What side effects are associated with this type of intervention?

Common treatments for atrophy, such as Calcium-β-hydroxy-β-methylbutyrate (caHMB), creatine, and protein supplements, generally aim to improve muscle protein synthesis and reduce muscle protein breakdown. Known side effects of these treatments can include gastrointestinal discomfort, such as bloating, cramping, and diarrhea. In some cases, excessive protein intake can strain the kidneys, particularly in individuals with pre-existing kidney conditions. Creatine supplementation may also lead to water retention and weight gain. It is important to consult with a healthcare provider to tailor the treatment to individual health needs and monitor for any adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments aimed at addressing muscle atrophy, particularly those that enhance muscle protein synthesis and reduce muscle protein breakdown. One notable example is the use of anabolic agents like testosterone and selective androgen receptor modulators (SARMs), which have shown efficacy in increasing muscle mass and strength. Additionally, nutritional supplements such as creatine and protein supplements are commonly recommended to support muscle health. While calcium-β-hydroxy-β-methylbutyrate (caHMB) is still under investigation, its mechanism of improving muscle protein synthesis and reducing breakdown is similar to these approved treatments, highlighting its potential in managing muscle atrophy.

What other types of research exist?

Promising novel alternatives to caHMB for atrophy patients include: 1) Myostatin inhibitors, which block the activity of myostatin, a protein that inhibits muscle growth. 2) Selective Androgen Receptor Modulators (SARMs), which enhance muscle growth and bone density with fewer side effects compared to traditional anabolic steroids. 3) Branched-Chain Amino Acids (BCAAs) supplementation, which supports muscle protein synthesis and reduces muscle breakdown. 4) Nutritional interventions like high-protein diets and omega-3 fatty acids, which have been shown to support muscle health. 5) Emerging gene therapies targeting muscle growth pathways, which are currently under investigation in clinical trials.

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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

Summary

This trial will test if a muscle-building supplement called caHMB can help female athletes recover better after ACL knee surgery. The study will compare the effects of caHMB in women over 18 who have injured their ACL. caHMB works by helping muscles grow and preventing them from shrinking when not used. HMB in its free acid formulation is suggestive of having a greater potential for efficacy in both trained and untrained populations than its calcium-salt form.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in leg lean muscle mass

Muscle Mass

Secondary study objectives

Change in EMG amplitude

Isometric leg strength change

Other study objectives

ALM body composition change

Fat mass body composition change

Functional performance Asymmetry Index

+1 more

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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for atrophy, such as Calcium-β-hydroxy-β-methylbutyrate (caHMB), work by enhancing muscle protein synthesis and reducing muscle protein breakdown. caHMB, a metabolite of the amino acid leucine, stimulates the mTOR pathway, which is crucial for muscle growth, and inhibits the ubiquitin-proteasome pathway, which is responsible for muscle protein degradation. This dual action helps maintain and increase muscle mass, which is vital for atrophy patients as it improves muscle strength, functionality, and overall quality of life, especially during periods of disuse or recovery from injury.

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Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor

488 Previous Clinical Trials

172,425 Total Patients Enrolled

National Strength and Conditioning AssociationUNKNOWN

2 Previous Clinical Trials

80 Total Patients Enrolled

Metabolic Technologies Inc.Industry Sponsor

20 Previous Clinical Trials

768 Total Patients Enrolled

~0 spots leftby Oct 2024

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