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AtrophyPhase 2FAKS-HMBNCT05869812

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

A Phase 2 study testing CaHMB (Dietary supplement, not Drug) and CaLa in people with Atrophy, run by University of Kansas Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Atrophy
What is being tested?
CaHMB (Dietary supplement, not Drug) and CaLa
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited States
Study dates
29 May 2023to Dec 2029
Phase
Phase 2
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 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ashley Herda, PhD contact

913-897-8618

a.herda@ku.edu

Sharon Bradshaw contact

913-945-6289

sbradshaw2@kumc.edu

United States1 site, 1 recruiting
  • University of Kansas Health System

    Overland Park, Kansas, 66213

    Ashley Herda, PhD, 913-897-8618, a.herda@ku.edu

    Lisa M Vopat, MD, 913-588-6100 ext. Herda, aaherda@gmail.com

    Recruiting

Other trials in United States

About this study

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.

Conditions
Atrophy
Being tested
CaHMB (Dietary supplement, not Drug), CaLa
Keywords
musculoskeletal
Medical subject headings
Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CaHMB (Dietary supplement, not Drug)Drug

    Also called Calcium HMB, Beta-hydroxy-beta-methylbutyrate

    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.

  • CaLaDietary supplement

    Also called Calcium Lactate

    Comparative placebo

Study groups in NCT05869812
Study groupRoleWhat they receive
CaHMB+Vitamin D3-Active ExperimentalExperimentalParticipants will consume 3 g HMB with 2000 IU Vitamin D3 per day, split into two doses daily for the duration of the study, beginning 2 weeks prior to their surgical date. The first dose will be consumed 60 minutes prior to any at- home or outpatient physical therapy session and a second will be consumed immediately following the session. If a treatment day does not include any rehabilitation session, the participant will consume one dose in the morning prior to food consumption and the second dose approximately 90 minutes later.
Receives: Drug: CaHMB (Dietary supplement, not Drug)
Calcium Lactate-Control PlaceboPlacebo comparatorParticipants will consume inactive 510 mg Ca Lactate capsules per day, split into two doses daily for the duration of the study, beginning 2 weeks prior to their surgical date. The first dose will be consumed 60 minutes prior to any at- home or outpatient physical therapy session and a second will be consumed immediately following the session. If a treatment day does not include any rehabilitation session, the participant will consume one dose in the morning prior to food consumption and the second dose approximately 90 minutes later.
Receives: Dietary Supplement: CaLa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in leg lean muscle mass

    absolute leg lean mass (kg) change from baseline

    Measured: every 6 weeks for 9-months

  2. Change in leg lean muscle mass

    absolute muscle cross-sectional area (cm^2)

    Measured: every 6 weeks for 9-months

  3. Muscle Mass

    percent change cross-sectional area (%)

    Measured: every 6 weeks for 9-months

Secondary outcomes (2)
  1. Isometric leg strength change

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

    Measured: every 3 months for 9-months

  2. Change in EMG amplitude

    absolute (RMS) change from baseline

    Measured: every 3 months for 9-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2023
  2. Study start29 May 2023
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05869812
Sponsor's protocol ID
STUDY00149057
Acronym
FAKS-HMB
Status last verified
Feb 2026
First submitted
14 Mar 2023
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CaHMB (Dietary supplement, not Drug) and CaLa in people with Atrophy, run by University of Kansas Medical Center 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 3 inclusion and 8 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 2 Mar 2026. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Ashley Herda, PhD (913-897-8618, a.herda@ku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in leg lean muscle mass (time frame: every 6 weeks for 9-months). The study lists 3 primary outcomes in all. 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 2 Mar 2026.

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