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| Name | Class |
|---|---|
| National Strength and Conditioning Association | OTHER |
| Metabolic Technologies Inc. | INDUSTRY |
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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.](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CaHMB+Vitamin D3-Active Experimental | Experimental | Participants 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. |
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| Calcium Lactate-Control Placebo | Placebo Comparator | Participants 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in leg lean muscle mass | absolute leg lean mass (kg) change from baseline | every 6 weeks for 9-months |
| Change in leg lean muscle mass | absolute muscle cross-sectional area (cm^2) | every 6 weeks for 9-months |
| Muscle Mass | percent change cross-sectional area (%) | every 6 weeks for 9-months |
| Measure | Description | Time Frame |
|---|---|---|
| Isometric leg strength change | change in strength from baseline relative to contralateral limb (kg) | every 3 months for 9-months |
| Change in EMG amplitude | absolute (RMS) change from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| ALM body composition change | appendicular lean mass (kg) change from baseline | every 6 weeks for 9-months |
| Fat mass body composition change | fat mass (kg) change from baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashley Herda, PhD | Contact | 913-897-8618 | a.herda@ku.edu | |
| Sharon Bradshaw | Contact | 913-945-6289 | sbradshaw2@kumc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Health System | Recruiting | Overland Park | Kansas | 66213 | United States |
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| ID | Term |
|---|---|
| D001284 | Atrophy |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| C004961 | beta-hydroxyisovaleric acid |
| C110051 | calcium lactate |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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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)
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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.
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| CaLa | Dietary Supplement | Comparative placebo |
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| every 3 months for 9-months |
| every 6 weeks for 9-months |
| TBLM body composition change | total body lean mass (kg) change from baseline | every 6 weeks for 9-months |
| Functional performance Asymmetry Index | 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. | measured at 14 and 26 weeks |