HMB + Vitamin D Supplements for Frailty
(HMB Trial)
Recruiting in Palo Alto (17 mi)
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of North Carolina, Chapel Hill
Must not be taking: Antiobesity medications
Disqualifiers: Dementia, Untreated psychiatric disorders, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The investigators aim to conduct a 12-week, single-arm, pre/post-intervention of b-hydroxy-methylbutyrate in persons aged 65 to 85 years to assess feasibility and acceptability of the intervention and study procedures, secondary outcomes of physical function and changes in multi-omics patterns, and exploratory outcomes that will allow the team to describe physical function phenotype. The investigators' primary outcomes are the: feasibility of the study procedures (including safety), feasibility of the intervention delivery, and acceptability of study procedures and measures. Secondary outcomes include: Objective and subjective physical function measures that predict disability including the 30-second sit-to-stand, knee strength, isokinetic strength, grip strength, gait speed, 400-m walk test, Pittsburgh Fatiguability, PROMIS global health-10, social support, anthropometry, National Institutes of Health (NIH) Cognitive toolbox, Automated Self-Administered 24-hour Dietary Assessment (ASA-24), Community Healthy Activities Model Programs (CHAMPS), Ultrasound Imaging, Magnetic Resonance Imaging (MRI), Changes in untargeted metabolomic profile data based on qualitative or semiquantitative analysis of the most probable detectable metabolites in laboratory samples , Discover potential metabolites that explain changes in physical function using a discovery science, precision medicine approach (discovery science approach that is exploratory)
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude those taking weight loss medications. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment HMB + Vitamin D supplements for frailty?
Research shows that HMB supplements can improve muscle strength and physical performance in older adults, and when combined with Vitamin D, they may enhance muscle function and strength, especially in those with low Vitamin D levels.
12345Is it safe to take HMB and Vitamin D supplements for frailty?
Research shows that taking HMB and Vitamin D supplements is generally safe for both young and older adults, with no serious side effects reported in studies.
13678How does the HMB + Vitamin D treatment for frailty differ from other treatments?
The HMB + Vitamin D treatment is unique because it combines Beta-hydroxymethyl butyrate (HMB), which may help with muscle health, with Vitamin D, which is linked to improved physical performance and muscle function. This combination targets frailty by potentially addressing muscle mass and strength, areas not specifically targeted by other treatments.
910111213Eligibility Criteria
This trial is for English-speaking adults aged 65 to 85 who are patients at UNC Geriatrics Medicine clinic and have chronic conditions as defined by Medicare. It's not for those with dementia, life-threatening illnesses, certain psychiatric diagnoses, recent heart failure hospitalization, advanced cancer on treatment, severe liver or kidney disease, advanced COPD or high Vitamin D levels.Inclusion Criteria
A University of North Carolina at Chapel Hill (UNC) Geriatrics Medicine clinic patient
I am between 65 and 85 years old and speak English.
Chronic medical conditions based on the 21 Medicare multiple chronic conditions
Exclusion Criteria
Individuals with life-threatening or untreated psychiatric diagnosis that would interfere with study participation
My severe COPD stops me from participating fully.
Individuals unwilling/unable to provide consent
+12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive beta-hydroxymethyl butyrate (HMB) with vitamin D3 for 12 weeks to assess feasibility and acceptability of the intervention and study procedures.
12 weeks
Weekly visits (in-person or virtual)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including changes in physical function and multi-omics patterns.
4 weeks
Participant Groups
The study tests a Beta-hydroxymethyl butyrate supplement with and without Vitamin D over 12 weeks in older adults. It aims to see if the supplements are feasible and acceptable to take while looking at their effects on physical function and changes in biological markers related to health.
1Treatment groups
Experimental Treatment
Group I: Participants with WeaknessExperimental Treatment3 Interventions
Participants will take beta-hydroxymethyl butyrate (HMB) with vitamin D3 for 12 weeks. Those participants with vitamin D3 levels \> 80 ng/dL will be provided intervention capsules without vitamin D3.
Beta-hydroxymethyl butyrate supplement is already approved in United States, European Union, Canada for the following indications:
πΊπΈ Approved in United States as Beta-hydroxy-beta-methylbutyrate for:
- Dietary supplement for muscle health and recovery
πͺπΊ Approved in European Union as Beta-hydroxy-beta-methylbutyrate for:
- Dietary supplement for muscle health and recovery
π¨π¦ Approved in Canada as Beta-hydroxy-beta-methylbutyrate for:
- Dietary supplement for muscle health and recovery
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of North Carolina at Chapel HillChapel Hill, NC
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Who Is Running the Clinical Trial?
University of North Carolina, Chapel HillLead Sponsor
North Carolina Translational and Clinical Sciences InstituteCollaborator
References
Effect of Oral Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation on Physical Performance in Healthy Old Women Over 65 Years: An Open Label Randomized Controlled Trial. [2018]Although older people are particularly liable to sarcopenia, limited research is available on beta-hydroxy-beta-methylbutyrate (HMB) supplementation in this population, particularly in healthy subjects. In this parallel-group, randomized, controlled, open-label trial, we aimed to evaluate whether an oral supplement containing 1.5 g of calcium HMB for 8 weeks could improve physical performance and muscle strength parameters in a group of community-dwelling healthy older women. Eighty healthy women attending a twice-weekly mild fitness program were divided into two equal groups of 40, and 32 of the treated women and 33 control completed the study. We considered a change in the Short Physical Performance Battery (SPPB) score as the primary outcome and changes in the peak torque (PT) isometric and isokinetic strength of the lower limbs, 6-minute walking test (6MWT), handgrip strength and endurance as secondary outcomes. Body composition was assessed with dual-energy X-ray absorptiometry (DXA) and peripheral quantitative computerized tomography (pQCT). The mean difference between the two groups on pre-post change were finally calculated (delta) for each outcome. After 8 weeks, there were no significant differences between the groupsβ SPPB, handgrip strength or DXA parameters. The group treated with HMB scored significantly better than the control group for PT isokinetic flexion (delta = 1.56Β±1.56 Nm; p = 0.03) and extension (delta = 3.32Β±2.61 Nm; p = 0.03), PT isometric strength (delta = 9.74Β±3.90 Nm; p = 0.02), 6MWT (delta = 7.67Β±8.29 m; p = 0.04), handgrip endurance (delta = 21.41Β±16.28 s; p = 0.02), and muscle density assessed with pQCT. No serious adverse effects were reported in either group. In conclusion, a nutritional supplement containing 1.5 g of calcium HMB for 8 weeks in healthy elderly women had no significant effects on SPPB, but did significantly improve several muscle strength and physical performance parameters.
Association between endogenous plasma beta-hydroxy-beta-methylbutyrate levels and frailty in community-dwelling older people. [2023]Frailty is a key element in healthy ageing in which muscle performance plays a main role. Beta-hydroxy-beta-methylbutyrate (HMB) supplementation has shown favourable effects in modulating protein synthesis, improving muscle mass and function in interventional studies. Decreased age-related endogenous HMB levels have been shown in previous studies. The aim of the present study is to assess whether there is an association between endogenous plasma HMB levels and frailty.
Long-term Effects of Calcium Ξ²-Hydroxy-Ξ²-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 Ξ²-hydroxy-Ξ²-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 Β± 0.27 kg, HMB+D vs -0.33 Β± 0.28 kg, control, p
The Effect of Ξ²-hydroxy-Ξ²-methylbutyrate (HMB) on Sarcopenia and Functional Frailty in Older Persons: A Systematic Review. [2020]Beta-hydroxy-beta-methylbutyrate (HMB) has been shown to be effective and superior to other types of protein supplements to attenuate loss of muscle mass, strength and function, however, its benefits in sarcopenic and frail older people remain unclear.
Oral Nutritional Supplement with Ξ²-hydroxy-Ξ²-methylbutyrate (HMB) Improves Nutrition, Physical Performance and Ameliorates Intramuscular Adiposity in Pre-Frail Older Adults: A Randomized Controlled Trial. [2021]Supplementation of high protein oral nutrition shakes supplemented with Ξ²-hydroxy-Ξ²-methylbutyrate (HP-HMB) has been shown to improve muscle mass, muscle strength, and physical performance in older adults, but the roles of HP-HMB supplementation on the intramuscular adiposity remained unknown. This 12-week randomized controlled trial evaluated the changes of muscle mass, muscle strength, physical performance and intramuscular adiposity among community-dwelling pre-frail older persons.
International Society of Sports Nutrition Position Stand: beta-hydroxy-beta-methylbutyrate (HMB). [2021]Position Statement: The International Society of Sports Nutrition (ISSN) bases the following position stand on a critical analysis of the literature on the use of beta-hydroxy-beta-methylbutyrate (HMB) as a nutritional supplement. The ISSN has concluded the following. 1. HMB can be used to enhance recovery by attenuating exercise induced skeletal muscle damage in trained and untrained populations. 2. If consuming HMB, an athlete will benefit from consuming the supplement in close proximity to their workout. 3. HMB appears to be most effective when consumed for 2 weeks prior to an exercise bout. 4. Thirty-eight mgΒ·kgΒ·BM-1 daily of HMB has been demonstrated to enhance skeletal muscle hypertrophy, strength, and power in untrained and trained populations when the appropriate exercise prescription is utilized. 5. Currently, two forms of HMB have been used: Calcium HMB (HMB-Ca) and a free acid form of HMB (HMB-FA). HMB-FA may increase plasma absorption and retention of HMB to a greater extent than HMB-CA. However, research with HMB-FA is in its infancy, and there is not enough research to support whether one form is superior. 6. HMB has been demonstrated to increase LBM and functionality in elderly, sedentary populations. 7. HMB ingestion in conjunction with a structured exercise program may result in greater declines in fat mass (FM). 8. HMB's mechanisms of action include an inhibition and increase of proteolysis and protein synthesis, respectively. 9. Chronic consumption of HMB is safe in both young and old populations.
The relative bioavailability of the calcium salt of Ξ²-hydroxy-Ξ²-methylbutyrate is greater than that of the free fatty acid form in rats. [2023]Ξ²-Hydroxy-Ξ²-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).
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.
Hypovitaminosis D and frailty: Epiphenomenon or causal? [2018]Vitamin D is not only a key component in the maintenance of calcium homeostasis and bone health, but has also been implicated in a myriad of other non-skeletal biologic systems. The frailty syndrome is an emerging and increasingly important concept in the field of aging, with the "physical" clinical phenotype being initially presented as the operational definition. The relationship between vitamin D and frailty is postulated to be largely mediated via the development of sarcopenia, a condition characterised by a combination of the reduction of muscle mass, plus either muscle strength or performance. Several molecular pathways may account for the development of muscle wasting in sarcopenia, and there is mounting epidemiological and laboratory evidence that supports a role of vitamin D on muscle cell proliferation and function. Although observational studies on vitamin D and frailty have not definitively established an independent relationship, interventional studies of the effect of supplemental vitamin D have yielded a positive influence on the frailty status, mainly via improvements in the physical performance. Further studies that are adequately powered and well-designed are warranted in an attempt to establish a causal relationship between vitamin D and frailty. In the absence of a consensus on the definition of the frailty syndrome, an appropriate and well-validated measure instrument for this health outcome would be recommended in the realm of frailty research.
The effects of vitamin D supplementation on frailty in older adults at risk for falls. [2022]Low serum 25-hydroxyvitamin D [25(OH)D] level is associated with a greater risk of frailty, but the effects of daily vitamin D supplementation on frailty are uncertain. This secondary analysis aimed to examine the effects of vitamin D supplementation on frailty using data from the Study To Understand Fall Reduction and Vitamin D in You (STURDY).
Low 25-hydroxyvitamin D levels and the risk of frailty syndrome: a systematic review and dose-response meta-analysis. [2019]Vitamin D deficiency and frailty are common with aging. Previous studies examining vitamin D status and frailty have produced mixed results, and in particular, the shape of the association has not been well established. We examined the association between 25-hydroxyvitamin D (25OHD) serum levels and frailty by performing a systematic review and dose-response meta-analysis.
Effect of Vitamin D3 and Omega-3 Fatty Acid Supplementation on Risk of Frailty: An Ancillary Study of a Randomized Clinical Trial. [2023]Preventive strategies for frailty are needed. Whether supplements with anti-inflammatory properties, such as vitamin D3 or marine omega-3 fatty acids, are useful for frailty prevention is unknown.
Association of low vitamin D levels with the frailty syndrome in men and women. [2021]Although both vitamin D (25-hydroxyvitamin D [25(OH)D]) insufficiency and the frailty syndrome are more prevalent in women than men, sex-specific associations have not been explored. We estimated sex-specific associations of low 25(OH)D with frailty. Vitamin D insufficiency can result in hyperparathyroidism, and thus, parathyroid hormone (PTH) was explored as a potential mediator in the relationship between 25(OH)D levels and frailty.