Cholesterol and Statin in Healthy Adults

Completed · Not applicable

Conditions studied: Elevated HMB Excretion

In brief

Statins are a class of drugs that are the most commonly prescribed medications in developing countries. Statins act on the enzyme HMG-CoA reductase to inhibit its conversion to mevalonate, a precursor for cholesterol synthesis. Subsequently statins are prescribed to patients with relatively high blood cholesterol levels. However, taking statins does not come without side effects. Most notably, the effects of statins on muscle wasting have been studied extensively. This includes up-regulation of the ubiquitin proteasome system, muscle cell damage and rhabdomyolysis, elevated creatine kinase, and mitochondrial dysfunction. Due to the negative side effects of statin therapy, additional therapies are warranted to help offset the effects on muscle wasting. Loss of muscle mass is a significant concern as it is associated with a reduction in muscle strength and power (Ferrando et al., 1996; Creditor, 1993). This condition is observed in aging, disease states, and long periods of unloading such as hospital admission and can lead to disability, increased falls, loss of independence, and mortality. Subsequently, there is a critical need to develop interventions to counteract this loss of muscle mass and strength. Exercise is one such intervention, however, in some cases may not be a feasible option. For instance, exercise has been demonstrated to exacerbate the muscle side of effects of statins. Subjects complain of increased muscle soreness and have elevated creatine kinase levels and they also do not want to take statins anymore (Kearns et al., 2008; Parker et al., 2012; Sinzinger et al., 2004). Because of this limitation, there is a critical need to develop other interventions that can prevent the loss of muscle mass during statin use.

Key facts

Study ID: NCT02908425
Run by: Texas A&M University
People needed: 13
Starts: 2016-07-08
Expected to finish: 2017-03-01
Last updated by the study team: 2025-09-30

Who can join

Age: 65 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)

Where it is running

Texas A&M University CTRAL — College Station, Texas, United States

Full record on ClinicalTrials.gov

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