← Back to Search

Protein Supplement

Protein + Amino Acid Supplement Group for Anterior Cruciate Ligament Reconstruction

N/A

Recruiting

Research Sponsored by The Methodist Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-operation 4, 8 and 12 weeks post-operation

Awards & highlights

Study Summary

This trial aims to study the impact of protein supplementation on muscle atrophy after ACL reconstruction surgery. The main focus is on measuring muscle size using a special x-ray scan. The goal is to see if

Who is the study for?

This trial is for individuals who have undergone ACL reconstruction surgery and are looking to prevent muscle loss during their recovery. Participants should be willing to take protein supplements or a placebo as part of the study.Check my eligibility

What is being tested?

The study is testing whether taking protein supplements (Protein + BAA, Whey protein isolate) after ACL surgery helps maintain muscle mass better than a placebo. Muscle size will be measured with DEXA scans, and participants' recovery progress will also be tracked through surveys and physical therapy results.See study design

What are the potential side effects?

While not explicitly listed, potential side effects from the protein supplementation could include digestive discomfort such as bloating or gas, allergic reactions if intolerant to ingredients in the supplement, and possible kidney strain if one has pre-existing kidney conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-operation 4, 8 and 12 weeks post-operation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-operation 4, 8 and 12 weeks post-operation

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-operation 4, 8 and 12 weeks post-operation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Muscle mass

Secondary outcome measures

Patient Reported Outcomes

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Protein Supplement GroupExperimental Treatment1 Intervention

Participants in this group will receive 25g of whey protein isolate twice a day for 12 weeks.

Group II: Protein + Amino Acid Supplement GroupExperimental Treatment2 Interventions

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

Group III: Placebo GroupPlacebo Group1 Intervention

• isocaloric-matched (25g) maltodextrin supplement Twice a day for 12 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Whey protein isolate

2022

Completed Phase 1

~180

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor

274 Previous Clinical Trials

80,433 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the study open to individuals aged 80 and above?

"Enrollment is open to individuals above 16 years old but under the age of 40."

Answered by AI

Are individuals currently being enrolled in this clinical trial?

"Indeed, the details on clinicaltrials.gov confirm that this research is actively seeking participants. Originally uploaded on February 16th, 2024 and last modified on March 12th, 2024, this trial aims to enroll a total of 102 individuals at one designated site."

Answered by AI

What is the current number of participants being recruited for this research endeavor?

"Indeed, information from clinicaltrials.gov indicates that recruitment is ongoing for this trial. The trial was first listed on February 16th, 2024 and most recently updated on March 12th, 2024. It aims to enroll a total of 102 participants at one designated site."

Answered by AI

What are the specific criteria that individuals must meet in order to be eligible for participation in this trial?

"Enrollment in this research study necessitates prior anterior cruciate ligament reconstruction surgery and an age range of 16 to 40 years old. A total of 102 individuals will be recruited for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Protein Supplementation After ACL Surgery

Patrick McCulloch,MD 2024. "Protein Supplementation After ACL Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06311058.

All > Paid Studies Houston > Paid Studies Pasadena