Elevated HMB ExcretionNCT02908425
Cholesterol and Statin in Healthy Adults
A study testing Statin user in people with Elevated HMB Excretion, run by Texas A&M University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Elevated HMB Excretion
- What is being tested?
- Statin user
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2016to 1 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas A&M University CTRAL
College Station, Texas, 77845-4253
About this study
Official title: Human Metabolism of HMB
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.
Read the detailed description
The use of nutritional interventions have gained much attention and are being explored for their ability to increase muscle mass and/or attenuate loss of muscle mass. Leucine, isoleucine, and valine are branched chain amino acids that have been studied extensively and have been shown to stimulate muscle anabolism. Beta-hydroxy-beta-methylbutyrate (HMB), a metabolite of leucine, has been suggested to play a significant role in preserving muscle mass in situations that favor muscle mass loss. This is thought to occur through stabilizing sarcolemma integrity, reduced proteasome activity and expression of the proteasome 20S subunit, inhibition of apoptosis, and by activation of skeletal muscle satellite cells. Furthermore, in a catabolic-induced myotube and a murine adenocarcinoma cell line, HMB (50µM) was more potent in reversing the increased protein degradation and decreased protein synthesis compared to a higher dose of leucine (1mM). Similar findings were reported in a rodent cancer model. These data suggests that HMB plays a significant role in preventing muscle wasting.
Understanding the metabolic fate of HMB is crucial to developing strategies to increase HMB concentrations in populations that are subjected to muscle wasting. The objective of this application is to determine if a cholesterol lowering statin alters HMB metabolism in healthy adults. The Researchers will test the hypotheses that with statin administration, HMB metabolism and urinary excretion is affected and that this will have an unknown effect on the production of HMB and the response to intake of HMB precursors like leucine.
- Conditions
- Elevated HMB Excretion
- Being tested
- Statin user
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Statin userOther
Subjects will be studied on 2 occasions with both being identical. One will be after 7 days or more of cholesterol lowering statin administration and the other occasion will be after at least 4 weeks of cholesterol lowering statin discontinuation. All study visits include (but are not limited to) blood draws, urine collection, and stable isotope infusions.
| Study group | Role | What they receive |
|---|---|---|
| Healthy taking statin | Other | healthy subjects currently taking cholesterol lowering statin Receives: Other: Statin user |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta Hydroxymethyl butyrate turnover
Measures the rate that Beta Hydroxymethyl butyrate is appears in blood
Measured: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 minutes
Secondary outcomes (14)
Ketoisocapric acid turnover
Measures the rate that Ketoisocapric acid is appears in blood
Measured: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Leucine turnover
Measures the rate that Leucine is appears in blood
Measured: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Isoleucine turnover
Measures the rate that Isoleucine is appears in blood
Measured: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Ketomethylvalerate turnover
Measures the rate that Ketomethylvalerate is appears in blood
Measured: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Valine turnover
Measures the rate that Valine is appears in blood
Measured: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Ketoisovalerate turnover
Measures the rate that Ketoisovalerate is appears in blood
Measured: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Beta Hydroxymethyl butyrate concentration
Blood Beta Hydroxymethyl butyrate concentration
Measured: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Ketoisocapric acid concentration
Blood Ketoisocapric acid concentration
Measured: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Leucine concentration
Blood Leucine concentration
Measured: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Isoleucine concentration
Blood Isoleucine concentration
Measured: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Ketomethylvalerate concentration
Blood Ketomethylvalerate concentration
Measured: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Valine concentration
Blood Valine concentration
Measured: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Ketoisovalerate concentration
Blood Ketoisovalerate concentration
Measured: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Beta Hydroxymethyl butyrate concentration
Urinary Beta Hydroxymethyl butyrate concentration
Measured: 0 and 240 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study start8 Jul 2016
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Elevated HMB ExcretionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marielle PKJ Engelen, PhD, Texas A&M University
- Investigators
- Marielle Engelen, PHD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908425
- Sponsor's protocol ID
- 2015-0767
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2016
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pallottini V. 3-Hydroxy-3-methylglutaryl-coenzyme A reductase modulator: toward age- and sex-personalized medicine. Expert Opin Ther Pat. 2015;25(10):1079-83. doi: 10.1517/13543776.2015.1061996. Epub 2015 Jul 1.
PubMed 26135220Hanai J, Cao P, Tanksale P, Imamura S, Koshimizu E, Zhao J, Kishi S, Yamashita M, Phillips PS, Sukhatme VP, Lecker SH. The muscle-specific ubiquitin ligase atrogin-1/MAFbx mediates statin-induced muscle toxicity. J Clin Invest. 2007 Dec;117(12):3940-51. doi: 10.1172/JCI32741.
PubMed 17992259Thompson PD, Clarkson P, Karas RH. Statin-associated myopathy. JAMA. 2003 Apr 2;289(13):1681-90. doi: 10.1001/jama.289.13.1681.
PubMed 12672737Phillips PS, Haas RH, Bannykh S, Hathaway S, Gray NL, Kimura BJ, Vladutiu GD, England JD; Scripps Mercy Clinical Research Center. Statin-associated myopathy with normal creatine kinase levels. Ann Intern Med. 2002 Oct 1;137(7):581-5. doi: 10.7326/0003-4819-137-7-200210010-00009.
PubMed 12353945Kaufmann P, Torok M, Zahno A, Waldhauser KM, Brecht K, Krahenbuhl S. Toxicity of statins on rat skeletal muscle mitochondria. Cell Mol Life Sci. 2006 Oct;63(19-20):2415-25. doi: 10.1007/s00018-006-6235-z.
PubMed 17013560Ferrando AA, Lane HW, Stuart CA, Davis-Street J, Wolfe RR; New Collective Author. Prolonged bed rest decreases skeletal muscle and whole body protein synthesis. Am J Physiol. 1996 Apr;270(4 Pt 1):E627-33. doi: 10.1152/ajpendo.1996.270.4.E627.
PubMed 8928769Creditor MC. Hazards of hospitalization of the elderly. Ann Intern Med. 1993 Feb 1;118(3):219-23. doi: 10.7326/0003-4819-118-3-199302010-00011.
PubMed 8417639Kearns AK, Bilbie CL, Clarkson PM, White CM, Sewright KA, O'Fallon KS, Gadarla M, Thompson PD. The creatine kinase response to eccentric exercise with atorvastatin 10 mg or 80 mg. Atherosclerosis. 2008 Sep;200(1):121-5. doi: 10.1016/j.atherosclerosis.2007.12.029. Epub 2008 Feb 7.
PubMed 18261731Parker BA, Augeri AL, Capizzi JA, Ballard KD, Troyanos C, Baggish AL, D'Hemecourt PA, Thompson PD. Effect of statins on creatine kinase levels before and after a marathon run. Am J Cardiol. 2012 Jan 15;109(2):282-7. doi: 10.1016/j.amjcard.2011.08.045. Epub 2011 Oct 28.
PubMed 22036108Sinzinger H, O'Grady J. Professional athletes suffering from familial hypercholesterolaemia rarely tolerate statin treatment because of muscular problems. Br J Clin Pharmacol. 2004 Apr;57(4):525-8. doi: 10.1111/j.1365-2125.2003.02044.x.
PubMed 15025753Stein TP, Schluter MD, Leskiw MJ, Boden G; New Collective Author. Attenuation of the protein wasting associated with bed rest by branched-chain amino acids. Nutrition. 1999 Sep;15(9):656-60. doi: 10.1016/s0899-9007(99)00120-3.
PubMed 10467608Stein TP, Donaldson MR, Leskiw MJ, Schluter MD, Baggett DW, Boden G; New Collective Author. Branched-chain amino acid supplementation during bed rest: effect on recovery. J Appl Physiol (1985). 2003 Apr;94(4):1345-52. doi: 10.1152/japplphysiol.00481.2002. Epub 2002 Dec 6.
PubMed 12471043Stout JR, Smith-Ryan AE, Fukuda DH, Kendall KL, Moon JR, Hoffman JR, Wilson JM, Oliver JS, Mustad VA. Effect of calcium beta-hydroxy-beta-methylbutyrate (CaHMB) with and without resistance training in men and women 65+yrs: a randomized, double-blind pilot trial. Exp Gerontol. 2013 Nov;48(11):1303-10. doi: 10.1016/j.exger.2013.08.007. Epub 2013 Aug 24.
PubMed 23981904Deutz NE, Pereira SL, Hays NP, Oliver JS, Edens NK, Evans CM, Wolfe RR. Effect of beta-hydroxy-beta-methylbutyrate (HMB) on lean body mass during 10 days of bed rest in older adults. Clin Nutr. 2013 Oct;32(5):704-12. doi: 10.1016/j.clnu.2013.02.011. Epub 2013 Mar 4.
PubMed 23514626May PE, Barber A, D'Olimpio JT, Hourihane A, Abumrad NN. Reversal of cancer-related wasting using oral supplementation with a combination of beta-hydroxy-beta-methylbutyrate, arginine, and glutamine. Am J Surg. 2002 Apr;183(4):471-9. doi: 10.1016/s0002-9610(02)00823-1.
PubMed 11975938
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Metabolism of HMB
- ClinicalTrials.gov ID
- NCT02908425
- Acronym / sponsor ID
- 2015-0767
- Conditions
- Elevated HMB Excretion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 8 Jul 2016 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The use of nutritional interventions have gained much attention and are being explored for their ability to increase muscle mass and/or attenuate loss of muscle mass. Leucine, isoleucine, and valine are branched chain amino acids that have been studied extensively and have been shown to stimulate muscle anabolism. Beta-hydroxy-beta-methylbutyrate (HMB), a metabolite of leucine, has been suggested to play a significant role in preserving muscle mass in situations that favor muscle mass loss. This is thought to occur through stabilizing sarcolemma integrity, reduced proteasome activity and expression of the proteasome 20S subunit, inhibition of apoptosis, and by activation of skeletal muscle satellite cells. Furthermore, in a catabolic-induced myotube and a murine adenocarcinoma cell line, HMB (50µM) was more potent in reversing the increased protein degradation and decreased protein synthesis compared to a higher dose of leucine (1mM). Similar findings were reported in a rodent cancer model. These data suggests that HMB plays a significant role in preventing muscle wasting.
Understanding the metabolic fate of HMB is crucial to developing strategies to increase HMB concentrations in populations that are subjected to muscle wasting. The objective of this application is to determine if a cholesterol lowering statin alters HMB metabolism in healthy adults. The Researchers will test the hypotheses that with statin administration, HMB metabolism and urinary excretion is affected and that this will have an unknown effect on the production of HMB and the response to intake of HMB precursors like leucine.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy taking statin | Other | Other: Statin userhealthy subjects currently taking cholesterol lowering statin |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Statin userSubjects will be studied on 2 occasions with both being identical. One will be after 7 days or more of cholesterol lowering statin administration and the other occasion will be after at least 4 weeks of cholesterol lowering statin discontinuation. All study visits include (but are not limited to) blood draws, urine collection, and stable isotope infusions. | Other | Healthy taking statin |
Primary outcome
Beta Hydroxymethyl butyrate turnover
Time frame: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 minutes
Measures the rate that Beta Hydroxymethyl butyrate is appears in blood
14 secondary outcomes
Ketoisocapric acid turnover
Time frame: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Leucine turnover
Time frame: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Isoleucine turnover
Time frame: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Ketomethylvalerate turnover
Time frame: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Valine turnover
Time frame: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Ketoisovalerate turnover
Time frame: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Beta Hydroxymethyl butyrate concentration
Time frame: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Ketoisocapric acid concentration
Time frame: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Leucine concentration
Time frame: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Isoleucine concentration
Time frame: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Ketomethylvalerate concentration
Time frame: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Valine concentration
Time frame: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Ketoisovalerate concentration
Time frame: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 min
Beta Hydroxymethyl butyrate concentration
Time frame: 0 and 240 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Background: PubMed 26135220Pallottini V. 3-Hydroxy-3-methylglutaryl-coenzyme A reductase modulator: toward age- and sex-personalized medicine. Expert Opin Ther Pat. 2015;25(10):1079-83. doi: 10.1517/13543776.2015.1061996. Epub 2015 Jul 1.
- Background: PubMed 17992259Hanai J, Cao P, Tanksale P, Imamura S, Koshimizu E, Zhao J, Kishi S, Yamashita M, Phillips PS, Sukhatme VP, Lecker SH. The muscle-specific ubiquitin ligase atrogin-1/MAFbx mediates statin-induced muscle toxicity. J Clin Invest. 2007 Dec;117(12):3940-51. doi: 10.1172/JCI32741.
- Background: PubMed 12672737Thompson PD, Clarkson P, Karas RH. Statin-associated myopathy. JAMA. 2003 Apr 2;289(13):1681-90. doi: 10.1001/jama.289.13.1681.
- Background: PubMed 12353945Phillips PS, Haas RH, Bannykh S, Hathaway S, Gray NL, Kimura BJ, Vladutiu GD, England JD; Scripps Mercy Clinical Research Center. Statin-associated myopathy with normal creatine kinase levels. Ann Intern Med. 2002 Oct 1;137(7):581-5. doi: 10.7326/0003-4819-137-7-200210010-00009.
- Background: PubMed 17013560Kaufmann P, Torok M, Zahno A, Waldhauser KM, Brecht K, Krahenbuhl S. Toxicity of statins on rat skeletal muscle mitochondria. Cell Mol Life Sci. 2006 Oct;63(19-20):2415-25. doi: 10.1007/s00018-006-6235-z.
- Background: PubMed 8928769Ferrando AA, Lane HW, Stuart CA, Davis-Street J, Wolfe RR; New Collective Author. Prolonged bed rest decreases skeletal muscle and whole body protein synthesis. Am J Physiol. 1996 Apr;270(4 Pt 1):E627-33. doi: 10.1152/ajpendo.1996.270.4.E627.
- Background: PubMed 8417639Creditor MC. Hazards of hospitalization of the elderly. Ann Intern Med. 1993 Feb 1;118(3):219-23. doi: 10.7326/0003-4819-118-3-199302010-00011.
- Background: PubMed 18261731Kearns AK, Bilbie CL, Clarkson PM, White CM, Sewright KA, O'Fallon KS, Gadarla M, Thompson PD. The creatine kinase response to eccentric exercise with atorvastatin 10 mg or 80 mg. Atherosclerosis. 2008 Sep;200(1):121-5. doi: 10.1016/j.atherosclerosis.2007.12.029. Epub 2008 Feb 7.
- Background: PubMed 22036108Parker BA, Augeri AL, Capizzi JA, Ballard KD, Troyanos C, Baggish AL, D'Hemecourt PA, Thompson PD. Effect of statins on creatine kinase levels before and after a marathon run. Am J Cardiol. 2012 Jan 15;109(2):282-7. doi: 10.1016/j.amjcard.2011.08.045. Epub 2011 Oct 28.
- Background: PubMed 15025753Sinzinger H, O'Grady J. Professional athletes suffering from familial hypercholesterolaemia rarely tolerate statin treatment because of muscular problems. Br J Clin Pharmacol. 2004 Apr;57(4):525-8. doi: 10.1111/j.1365-2125.2003.02044.x.
- Background: PubMed 10467608Stein TP, Schluter MD, Leskiw MJ, Boden G; New Collective Author. Attenuation of the protein wasting associated with bed rest by branched-chain amino acids. Nutrition. 1999 Sep;15(9):656-60. doi: 10.1016/s0899-9007(99)00120-3.
- Background: PubMed 12471043Stein TP, Donaldson MR, Leskiw MJ, Schluter MD, Baggett DW, Boden G; New Collective Author. Branched-chain amino acid supplementation during bed rest: effect on recovery. J Appl Physiol (1985). 2003 Apr;94(4):1345-52. doi: 10.1152/japplphysiol.00481.2002. Epub 2002 Dec 6.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marielle Engelen, PHD principal investigator
Texas A&M University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Statin user in people with Elevated HMB Excretion, run by Texas A&M University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beta Hydroxymethyl butyrate turnover (time frame: 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02908425, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.