ACL ReconstructionNCT06311058
Protein Supplementation After ACL Surgery
A study testing Whey protein isolate and Protein + BAA in people with ACL Reconstruction, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
The purpose of the study is to assess the longitudinal post-operative care effects of protein supplementation on muscle atrophy in the post-operative period following ACL reconstruction. The main outcome will be muscle size/mass as measured using dual energy x-ray absorptiometry (DEXA) scanning. Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- ACL Reconstruction
- What is being tested?
- Whey protein isolate and Protein + BAA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2024to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects will include patients age 16 to 40 undergoing primary ACL reconstruction for an acute ACL tear with the PI or Sub-investigators
Who cannot join
- Subjects will not be included if they meet one of the following criteria
- History of meniscectomy or meniscus repair
- Obesity (BMI>35)
- Diabetes
- Cardiovascular, renal, liver or pulmonary disease
- Active infections
Show all 23Show fewer
- Cancer (current or treated within the past 2 years) or coagulation disorder
- Rapid weight change within the past year
- Physically unable to participate in the intervention
- Are currently taking, or recently (w/in 1 month of participation) taken prescribed, or over the counter ergogenic aids or compounds known to be banned by the NCAA.
- Less than 16 years of age
- Vegan patients
- Patient over the age of 40
- Pregnancy ( As part of standard of care, all female participants will be administered a urine pregnancy test prior to surgery. A negative test result is required to participate in the study.)
- Any known or diagnosed kidney, GI, or liver disorders
- Taking any medications known to affect protein metabolism. This includes, but is not limited to any drugs involved in hormone replacement therapy to treat conditions such as:
- Hypothyroidism: example - levothyroxine
- Hypogonadism: example - exogenous testosterone, estrogen, or any other forms of androgenic or anabolic hormone compounds
- Growth hormone or growth hormone analogues
- Type I or Type II diabetes requiring insulin
- Currently taking protein supplements, amino acid supplements, or any known ergogenic aids.
- Notably, all patients would need to confirm they will be doing their rehab through Houston Methodist
- Patients diagnosed with protein intolerance or digestive issues associated with consuming protein
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist
Houston, Texas, 77030
Haley Goble, MHA, 713-441-3930, hmgoble@houstonmethodist.org
Robert A Jack, MD
About this study
Official title: The Effect of Protein Supplementation on Muscle Atrophy After ACL Reconstruction
The purpose of the study is to assess the longitudinal post-operative care effects of protein supplementation on muscle atrophy in the post-operative period following ACL reconstruction. The main outcome will be muscle size/mass as measured using dual energy x-ray absorptiometry (DEXA) scanning. The primary objective is to assess for any beneficial impact of protein supplementation, with implications of standardizing a recommended protocol for protein supplementation after ACL reconstruction.
Secondary outcomes will be to evaluate the survey data from the KOOS JR and Tampa Scale surveys, as well as functional measures recorded during physical therapy.
Read the detailed description
This study is designed to evaluate non-interventional longitudinal post-operative clinical improvement. The proposed study is a randomized non-interventional, double blind study. Subjects will include patients age 16 to 40 undergoing primary ACL reconstruction for an acute ACL tear. Demographic information including age, sex, BMI, and sport participation will be obtained from patients at the time of recruitment.
Subjects will be randomized to one of three categories: 1)placebo, 2)protein supplementation, or 3)protein supplementation with amino acids. The probability is is a 1 in 3 chance to be enrolled in each group. Participants will be provided the supplement drink immediately following surgery and will be asked to consume the supplement 2-times daily following ACL reconstruction for a total of 12 weeks post-op. In addition, participants will be asked to complete a weekly food diary in which they track their diet for 2 week days and 1 weekend day each week for all 12 weeks. This will help account for dietary proteins. Subjects will also be asked to complete the KOOS Jr and Tampa Scale surveys (attached in the application) through Houston Methodist's Redcap system at each time point (Pre-op, 4, 8 and 12 weeks postop).
Briefly, BCAAs (particularly leucine) represent primary triggers for the stimulation of protein synthesis via signaling through the mammalian target of rapamycin complex 1 pathway (mTORC1) in skeletal muscle and other tissues. Whey hydrolysate is a complete protein source that is considered to be "fast absorbing." Casein is a complete protein source that is "slow absorbing" relative to whey.9 All protein sources used in this investigation are commercially available nutritional supplements. The placebo will include a crystallite drink.
Standard of care clinic assessments such as bilateral muscle strength and stability screening will be performed in all patients at 8 and 12 weeks of rehabilitation. Time to return to sport for those subjects participating in a recreational or professional sport activities will also be recorded. Lastly, quadriceps muscle mass measured through dual energy x-ray absorptiometry (DEXA) scanning. Participants in all 3 groups will undergo DEXA scanning at once pre-operatively, 4 weeks post-op,8 weeks, post-op and 12 weeks post-op following ACL reconstruction.
The Tampa Scale and KOOS JR surveys will be administered at each study visit. The purpose of these surveys are to evaluate patient perception of surgery and their injury. As stated in the purpose, these will act as secondary outcomes to this study.
- Conditions
- ACL Reconstruction
- Being tested
- Whey protein isolate, Protein + BAA, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey protein isolateDietary supplement
25g of whey protein isolate
Protein + BAADietary supplement
- Protein drink - 25g of whey protein isolate
- Amino Acid Blend - 7g of protein (4g Leucine, 1g iso leucine, 1g valine, 1g arginine)
PlaceboDietary supplement
- isocaloric-matched (25g) maltodextrin supplement
| Study group | Role | What they receive |
|---|---|---|
| Protein Supplement Group | Experimental | Participants in this group will receive 25g of whey protein isolate twice a day for 12 weeks. Receives: Dietary Supplement: Whey protein isolate |
| Protein + Amino Acid Supplement Group | Experimental | * Protein drink - 25g of whey protein isolate
* Amino Acid Blend - 7g of protein (4g Leucine, 1g iso leucine, 1g valine, 1g arginine)
Twice a day for 12 weeks Receives: Dietary Supplement: Whey protein isolate; Dietary Supplement: Protein + BAA |
| Placebo Group | Placebo comparator | • isocaloric-matched (25g) maltodextrin supplement
Twice a day for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
Lean mass in the effected limb
Measured: Pre-operation, 4, 8 and 12 weeks post-operation
Secondary outcomes (2)
Patient Reported Outcomes
Knee injury and osteoarthritis outcome score (KOOS) JR Survey - This is a survey regarding pain and stiffness in the knee. Scales range from 1 (none) to 5 (extreme)
Measured: Pre-operation 4, 8 and 12 weeks post-operation
Patient Reported Outcomes
Tampa Scale Survey - This is a patient perception scale of injury from a scale from 1 strongly disagree to 4 strongly agree.
Measured: Pre-operation 4, 8 and 12 weeks post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start16 Feb 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL ReconstructionStudies 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
- Model description
- Subjects are randomized to 1 of 3 intervention groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick McCulloch,MD, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311058
- Sponsor's protocol ID
- PRO00032531
- Status last verified
- May 2025
- First submitted
- 16 Feb 2024
- Last updated
- 6 May 2025
- 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 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Protein Supplementation on Muscle Atrophy After ACL Reconstruction
- ClinicalTrials.gov ID
- NCT06311058
- Acronym / sponsor ID
- PRO00032531
- Conditions
- ACL Reconstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 15 Mar 2024 (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.
The purpose of the study is to assess the longitudinal post-operative care effects of protein supplementation on muscle atrophy in the post-operative period following ACL reconstruction. The main outcome will be muscle size/mass as measured using dual energy x-ray absorptiometry (DEXA) scanning. The primary objective is to assess for any beneficial impact of protein supplementation, with implications of standardizing a recommended protocol for protein supplementation after ACL reconstruction.
Secondary outcomes will be to evaluate the survey data from the KOOS JR and Tampa Scale surveys, as well as functional measures recorded during physical therapy.
Detailed description
This study is designed to evaluate non-interventional longitudinal post-operative clinical improvement. The proposed study is a randomized non-interventional, double blind study. Subjects will include patients age 16 to 40 undergoing primary ACL reconstruction for an acute ACL tear. Demographic information including age, sex, BMI, and sport participation will be obtained from patients at the time of recruitment.
Subjects will be randomized to one of three categories: 1)placebo, 2)protein supplementation, or 3)protein supplementation with amino acids. The probability is is a 1 in 3 chance to be enrolled in each group. Participants will be provided the supplement drink immediately following surgery and will be asked to consume the supplement 2-times daily following ACL reconstruction for a total of 12 weeks post-op. In addition, participants will be asked to complete a weekly food diary in which they track their diet for 2 week days and 1 weekend day each week for all 12 weeks. This will help account for dietary proteins. Subjects will also be asked to complete the KOOS Jr and Tampa Scale surveys (attached in the application) through Houston Methodist's Redcap system at each time point (Pre-op, 4, 8 and 12 weeks postop).
Briefly, BCAAs (particularly leucine) represent primary triggers for the stimulation of protein synthesis via signaling through the mammalian target of rapamycin complex 1 pathway (mTORC1) in skeletal muscle and other tissues. Whey hydrolysate is a complete protein source that is considered to be "fast absorbing." Casein is a complete protein source that is "slow absorbing" relative to whey.9 All protein sources used in this investigation are commercially available nutritional supplements. The placebo will include a crystallite drink.
Standard of care clinic assessments such as bilateral muscle strength and stability screening will be performed in all patients at 8 and 12 weeks of rehabilitation. Time to return to sport for those subjects participating in a recreational or professional sport activities will also be recorded. Lastly, quadriceps muscle mass measured through dual energy x-ray absorptiometry (DEXA) scanning. Participants in all 3 groups will undergo DEXA scanning at once pre-operatively, 4 weeks post-op,8 weeks, post-op and 12 weeks post-op following ACL reconstruction.
The Tampa Scale and KOOS JR surveys will be administered at each study visit. The purpose of these surveys are to evaluate patient perception of surgery and their injury. As stated in the purpose, these will act as secondary outcomes to this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects are randomized to 1 of 3 intervention groups
| Arm | Type | Receives |
|---|---|---|
| Protein Supplement Group | Experimental | Dietary Supplement: Whey protein isolateParticipants in this group will receive 25g of whey protein isolate twice a day for 12 weeks. |
| Protein + Amino Acid Supplement Group | Experimental | Dietary Supplement: Whey protein isolate, Dietary Supplement: Protein + BAA* Protein drink - 25g of whey protein isolate * Amino Acid Blend - 7g of protein (4g Leucine, 1g iso leucine, 1g valine, 1g arginine) Twice a day for 12 weeks |
| Placebo Group | Placebo comparator | Dietary Supplement: Placebo• isocaloric-matched (25g) maltodextrin supplement Twice a day for 12 weeks |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Subjects will include patients age 16 to 40 undergoing primary ACL reconstruction for an acute ACL tear with the PI or Sub-investigators
Key exclusion criteria (23 listed)
- Subjects will not be included if they meet one of the following criteria
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 |
|---|---|---|
| Whey protein isolate25g of whey protein isolate | Dietary supplement | Protein + Amino Acid Supplement Group, Protein Supplement Group |
| Protein + BAA* Protein drink - 25g of whey protein isolate * Amino Acid Blend - 7g of protein (4g Leucine, 1g iso leucine, 1g valine, 1g arginine) | Dietary supplement | Protein + Amino Acid Supplement Group |
| Placebo• isocaloric-matched (25g) maltodextrin supplement | Dietary supplement | Placebo Group |
Primary outcome
Muscle mass
Time frame: Pre-operation, 4, 8 and 12 weeks post-operation
Lean mass in the effected limb
2 secondary outcomes
Patient Reported Outcomes
Time frame: Pre-operation 4, 8 and 12 weeks post-operation
Patient Reported Outcomes
Time frame: Pre-operation 4, 8 and 12 weeks post-operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: No
Related trials for ACL Reconstruction
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Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
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BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
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Quadriceps Strengthening ACL Reconstruction
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RecruitingObservational study
Evaluation of the Correlation Between Bone Tunnel Projection Placement and Clinical Outcomes in Anterior Cruciate Ligament Reconstruction Surgery
Anterior Cruciate Ligament Injury, Tunneling Technique
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein isolate and Protein + BAA in people with ACL Reconstruction, run by The Methodist Hospital Research Institute 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 23 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: looking for participants now, as of the sponsor's last update on 6 May 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haley Goble, MHA (7134413930, hmgoble@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mass (time frame: Pre-operation, 4, 8 and 12 weeks post-operation). 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 6 May 2025.