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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05869812
Acronym
FAKS-HMB
Enrollment
30
Registered
2023-05-22
Start date
2023-05-29
Completion date
2029-12-01
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrophy

Keywords

musculoskeletal

Brief summary

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.

Interventions

DRUGCaHMB (Dietary supplement, not 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.

DIETARY_SUPPLEMENTCaLa

Comparative placebo

Sponsors

University of Kansas Medical Center
Lead SponsorOTHER
National Strength and Conditioning Association
CollaboratorOTHER
Metabolic Technologies Inc.
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

The sponsor- investigator, Dr. Ashley Herda, will provide the participants with the investigational product or placebo in identical, yet coded product containers and the product manufacturer, MTI BioTech, Inc., will retain the blind code until completion of the study.

Intervention model description

This study will be conducted in a randomized, double-blind, placebo-controlled clinical trial where practitioners and participants will be blinded to the supplementation treatment (experimental product versus placebo control)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

1. Participant has provided written and dated informed consent to participate in the study. 2. Participant is biological female between 18 and 45 years of age, inclusive. 3. Participant intends to complete postoperative rehabilitation at affiliated physical therapy clinic.

Exclusion criteria

1. Participant is currently consuming nutritional supplements or has recently (regularly) consumed nutritional supplements, other than multivitamins and minerals in \<9 weeks prior to participation. 2. 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. 3. 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. 4. Participant has history of previous injury or surgery in the operative limb. 5. 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. 6. Participant is participating in another clinical trial or has received an investigational product within thirty days prior to enrollment. 7. Participant has a known allergy or sensitivity to any ingredient in the test product/s. 8. Participant is pregnant as confirmed by a urine sample and hCG test.

Design outcomes

Primary

MeasureTime frameDescription
Change in leg lean muscle massevery 6 weeks for 9-monthsabsolute leg lean mass (kg) change from baseline
Muscle Massevery 6 weeks for 9-monthspercent change cross-sectional area (%)

Secondary

MeasureTime frameDescription
Isometric leg strength changeevery 3 months for 9-monthschange in strength from baseline relative to contralateral limb (kg)
Change in EMG amplitudeevery 3 months for 9-monthsabsolute (RMS) change from baseline

Countries

United States

Contacts

CONTACTAshley Herda, PhD
a.herda@ku.edu913-897-8618
CONTACTSharon Bradshaw
sbradshaw2@kumc.edu913-945-6289

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026