HMB Supplementation for Muscle Atrophy After Surgery (FAKS-HMB Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Kansas Medical Center
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Do I need to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it does exclude participants who are currently consuming nutritional supplements other than multivitamins and minerals. It's best to discuss your specific medications with the trial coordinators.
What data supports the effectiveness of the treatment CaHMB for muscle atrophy after surgery?
Research shows that HMB, a component of CaHMB, can help improve muscle mass and strength in various groups, including athletes, older adults, and patients with cancer. Additionally, studies indicate that HMB can reduce muscle wasting and promote muscle recovery in aged animals and improve muscle function in older adults, suggesting potential benefits for muscle atrophy after surgery.
12345Is HMB supplementation safe for humans?
Research shows that HMB, including its calcium salt form CaHMB, is generally safe for humans. Studies in animals and humans have not found any harmful effects, and it has been well-tolerated in various doses.
12678How does HMB supplementation differ from other treatments for muscle atrophy after surgery?
HMB supplementation is unique because it enhances muscle protein synthesis and reduces muscle breakdown, which helps prevent muscle loss and promotes recovery. Unlike other treatments, HMB is available in two forms, calcium salt and free acid, with the calcium salt form having greater bioavailability, meaning the body can use it more effectively.
39101112Eligibility Criteria
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.Participant Groups
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.
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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of Kansas Health SystemOverland Park, KS
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Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
National Strength and Conditioning AssociationCollaborator
Metabolic Technologies Inc.Industry Sponsor
References
Impact of ß-hydroxy-ß-methylbutyrate (HMB) in critically ill patients on the endocrine axis - A post-hoc cohort study of the HMB-ICU trial. [2023]β-hydroxy-β-methylbutyrate (HMB) might improve muscle function and maintain its mass in critically ill patients. We aimed to investigate whether the administration of HMB influenced the plasma levels of growth hormone (GH)/insulin-like growth factor-1 (IGF-1), C-peptide, and 25-OH vitamin-D.
β-hydroxy-β-methylbutyrate-enriched nutritional supplements for obese adults during weight loss: study protocol of a randomised, double-blind, placebo-controlled clinical trial. [2022]Obesity is a public health challenge worldwide. To maintain a healthy weight, dieting and lifestyle changes are the first-line interventions; however, these interventions are of poor compliance and may cause body composition changes, mainly skeletal muscle wasting (sarcopenia). Dietary supplements for improving body composition while inducing weight loss are therefore needed. β-hydroxy-β-methylbutyrate (HMB) has been proven to be effective for improving muscle mass and muscle strength in athletes, older adults and patients with cancer. We aim to evaluate the effectiveness and safety of HMB-enriched nutritional supplements for improving muscle mass and muscle function in obese adults during calorie restriction.
β-Hydroxy-β-methylbutyrate reduces myonuclear apoptosis during recovery from hind limb suspension-induced muscle fiber atrophy in aged rats. [2023]β-Hydroxy-β-methylbutyrate (HMB) is a leucine metabolite shown to reduce protein catabolism in disease states and promote skeletal muscle hypertrophy in response to loading exercise. In this study, we evaluated the efficacy of HMB to reduce muscle wasting and promote muscle recovery following disuse in aged animals. Fisher 344×Brown Norway rats, 34 mo of age, were randomly assigned to receive either Ca-HMB (340 mg/kg body wt) or the water vehicle by gavage (n = 32/group). The animals received either 14 days of hindlimb suspension (HS, n = 8/diet group) or 14 days of unloading followed by 14 days of reloading (R; n = 8/diet group). Nonsuspended control animals were compared with suspended animals after 14 days of HS (n = 8) or after R (n = 8). HMB treatment prevented the decline in maximal in vivo isometric force output after 2 wk of recovery from hindlimb unloading. The HMB-treated animals had significantly greater plantaris and soleus fiber cross-sectional area compared with the vehicle-treated animals. HMB decreased the amount of TUNEL-positive nuclei in reloaded plantaris muscles (5.1% vs. 1.6%, P
β-Hydroxy-β-methylbutyrate (HMB) supplementation and functional outcomes in multi-trauma patients: a study protocol for a pilot randomised clinical trial (BOOST trial). [2022]There are no therapies proven to diminish the muscle wasting that occurs in patients after major trauma who are admitted to the intensive care unit (ICU). β-Hydroxy-β-methylbutyrate (HMB) is a nutrition intervention that may attenuate muscle loss and, thereby, improve recovery. The primary aim of this study is to determine the feasibility of a blinded randomised clinical trial of HMB supplementation to patients after major trauma who are admitted to the ICU. Secondary aims are to establish estimates for the impact of HMB when compared to placebo on muscle mass and nutrition-related patient outcomes.
Long-term Effects of Calcium β-Hydroxy-β-Methylbutyrate and Vitamin D3 Supplementation on Muscular Function in Older Adults With and Without Resistance Training: A Randomized, Double-blind, Controlled Study. [2021]The primary aim of this study was to determine whether supplementation with calcium β-hydroxy-β-methylbutyrate (HMB) and vitamin D3 (D) would enhance muscle function and strength in older adults. Older adults over 60 years of age with insufficient circulating 25-hydroxy-vitamin D (25OH-D) levels were enrolled in a double-blinded controlled 12-month study. Study participants were randomly assigned to treatments consisting of: (a) Control + no exercise, (b) HMB+D + no exercise, (c) Control + exercise, and (d) HMB+D + exercise. The study evaluated 117 participants via multiple measurements over the 12 months that included body composition, strength, functionality, and questionnaires. HMB+D had a significant benefit on lean body mass within the nonexercise group at 6 months (0.44 ± 0.27 kg, HMB+D vs -0.33 ± 0.28 kg, control, p
Genotoxicity assessment of calcium β-hydroxy-β-methylbutyrate. [2019]β-Hydroxy-β-methylbutyrate (HMB) is a leucine metabolite available in calcium salt (CaHMB) and free acid forms as a sports nutrition ergogenic aid. HMB has also been used to support muscle health in the elderly and other populations needing to maintain muscle mass. Several human studies have reported safety data for CaHMB, and rodent sub-chronic toxicity studies have been conducted; however, there are no published genotoxicity studies for HMB. Therefore, three studies (a bacterial reverse mutation test, an in vitro mammalian chromosomal aberration test, and an in vivo mammalian cell micronucleus test) were performed. In the Ames test, no changes in revertant colonies or background were noted with CaHMB concentrations up to 5000 μg per plate, either with or without metabolic activation in five bacterial strains. In the chromosomal aberration test, the number of aberrations associated with up to 2.5 mM CaHMB (long-term) or 10.0 mM (short-term) were similar to those observed for negative controls (<5%), and no polyploidy was observed. Lastly, in the mammalian micronucleus test, no changes in immature erythrocyte or micronuclei frequencies were observed in animals treated with up to 2000 mg·kg-1 body weight CaHMB. In conclusion, CaHMB was determined to have no genotoxic effects.
The effect of β-hydroxy β-methylbutyrate (HMB) with nutritional counselling on anthropometric muscle mass markers, strength, functionality, and quality of life in patients on the waiting list for liver transplantation: A double-blind study. [2023]Patients on the waiting list for liver transplantation (LTx) usually lose muscle mass. Supplementation with β-hydroxy β-methylbutyrate (HMB) may have a promising effect on this clinical condition. This study aimed to evaluate the effects of HMB on muscle mass, strength, functionality, and quality of life in patients on the LTx waiting list.
Dietary toxicity of calcium beta-hydroxy-beta-methyl butyrate (CaHMB). [2012]HMB, 3-hydroxy-3-methyl butyrate, is of interest as a dietary supplement and a possible component of functional and medical foods. The purpose of this study was to evaluate the toxicity of the calcium salt of HMB, calcium 3-hydroxy-3-methyl butyrate (CaHMB, monohydrate, food grade), when administered daily in the diet of rats for at least 90 days. Male and female Crl:CD (SD)IGS BR animals were assigned to four groups. Each group received diets containing the carrier or 1%, 2%, or 5% of CaHMB mixed with diet. Assessment of toxicity was based on mortality, clinical observations, body weights, food consumption, and clinical and anatomic pathology evaluations. Administration of CaHMB in basal diet for 91 days was tolerated well. There were no unscheduled sacrifices or deaths. There were no CaHMB-related adverse effects on clinical observations, body weights, food consumption, clinical chemistry, hematology, absolute or relative organ weights, or macroscopic or microscopic observations. A statistically significant increase in inorganic phosphorous was observed in male animals in the 5% feeding group; however, this effect was not considered adverse. Based on the results of this study, the no-observed-adverse-effect level (NOAEL) was considered to be 5% of CaHMB mixed with diet (3.49 g/kg BW for males and 4.16 g/kg BW for females).
The relative bioavailability of the calcium salt of β-hydroxy-β-methylbutyrate is greater than that of the free fatty acid form in rats. [2023]β-Hydroxy-β-methylbutyrate (HMB) supplementation has been demonstrated to enhance muscle protein synthesis and attenuate loss of muscle mass by multiple pathways. The beneficial effects of HMB have been studied by using either the calcium salt, monohydrate, of HMB (CaHMB) or the free acid form (FAHMB).
Impact of the calcium form of β-hydroxy-β-methylbutyrate upon human skeletal muscle protein metabolism. [2023]β-hydroxy-β-methylbutyrate (HMB) is purported as a key nutritional supplement for the preservation of muscle mass in health, disease and as an ergogenic aid in exercise. Of the two available forms of HMB (calcium (Ca-HMB) salt or free acid (FA-HMB)) - differences in plasma bioavailability have been reported. We previously reported that ∼3 g oral FA-HMB increased muscle protein synthesis (MPS) and reduced muscle protein breakdown (MPB). The objective of the present study was to quantify muscle protein metabolism responses to oral Ca-HMB.
Beta-hydroxy-beta-methylbutyrate supplementation and functional outcomes in multitrauma patients: A pilot randomized controlled trial. [2023]Beta-hydroxy-beta-methylbutyrate (HMB) is a nutrition supplement that may attenuate muscle wasting from critical illness. This trial aimed to determine feasibility of administering a blinded nutrition supplement in the intensive care unit (ICU) and continuing it after ICU discharge.
β-Hydroxy-β-methylbutyrate and its impact on skeletal muscle mass and physical function in clinical practice: a systematic review and meta-analysis. [2023]Loss of skeletal muscle mass and muscle weakness are common in a variety of clinical conditions with both wasting and weakness associated with an impairment of physical function. β-Hydroxy-β-methylbutyrate (HMB) is a nutrition supplement that has been shown to favorably influence muscle protein turnover and thus potentially plays a role in ameliorating skeletal muscle wasting and weakness.