Small study aims to unravel Statins' muscle side effects
NCT ID NCT02908425
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how statins, common cholesterol-lowering drugs, affect the body's handling of a substance called HMB, which is linked to muscle health. Researchers will study 13 older adults (ages 65-80) who take statins, measuring HMB levels in blood and urine. The goal is to understand why statins can cause muscle loss and find ways to prevent it.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Beta Hydroxymethyl butyrate (HMB)
- What this could lead to
- If successful, this research could point toward new ways to prevent muscle loss in older adults taking statins.
- What could go wrong
- This is a small, early-stage study with only 13 participants, focused on understanding metabolism rather than testing a treatment. Results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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13 people
The number who actually took part.
- Started
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Jul 2016
- Finished
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Mar 2017
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: * Male and Female, Age ≥ 65 y to 80 y * BMI \>20 but less than or equal to 35 * Currently taking a cholesterol lowering statin * Stable body-weight (± 5%) for the past 3 months * Subject is judged to be in satisfactory health based on medical history, physical examination, and laboratory screening evaluations. * Ability to walk, sit down and stand up independently * Ability to lie in supine or elevated position for up to 8 hours * Willingness and ability to comply with the protocol Exclusion criteria: * Metabolic diseases including diabetes, hepatic or renal disorder * Subject has malignant disease or autoimmune disease * Subject has impaired liver function * Subject has had a significant cardiovascular event (e.g. myocardial infarction, stroke) ≤ 6 months prior to screening visit; or stated history of congestive heart failure * Subject has current significantly impaired liver function in the opinion of the study PI (mild asymptomatic fatty liver is acceptable), or hepatic enzyme tests are ≥2.5 times normal limit * Subject has a chronic, contagious, infectious disease, such as active tuberculosis, hepatitis B or C, or HIV * Subject has chronic disease such as COPD * Subject is expected to have surgery within one-month of screening * Subject is currently participating or has participated in a study with an investigational compound or device within 30 days of signing the informed consent. * Presence of acute illness or metabolically unstable chronic illness (unrelated to the primary disease) * Unwilling to stop taking nutritional protein supplements within 5 days of first study day * Any other condition according to the PI or nurse that would interfere with the study or safety of the subject or influence the results * Presence of fever within the last 3 days * Untreated metabolic diseases including hepatic or renal disorder unrelated to the primary disease * Active dependence of alcohol or drugs * Medication: Use of substances known to influence amino acid metabolism: antibiotics within 3 weeks prior to the study visit, current use of corticosteroids, growth hormone, testosterone, estrogen, immunosuppressant, blood thinners, or insulin. * Subject cannot refrain from taking dietary supplements/substances that could modulate metabolism or weight in the opinion of the principal investigator or physician, starting four weeks prior to enrollment and over the entire course of the study such as b-hydroxy-b-methyl butyrate (HMB) or products containing HMB * Adherence to a weight loss diet. * Currently taking any drugs that impact liver function * Subject having elevated blood CK/CPK levels (3-10X above normal range)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Texas A&M University CTRAL
College Station, Texas, 77845-4253, United States