve Recovery Following Total Knee Arthroplasty
Primary Purpose
Surgery
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peanut Protein Powder
Standard Care by Surgeon and Physical Therapist
Sponsored by
About this trial
This is an interventional supportive care trial for Surgery focused on measuring total knee arthroplasty, physical rehabilitation, protein supplementation, muscular atrophy, inflammatory cytokines
Eligibility Criteria
Inclusion Criteria:
- total knee arthroplasty scheduled within two weeks under the care of surgeons at the Jack Hughston Clinic
Exclusion Criteria:
- history of invasive lower extremity surgery within the last 5 years
- allergy to peanuts or peanut products
- Body Mass Index <20 or >35 kg/m2
- currently adhering to a restrictive weight loss diet
- current or recent (within the last 2 months) steroid use
- any physical condition that interferes with performing post-surgery rehabilitation
- known peripheral vascular disease, kidney disease, liver disease, or uncontrolled endocrine disorder
- known overt cardiovascular or metabolic such as heart disease/failure or diabetes
- Radiation exposure within the last 6 months other than dental x-rays or associated with current knee treatment/diagnosis
Sites / Locations
- Auburn University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Immediate Intervention Group
Wait-llist Control Group
Arm Description
Participants will complete baseline measures and begin daily supplementation of peanut protein powder (72g/day) 7 days prior to total knee arthroplasty until 6 weeks after surgery.
Participants will complete baseline measures 7 days prior to total knee arthroplasty and will receive a 7 week supply after completion of 12 week post-surgery visit.
Outcomes
Primary Outcome Measures
Change in mid-thigh skeletal muscle area
peripheral quantitative computed tomography (pQCT) cross-sectional image of mid-right thigh assessed for total muscle cross-sectional area
Change in mid-thigh skeletal muscle area and quality
peripheral quantitative computed tomography (pQCT) cross-sectional image of mid-right thigh assessed for overall muscle density
Secondary Outcome Measures
Change in leg extensor isokinetic dynamometry
maximal isokinetic right leg extensions on an isokinetic dynamometer (BioDex)
Physical Function testing
3 meter up and go test
Physical Performance testing
2 minute walk test
Oxford Knee Score
12 question inventory
Change in inflammatory biomarkers
serum C-reactive protein, interleukin-6, tumor necrosis factor-alpha, plasma 8-hydroxy-2'deoxyguanosine
Full Information
NCT ID
NCT04294563
First Posted
March 1, 2020
Last Updated
April 19, 2023
Sponsor
Auburn University
Collaborators
Edward Via College of Osteopathic Medicine-Auburn, Jack Hughston Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04294563
Brief Title
Peanut Protein Supplementation to Prevent Muscle Atrophy and Improve Recovery Following Total Knee Arthroplasty
Official Title
Peanut Protein Supplementation to Prevent Muscle Atrophy and Improve Recovery Following Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Accrual targets not met
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Auburn University
Collaborators
Edward Via College of Osteopathic Medicine-Auburn, Jack Hughston Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This randomized controlled trial will study the effects of peanut protein supplementation on changes in muscle size and quality in patients undergoing total knee arthroplasty.
Detailed Description
Total knee arthroplasty (TKA) is an effective treatment for patients with knee osteoarthritis (OA) accompanied by severe pain and functional limitations. With the success of this treatment and increasing incidence of OA, it has been projected that ~3.5 million older adults will undergo TKA annually by the year 2030. While TKA is effective for reducing pain and improving health-related quality of life, TKA patients experience significant skeletal muscle atrophy and weakness in the surgical leg following surgery which, long-term, can compromise balance, functional mobility and increase fall risk. Thus, interventions to mitigate muscle atrophy and weakness post-surgery are essential to improving long-term outcomes in patients undergoing TKA.
This randomized controlled trial will study the effects of peanut protein supplementation on changes in muscle size and quality in patients undergoing total knee arthroplasty. Patients (n=30) between the ages of 60-75 years scheduled to undergo total knee arthroplasty at the Jack Hughston clinic/hospital will be recruited to participate. Participants will be stratified by gender and randomized to a peanut protein (PP) supplementation (72g daily, n=15) or waitlist control (standard care with no PP, n=15) group who will be provided with PP following the intervention. Participants in the PP group will consume PP daily starting 7 days prior to surgery and for 6 weeks post-surgery. Participants will be monitored for changes in muscle size and quality (peripheral quantitative computed tomography), upper-leg strength (isokinetic dynamometry), knee range of motion (ROM; goniometry), pain (questionnaire and pressure algometry), and functional mobility outcomes (questionnaire, timed up and go, 2-min walk test) prior to surgery and at 6 and 12-weeks post-surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery
Keywords
total knee arthroplasty, physical rehabilitation, protein supplementation, muscular atrophy, inflammatory cytokines
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate Intervention Group
Arm Type
Experimental
Arm Description
Participants will complete baseline measures and begin daily supplementation of peanut protein powder (72g/day) 7 days prior to total knee arthroplasty until 6 weeks after surgery.
Arm Title
Wait-llist Control Group
Arm Type
Active Comparator
Arm Description
Participants will complete baseline measures 7 days prior to total knee arthroplasty and will receive a 7 week supply after completion of 12 week post-surgery visit.
Intervention Type
Dietary Supplement
Intervention Name(s)
Peanut Protein Powder
Intervention Description
Peanut protein powder will be provided to participants who will be instructed to consume 72g daily, mixed with water
Intervention Type
Other
Intervention Name(s)
Standard Care by Surgeon and Physical Therapist
Intervention Description
Patient will receive standard care from treating physicians and physical therapists pre- and post-operatively
Primary Outcome Measure Information:
Title
Change in mid-thigh skeletal muscle area
Description
peripheral quantitative computed tomography (pQCT) cross-sectional image of mid-right thigh assessed for total muscle cross-sectional area
Time Frame
0-6 weeks, 6-12 weeks
Title
Change in mid-thigh skeletal muscle area and quality
Description
peripheral quantitative computed tomography (pQCT) cross-sectional image of mid-right thigh assessed for overall muscle density
Time Frame
0-6 weeks, 6-12 weeks
Secondary Outcome Measure Information:
Title
Change in leg extensor isokinetic dynamometry
Description
maximal isokinetic right leg extensions on an isokinetic dynamometer (BioDex)
Time Frame
0-6 weeks, 6-12 weeks
Title
Physical Function testing
Description
3 meter up and go test
Time Frame
0-6 weeks, 6-12 weeks
Title
Physical Performance testing
Description
2 minute walk test
Time Frame
0-6 weeks, 6-12 weeks
Title
Oxford Knee Score
Description
12 question inventory
Time Frame
0-6 weeks, 6-12 weeks
Title
Change in inflammatory biomarkers
Description
serum C-reactive protein, interleukin-6, tumor necrosis factor-alpha, plasma 8-hydroxy-2'deoxyguanosine
Time Frame
0-6 weeks, 6-12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
total knee arthroplasty scheduled within two weeks under the care of surgeons at the Jack Hughston Clinic
Exclusion Criteria:
history of invasive lower extremity surgery within the last 5 years
allergy to peanuts or peanut products
Body Mass Index <20 or >35 kg/m2
currently adhering to a restrictive weight loss diet
current or recent (within the last 2 months) steroid use
any physical condition that interferes with performing post-surgery rehabilitation
known peripheral vascular disease, kidney disease, liver disease, or uncontrolled endocrine disorder
known overt cardiovascular or metabolic such as heart disease/failure or diabetes
Radiation exposure within the last 6 months other than dental x-rays or associated with current knee treatment/diagnosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall J Ruark, MD
Organizational Affiliation
Jack Hughston Memorial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Auburn University
City
Auburn
State/Province
Alabama
ZIP/Postal Code
36849
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Peanut Protein Supplementation to Prevent Muscle Atrophy and Improve Recovery Following Total Knee Arthroplasty
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