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New treatment option for Atrophy
Official title Influence of β-hydroxy β-methyl Butyrate (HMB)Supplementation on Post-operative Muscle Mass and Function in Female Athletes
ClinicalTrials.gov ID: NCT05869812
What this study is testing
What is CaHMB (Dietary supplement, not Drug)?
CaHMB (Dietary supplement, not Drug) is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for atrophy.
Also referred to as Calcium HMB, Beta-hydroxy-beta-methylbutyrate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- 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.
You likely can't join if
- Participant is currently consuming nutritional supplements or has recently (regularly) consumed nutritional supplements, other than multivitamins and...
- Participant currently suffers from a sleep disorder and/or has a known history of (or is currently being treated for) clinical depression, eating...
- 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...
- 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...
- Participant is participating in another clinical trial or has received an investigational product within thirty days prior to enrollment.
See the full eligibility criteria
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Overland Park, Kansas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Overland Park, Kansas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.