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NCT05869812 · ClinicalTrials.gov registry record · Phase 2
Influence of β-hydroxy β-methyl Butyrate (HMB)Supplementation on Post-operative Muscle Mass and Function in Female Athletes
A Phase 2 study of Atrophy, sponsored by University of Kansas Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05869812: Recruiting Phase 2 study of Atrophy, sponsored by University of Kansas Medical Center.
NCT05869812 is a Phase 2 study of Atrophy that is actively recruiting participants, run by University of Kansas Medical Center. The registered enrollment target is 30 participants, below the 239-participant average among 5 other Atrophy trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05869812, a Phase 2 study of Atrophy, is actively recruiting participants, sponsored by University of Kansas Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
absolute leg lean mass (kg) change from baseline
Conditions Studied
Interventions
- DRUG CaHMB (Dietary supplement, not Drug)
- DIETARY_SUPPLEMENT CaLa
Study Locations (1)
Kansas
- University of Kansas Health System - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-05-29 |
| Est. Completion | 2029-12 |
| Phase | Phase 2 |
What NCT05869812 shows while recruiting
NCT05869812 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 239-participant average among 5 other Atrophy trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Atrophy appearing as the primary indexed condition, and to 2 interventions - of which CaHMB (Dietary supplement, not Drug) is the first listed.
NCT05869812 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT05869812 about?
NCT05869812 is a clinical study titled "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 ...
What is the current status of trial NCT05869812?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2023-05-29. Estimated completion is 2029-12.
What conditions does trial NCT05869812 study?
This clinical trial studies the following conditions: Atrophy.
What interventions are being tested in trial NCT05869812?
The interventions under investigation include: CaHMB (Dietary supplement, not Drug) (DRUG), CaLa (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05869812?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05869812 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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