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

  • STATUS
    Recruiting
  • End date
    Aug 1, 2023
  • participants needed
    30
  • sponsor
    Auburn University
Updated on 1 May 2022
Accepts healthy volunteers

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.

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.

Details
Condition Surgery
Treatment Peanut Protein Powder, Standard Care by Surgeon and Physical Therapist
Clinical Study IdentifierNCT04294563
SponsorAuburn University
Last Modified on1 May 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note