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

NCT04294563 | Terminated

• 1 other identifier: AU 20-104
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Keywords

total knee arthroplasty; physical rehabilitation; protein supplementation; muscular atrophy; inflammatory cytokines

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change in leg extensor isokinetic dynamometry

  0-6 weeks, 6-12 weeks

• Physical Function testing

  0-6 weeks, 6-12 weeks

• Physical Performance testing

  0-6 weeks, 6-12 weeks

• Oxford Knee Score

  0-6 weeks, 6-12 weeks

• Change in inflammatory biomarkers

  0-6 weeks, 6-12 weeks

Study Arms (2)

Immediate Intervention Group

EXPERIMENTAL

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; Other: Standard Care by Surgeon and Physical Therapist

Wait-llist Control Group

ACTIVE COMPARATOR

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

Interventions

Peanut Protein Powder DIETARY_SUPPLEMENT

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

Immediate Intervention Group

Standard Care by Surgeon and Physical Therapist OTHER

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

Immediate Intervention Group; Wait-llist Control Group

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• total knee arthroplasty scheduled within two weeks under the care of surgeons at the Jack Hughston Clinic

You may not qualify if:

• 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

Sponsors & Collaborators

• Auburn University: lead
• Edward Via College of Osteopathic Medicine-Auburn: collaborator
• Jack Hughston Memorial Hospital: collaborator

Study Sites (1)

Auburn University

Auburn, Alabama, 36849, United States

Location

MeSH Terms

Conditions

Muscular Atrophy

Interventions

Physical Therapists

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Randall J Ruark, MD

  Jack Hughston Memorial Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and DPD Director

Study Record Dates

• First Submitted: March 1, 2020
• First Posted: March 4, 2020
• Study Start: August 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)