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HMB Supplementation for Muscle Atrophy After Surgery (FAKS-HMB Trial)

Phase 2

Recruiting

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 6 weeks for 9-months

Awards & highlights

FAKS-HMB Trial Summary

This trial will look at the effects of a supplement on muscle size & function after knee surgery, in injured female athletes, to optimize recovery & training.

Who is the study for?

This trial is for female athletes aged 18-35 who are undergoing ACL knee surgery and will do their rehab at an affiliated clinic. They must not be taking supplements (other than basic vitamins), have no recent injuries or surgeries on the other leg, no metal implants affecting body composition measurements, not pregnant, and free from certain psychiatric conditions.Check my eligibility

What is being tested?

The study tests if a dietary supplement called CaHMB can help maintain muscle mass and function after ACL knee surgery compared to a placebo. Participants will be randomly assigned to either the supplement group or placebo group in a double-blind manner and monitored over several weeks during rehabilitation.See study design

What are the potential side effects?

Since CaHMB is a dietary supplement rather than a drug, side effects may be minimal but could include digestive discomfort or allergic reactions for those with sensitivities to ingredients in the product.

FAKS-HMB Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 6 weeks for 9-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 6 weeks for 9-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 weeks for 9-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in leg lean muscle mass

Muscle Mass

Secondary outcome measures

Change in EMG amplitude

Isometric leg strength change

Other outcome measures

ALM body composition change

Fat mass body composition change

Functional performance Asymmetry Index

+1 more

FAKS-HMB Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CaHMB+Vitamin D3-Active ExperimentalExperimental Treatment1 Intervention

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.

Group II: Calcium Lactate-Control PlaceboPlacebo Group1 Intervention

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor

463 Previous Clinical Trials

169,240 Total Patients Enrolled

National Strength and Conditioning AssociationUNKNOWN

1 Previous Clinical Trials

32 Total Patients Enrolled

Metabolic Technologies Inc.Industry Sponsor

20 Previous Clinical Trials

768 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age bracket for this clinical trial limited to those over 70 years old?

"Participants must meet the age criteria of this medical trial, which is between 18 and 35 years old."

Answered by AI

Is the CaHMB+Vitamin D3-Active Experimental regimen a medically sound choice for individuals?

"Due to the lack of evidence regarding its efficacy, CaHMB+Vitamin D3-Active Experimental has been rated a 2 on our scale for safety from 1 to 3."

Answered by AI

Are any prospective participants being welcomed into this research endeavor at the moment?

"As indicated on clinicaltrials.gov, this research is presently seeking participants. The trial was first put up for recruitment on May 29th 2023 and has since been modified as of August 31st 2023."

Answered by AI

To what extent might individuals be able to join this research?

"A total of 30 individuals with atrophy between 18 and 35 years old are potentially eligible for this clinical trial. To be admitted, they must have provided written consent to participate; moreover, female participants only should intend to complete their postoperative rehabilitation at an affiliated physical therapy clinic."

Answered by AI

How many participants are currently taking part in this clinical trial?

"Affirmative. According to the information available on clinicaltrials.gov, this trial is actively searching for participants and was initially posted on May 29th 2023. This study will be accepting 30 patients at a single site before its most recent update of August 31st 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Ashley A. Herda, Ph.D., CSCS*D 2023. "Influence of β-hydroxy β-methyl Butyrate (HMB)Supplementation on Post-operative Muscle Mass and Function in Female Athletes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05869812.