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

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.

Study Overview

• Status: Terminated
• Conditions: Surgery
• Intervention / Treatment: Dietary supplement: Peanut Protein Powder; Other: Standard Care by Surgeon and Physical Therapist

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Auburn, Alabama, United States, 36849
      • Auburn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	0-6 weeks, 6-12 weeks
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	0-6 weeks, 6-12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in leg extensor isokinetic dynamometry	maximal isokinetic right leg extensions on an isokinetic dynamometer (BioDex)	0-6 weeks, 6-12 weeks
Physical Function testing	3 meter up and go test	0-6 weeks, 6-12 weeks
Physical Performance testing	2 minute walk test	0-6 weeks, 6-12 weeks
Oxford Knee Score	12 question inventory	0-6 weeks, 6-12 weeks
Change in inflammatory biomarkers	serum C-reactive protein, interleukin-6, tumor necrosis factor-alpha, plasma 8-hydroxy-2'deoxyguanosine	0-6 weeks, 6-12 weeks

Collaborators and Investigators

• Sponsor: Auburn University
• Collaborators: Edward Via College of Osteopathic Medicine-Auburn; Jack Hughston Memorial Hospital
• Investigators: Study Chair: Randall J Ruark, MD, Jack Hughston Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: March 1, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: total knee arthroplasty; protein supplementation; inflammatory cytokines; physical rehabilitation; muscular atrophy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy
• Other Study ID Numbers: AU 20-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No