SurgeryNCT04294563
Peanut Protein Supplementation to Prevent Muscle Atrophy and Improve Recovery Following Total Knee Arthroplasty
A study testing Peanut Protein Powder in people with Surgery, run by Auburn University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- Peanut Protein Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- total knee arthroplasty scheduled within two weeks under the care of surgeons at the Jack Hughston Clinic
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Surgery
- Being tested
- Peanut Protein Powder, Standard Care by Surgeon and Physical Therapist
- Keywords
- total knee arthroplasty, physical rehabilitation, protein supplementation, muscular atrophy, inflammatory cytokines
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut Protein PowderDietary supplement
Peanut protein powder will be provided to participants who will be instructed to consume 72g daily, mixed with water
Standard Care by Surgeon and Physical TherapistOther
Patient will receive standard care from treating physicians and physical therapists pre- and post-operatively
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Care by Surgeon and Physical Therapist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 0-6 weeks, 6-12 weeks
Secondary outcomes (5)
Change in leg extensor isokinetic dynamometry
maximal isokinetic right leg extensions on an isokinetic dynamometer (BioDex)
Measured: 0-6 weeks, 6-12 weeks
Physical Function testing
3 meter up and go test
Measured: 0-6 weeks, 6-12 weeks
Physical Performance testing
2 minute walk test
Measured: 0-6 weeks, 6-12 weeks
Oxford Knee Score
12 question inventory
Measured: 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
Measured: 0-6 weeks, 6-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start1 Aug 2021
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Why it stopped: Accrual targets not met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Collaborators
- Edward Via College of Osteopathic Medicine-Auburn, Jack Hughston Memorial Hospital
- Responsible party
- Principal investigator, Andrew Fruge, Auburn University
- Investigators
- Randall J Ruark, MD, Study chair, Jack Hughston Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294563
- Sponsor's protocol ID
- AU 20-104
- Status last verified
- Apr 2023
- First submitted
- 1 Mar 2020
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peanut Protein Supplementation to Prevent Muscle Atrophy and Improve Recovery Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04294563
- Acronym / sponsor ID
- AU 20-104
- Conditions
- Surgery
- Keywords
- total knee arthroplasty, physical rehabilitation, protein supplementation, muscular atrophy, inflammatory cytokines
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Accrual targets not met
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Collaborators
- Edward Via College of Osteopathic Medicine-Auburn, Jack Hughston Memorial Hospital
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 4 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention Group | Experimental | Dietary Supplement: Peanut Protein Powder, Other: Standard Care by Surgeon and Physical TherapistParticipants 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. |
| Wait-llist Control Group | Active comparator | Other: Standard Care by Surgeon and Physical TherapistParticipants 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. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- total knee arthroplasty scheduled within two weeks under the care of surgeons at the Jack Hughston Clinic
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peanut Protein PowderPeanut protein powder will be provided to participants who will be instructed to consume 72g daily, mixed with water | Dietary supplement | Immediate Intervention Group |
| Standard Care by Surgeon and Physical TherapistPatient will receive standard care from treating physicians and physical therapists pre- and post-operatively | Other | Immediate Intervention Group, Wait-llist Control Group |
Primary outcome
Change in mid-thigh skeletal muscle area
Time frame: 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
Time frame: 0-6 weeks, 6-12 weeks
peripheral quantitative computed tomography (pQCT) cross-sectional image of mid-right thigh assessed for overall muscle density
5 secondary outcomes
Change in leg extensor isokinetic dynamometry
Time frame: 0-6 weeks, 6-12 weeks
Physical Function testing
Time frame: 0-6 weeks, 6-12 weeks
Physical Performance testing
Time frame: 0-6 weeks, 6-12 weeks
Oxford Knee Score
Time frame: 0-6 weeks, 6-12 weeks
Change in inflammatory biomarkers
Time frame: 0-6 weeks, 6-12 weeks
Results and safety
The study was stopped early (reason given: Accrual targets not met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randall J Ruark, MD study chair
Jack Hughston Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peanut Protein Powder in people with Surgery, run by Auburn University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Accrual targets not met). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mid-thigh skeletal muscle area (time frame: 0-6 weeks, 6-12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.