Peanut Protein Supplementation to Prevent Muscle Atrophy and Improve Recovery Following Total Knee Arthroplasty

Sponsor

Auburn University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04294563

Collaborator

Edward Via College of Osteopathic Medicine-Auburn (Other), Jack Hughston Memorial Hospital (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery	Dietary Supplement: Peanut Protein Powder Other: Standard Care by Surgeon and Physical Therapist	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Peanut Protein Supplementation to Prevent Muscle Atrophy and Improve Recovery Following Total Knee Arthroplasty

Actual Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Immediate Intervention Group 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.	Dietary Supplement: Peanut Protein Powder Peanut protein powder will be provided to participants who will be instructed to consume 72g daily, mixed with water Other: Standard Care by Surgeon and Physical Therapist Patient will receive standard care from treating physicians and physical therapists pre- and post-operatively
Active Comparator: Wait-llist Control Group 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.	Other: Standard Care by Surgeon and Physical Therapist Patient will receive standard care from treating physicians and physical therapists pre- and post-operatively

Arm

Intervention/Treatment

Experimental: Immediate Intervention Group

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.

Dietary Supplement: Peanut Protein Powder

Peanut protein powder will be provided to participants who will be instructed to consume 72g daily, mixed with water

Other: Standard Care by Surgeon and Physical Therapist

Patient will receive standard care from treating physicians and physical therapists pre- and post-operatively

Active Comparator: Wait-llist Control Group

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.

Other: Standard Care by Surgeon and Physical Therapist

Patient will receive standard care from treating physicians and physical therapists pre- and post-operatively

Outcome Measures

Primary Outcome Measures

Change in mid-thigh skeletal muscle area [0-6 weeks, 6-12 weeks]
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 [0-6 weeks, 6-12 weeks]
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 [0-6 weeks, 6-12 weeks]
maximal isokinetic right leg extensions on an isokinetic dynamometer (BioDex)
Physical Function testing [0-6 weeks, 6-12 weeks]
3 meter up and go test
Physical Performance testing [0-6 weeks, 6-12 weeks]
2 minute walk test
Oxford Knee Score [0-6 weeks, 6-12 weeks]
12 question inventory
Change in inflammatory biomarkers [0-6 weeks, 6-12 weeks]
serum C-reactive protein, interleukin-6, tumor necrosis factor-alpha, plasma 8-hydroxy-2'deoxyguanosine

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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