Actively Recruiting
Influence of b2-hydroxy b2-methyl Butyrate (HMB) Supplementation on Post-operative Muscle Mass and Function in Female Athletes
Led by University of Kansas Medical Center · Updated on 2026-03-02
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Kansas Medical Center
Lead Sponsor
N
National Strength and Conditioning Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of a dietary supplement called calcium-b2-hydroxy-b2-methylbutyrate (CaHMB) on muscle size and function after anterior cruciate ligament (ACL) repair or reconstruction surgery in female athletes. This Phase 2 randomized clinical trial focuses on females aged 18 to 45 who have sustained ACL injuries and are planning to undergo knee surgery. The study aims to understand how CaHMB supplementation combined with standard physical therapy affects recovery compared to a placebo, with attention to muscle preservation and function during rehabilitation. Participants are randomly assigned to one of two groups: one receives CaHMB with Vitamin D3, and the other receives a calcium lactate placebo. Both supplements are taken twice daily, starting two weeks before surgery and continuing through rehabilitation. Dosing is coordinated around physical therapy sessions or at set times on non-treatment days. The study includes various assessments at multiple time points: before surgery, two weeks after, and every six weeks until clearance to return to sport. Throughout the study, participants undergo body composition analysis, ultrasound imaging of thigh muscles, and strength and functional tests including maximal voluntary contractions, balance, jumping, and landing assessments. Nutritional intake, activity, and menstrual patterns are monitored with logs at specified intervals. The main outcome is the change in leg lean muscle mass over nine months. Secondary outcomes include changes in leg strength and muscle activation. Data will help improve recovery strategies for injured female athletes, with monitoring until return to sport and beyond.
CONDITIONS
Brief Title
Influence of β-hydroxy β-methyl Butyrate (HMB)Supplementation on Post-operative Muscle Mass and Function in Female Athletes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has provided written and dated informed consent to participate in the study.
- Participant is biological female between 18 and 45 years of age, inclusive.
- Participant intends to complete postoperative rehabilitation at affiliated physical therapy clinic.
You will not qualify if you...
- Participant is currently consuming nutritional supplements or has regularly consumed supplements other than multivitamins and minerals within 9 weeks prior to participation.
- Participant has a sleep disorder or a history of clinical depression, eating disorders, or other psychiatric conditions that might limit recovery.
- Participant has had orthopedic injury or surgery within the last year in the non-operative limb.
- Participant has a history of previous injury or surgery in the operative limb.
- Participant has implants, hardware, devices, or non-removable metal in the body that would affect body composition assessments.
- Participant is participating in another clinical trial or has received an investigational product within 30 days prior to enrollment.
- Participant has a known allergy or sensitivity to any ingredient in the test products.
- Participant is pregnant as confirmed by urine and hCG tests.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants begin taking the assigned supplement daily starting 2 weeks prior to their surgery.
Daily supplement intake
Duration - Up to hospital discharge
Participants undergo surgical repair of ACL injury followed by immediate post-operative care.
1 surgical visit and immediate post-operative observation
Duration - Approximately 9 months
Participants continue daily supplementation and undergo outpatient physical therapy for rehabilitation.
Daily supplement intake and physical therapy sessions; muscle mass assessments every 6 weeks; strength and EMG assessments every 3 months
Duration - Up to study completion
Participants are monitored for changes in muscle mass and function after treatment ends.
Periodic assessments as scheduled
Trial Site Locations
Total: 1 location
1
University of Kansas Health System
Overland Park, Kansas, United States, 66213
Actively Recruiting
Research Team
A
Ashley Herda, PhD
S
Sharon Bradshaw
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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