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NCT Number: NCT05869812

Influence of β-hydroxy β-methyl Butyrate (HMB)Supplementation on Post-operative Muscle Mass and Function in Female Athletes

The proposed project will evaluate the musculoskeletal outcomes of quadriceps and hamstring muscle size and function following orthopedic knee surgery involving anterior cruciate ligament (ACL) repair or reconstruction. Currently, the research team collaborates with a team of orthopedic specialists at the University of Kansas Health System and monitor muscle size post-knee repair and follow the standard of care (SOC) practices of the licensed physical therapists (PT). The proposed project will include a randomized clinical trial to observe the muscular outcomes following the current SOC plus supplementation of calcium-β-hydroxy-β-methylbutyrate (caHMB) or placebo. CaHMB has been shown to improve rates of muscle protein synthesis while suppressing muscle protein breakdown in healthy adults. The use of caHMB has also provided evidence of muscular protection from atrophy during prolonged bed rest. This evidence supports the utility in clinically injured athletes that are subjected to disuse atrophy from the inability to bear weight or participate in typical daily physical activity. Additionally, matched for activity-related knee injuries, female athletes are more susceptible to incurring a significant injury due to a variety of genetic, hormonal, biological, anatomical, and biomechanical predispositions. Therefore, the proposed study will recruit approximately 30 females over the age of 18 that have sustained an injury to the ACL and will plan to undergo reconstructive knee surgery involving the ACL. Subjects will be monitored and measured prior to their surgical date (T0), at 2-weeks post operative (T1), and every 6-weeks until they are cleared to return to sport (T2-TRTS). Participants will be randomly assigned 1:1 in a double-blind manner to either an experimental (EXPHMB) or placebo (CONPLA) group. Doses will be provided to the participants in coded containers and will complete their dosing and a record log of intake for the duration of their rehabilitation. Three 3-day food, exercise, and health record logs will be collected to monitor nutritional intake, activity, and menstrual patterns at T0, T3, and TRTS. Participant's assessments will include body composition analysis via bioelectrical impedance analysis for total and segmental muscle and fat mass, skeletal muscle mass, and body fat percent. We will collect ultrasound images of the quadriceps and hamstrings of the operative-involved limb (OPIL) and non-operative limb (NOPL) limbs for muscle cross-sectional area (mCSA), thickness (mT), subcutaneous fat thickness (TFAT), and corrected echo intensity (EICOR) at all time points. Strength and functional assessments will occur upon entrance to the study (T0), and after loaded exercise is indicated by the practitioner (T3-TRTS) to the tolerance of the athlete. These assessments include maximal voluntary isometric contractions (MVIC) for leg extension and leg curl, standing balance tests, single-leg and double-leg jump assessment, and drop landing deviation, all on dual force plates. Data will be analyzed using multiple three-way analyses of variance [surgical leg (OPIL vs. NOPL) x treatment (EXPHMB vs. CONPLA) x time (T0 vs. T1 vs. T2 vs. T3 vs. T4 vs. T5 vs. TRTS) for the dependent variables. Significance is established at p≤0.05 and follow-up ANOVAS, T-tests, and post-hoc analyses will be conducted when significance is present. The evidence from this study will support the practitioners and coaches' abilities to maximize recovery and training outcomes, respectively, in previously injured female athletes.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Participant is currently consuming nutritional supplements or has recently (regularly) consumed nutritional supplements, other than multivitamins and minerals in <9 weeks prior to participation.
  • Participant currently suffers from a sleep disorder and/or has a known history of (or is currently being treated for) clinical depression, eating disorder(s) or any other psychiatric condition(s) that might limit natural recovery from substantial injury.
  • Participant has a history of orthopedic injury or surgery within the last year in the non-operative limb that may prevent them from completing the study procedures.
  • Participant has history of previous injury or surgery in the operative limb.
  • Participant has implants, hardware, devices, or other non-removable metal material in the body that would limit the accuracy of body composition assessments within the measurement area.
  • Participant is participating in another clinical trial or has received an investigational product within thirty days prior to enrollment.
  • Participant has a known allergy or sensitivity to any ingredient in the test product/s.
  • Participant is pregnant as confirmed by a urine sample and hCG test.

Treatment and study plan

CaHMB (Dietary supplement, not Drug)

Drug

The investigators will focus our effort, for the purposes of this study, on determining if adding an HMB supplement will stimulate positive outcomes and recovery of the quadriceps and hamstrings muscle architecture and function in females with ACL injury requiring surgical repair, more so than a placebo control.

Other names: Calcium HMB, Beta-hydroxy-beta-methylbutyrate

CaLa

Dietary Supplement

Comparative placebo

Other names: Calcium Lactate

Primary outcomes

  1. Change in leg lean muscle mass

    Time frame: every 6 weeks for 9-months

    absolute leg lean mass (kg) change from baseline

  2. Change in leg lean muscle mass

    Time frame: every 6 weeks for 9-months

    absolute muscle cross-sectional area (cm^2)

  3. Muscle Mass

    Time frame: every 6 weeks for 9-months

    percent change cross-sectional area (%)

Secondary outcomes

  1. Isometric leg strength change

    Time frame: every 3 months for 9-months

    change in strength from baseline relative to contralateral limb (kg)

  2. Change in EMG amplitude

    Time frame: every 3 months for 9-months

    absolute (RMS) change from baseline

Other outcomes

  1. ALM body composition change

    Time frame: every 6 weeks for 9-months

    appendicular lean mass (kg) change from baseline

  2. Fat mass body composition change

    Time frame: every 6 weeks for 9-months

    fat mass (kg) change from baseline

  3. TBLM body composition change

    Time frame: every 6 weeks for 9-months

    total body lean mass (kg) change from baseline

  4. Functional performance Asymmetry Index

    Time frame: measured at 14 and 26 weeks

    symmetry difference between limbs, expressed as a percent Drop landing knee excursion (force, impulse) Vertical jump (height, force, impulse) Cross-over hop (distance) Single-leg hop (distance) Triple hop (distance) Figure-8 hop (time-sec.) Number of leg press repetitions

    All scores aggregate to a single percent score comparing operative limb to non-operative limb.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley Herda, PhD

CONTACT

[email protected]

913-897-8618

Sharon Bradshaw

CONTACT

[email protected]

913-945-6289

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Metabolic Technologies Inc.
  • National Strength and Conditioning Association

Registry information

Acronym: FAKS-HMB

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
May 22, 2023
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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