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New treatment option for Muscle
Official title This Study Investigates β-hydroxy-β-methylbutyrate (HMB) and 2-hydroxybenzylamine (2-HOBA), When Administered Either Individually or in Combination Contributes to an Increased Quality of Health, Specifically Improving Muscular Strength and Cognitive Functioning in Adults Over the Age of 65.
ClinicalTrials.gov ID: NCT07419633
What this study is testing
- What it's testing
- In this study, participants will be assigned to receive HMB, 2-HOBA, a combination of both, or a comparison supplement for a set period of time. During the study, participants will attend scheduled visits where researchers will assess muscle strength, physical function, and overall health.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older. Healthy volunteers may be eligible.
You may be able to join if
- . 65 years of age
- English or French speaking
- Females not of childbearing potential
- Willing to maintain current lifestyle and dietary habits, including level of physical activity, allowed medication/supplements habits for the...
You likely can't join if
- Known cardiac diseases, known arterial fibrillation, hepatic diseases, immune diseases (e.g. Individuals with an acute infectious disease, autoimmune...
- Chronic kidney disease [estimated glomerular filtration rate (GFR) \< 35 mL/min].
- Neurological injury/disorder with significant persistent neurological or functional deficit (e.g., stroke with hemiparesis, spinal cord injury...
- Neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation
- History of confirmed chronic obstructive pulmonary disease with a severity grade \> 2 on the Medical Research Council Dyspnea Scale.
- Uncontrolled hypothyroidism or hyperthyroidism. Hypothyroid patients who have changed their dose of hormone replacement therapy in the 6 weeks before...
See the full eligibility criteria
- . 65 years of age
- English or French speaking
- Females not of childbearing potential
- Willing to maintain current lifestyle and dietary habits, including level of physical activity, allowed medication/supplements habits for the duration of the study
- Known cardiac diseases, known arterial fibrillation, hepatic diseases, immune diseases (e.g. Individuals with an acute infectious disease, autoimmune disease or are immune compromised), ulcers, asthma, gout, severe...
- Chronic kidney disease [estimated glomerular filtration rate (GFR) \< 35 mL/min].
- Neurological injury/disorder with significant persistent neurological or functional deficit (e.g., stroke with hemiparesis, spinal cord injury, muscular dystrophy, myopathy, myasthenia gravis, Parkinson's disease...
- Neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation
- History of confirmed chronic obstructive pulmonary disease with a severity grade \> 2 on the Medical Research Council Dyspnea Scale.
- Uncontrolled hypothyroidism or hyperthyroidism. Hypothyroid patients who have changed their dose of hormone replacement therapy in the 6 weeks before screening are not eligible.
- Underlying muscle diseases, including a history of or currently active myopathy (e.g., dermatomyositis, polymyositis, etc.) or muscular dystrophies.
- Confirmed rheumatoid arthritis, acquired immunodeficiency syndrome (AIDS), type 1 or type 2 diabetes mellitus.
- History of cancer in the last 6 months.
- Not on any medications including NHPs/living with medical conditions that would compromise the study outcome or the safety of the research participant.
- Known allergy to study medication or its components (non-medicinal ingredients).
- Allergy to aspirin/salicylate or if using other drugs containing acetylsalicylic acid or other salicylates and a history of ASA-sensitive asthma/bronchospasm The following list of medications/NHPs will be excluded (and...
- Participants on newly initiated cholesterol-lowering medication will be excluded. Those on stable regimens for ≥3 months will be included and will be monitored for potential interactions as per the HMB monograph.
- Medications associated with muscle weakness or immune effects (i.e., oral glucocorticoids).
- Medications or supplements affecting skeletal muscle metabolism or weight including: Use of MAO-I's (monoamine oxidase inhibitors), additional consumption of 2-HOBA, Vitamin D or HMB, anabolic steroids, selective...
- Excessive protein supplementation (i.e., \>2.0 g/kg/day).
- All participants must be on a stable dose of allowed supplements/medications for at least 3 months prior to enrollment. All concomitant therapies will be documented. Non-pharmacological interventions that could...
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
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 all sexes, 65 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. 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.