Clinical trial NCT05869812: Influence of Β-hydroxy Β-methyl Butyrate (HMB)supplementation on Post-operative Muscle Mass and Function in Female Athletes
Official title: Influence of Β-hydroxy Β-methyl Butyrate (HMB)supplementation on Post-operative Muscle Mass and Function in Female Athletes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Atrophy
Keywords: musculoskeletal
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Strength and Conditioning Association
name: Metabolic Technologies Inc.
First posted: 2023-05-22
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Participant has provided written and dated informed consent to participate in the study.
2. Participant is biological female between 18 and 35 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.

Primary outcomes:
measure: Change in leg lean muscle mass
timeFrame: every 6 weeks for 9-months
measure: Change in leg lean muscle mass
timeFrame: every 6 weeks for 9-months
measure: Muscle Mass
timeFrame: every 6 weeks for 9-months
Secondary outcomes:
measure: Isometric leg strength change
timeFrame: every 3 months for 9-months
measure: Change in EMG amplitude
timeFrame: every 3 months for 9-months
Other outcomes:
measure: ALM body composition change
timeFrame: every 6 weeks for 9-months
measure: Fat mass body composition change
timeFrame: every 6 weeks for 9-months
measure: TBLM body composition change
timeFrame: every 6 weeks for 9-months
measure: Functional performance Asymmetry Index
timeFrame: measured at 14 and 26 weeks
Locations:
city: Overland Park
country: United States
facility: University of Kansas Health System
state: Kansas
Study officials:
References: