Carnitine Supplementation for Arterial Stiffness
Recruiting in Palo Alto (17 mi)
Overseen byJustin P Zachariah, MD MPH
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Baylor College of Medicine
Disqualifiers: Seizure disorder, Renal failure, Diabetes, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?Hardening of the blood vessels, called arterial stiffness, is a risk factor for future heart disease and its causes are unclear. The proposed study will 1) randomly assign adolescents at high risk of stiffening blood vessels to take a protein supplement called carnitine and study its effects on arterial stiffening and 2) study carnitine related genes for their effect on arterial stiffening. The study will definitively establish a role for carnitine action as a cause of stiffening blood vessels and signal a way to treat or prevent stiffening.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have a known metabolic disorder that requires carnitine therapy, you cannot participate in the trial.
What data supports the effectiveness of the drug for arterial stiffness?
Research suggests that L-carnitine supplementation may improve walking performance in peripheral arterial disease, and low levels of L-carnitine are linked to increased arterial stiffness in patients who have had a kidney transplant. This indicates that L-carnitine might help reduce arterial stiffness.
12345Is carnitine supplementation safe for humans?
Research on carnitine supplements, including L-carnitine and levocarnitine, has been conducted in various conditions like cardiovascular diseases and hemodialysis. These studies generally suggest that carnitine is safe for human use, although specific safety data for arterial stiffness is not detailed.
36789How is the drug L-Carnitine unique in treating arterial stiffness?
L-Carnitine is unique because it is a natural compound that helps in fatty-acid metabolism and has been shown to improve endothelial function (the inner lining of blood vessels) and reduce inflammation, which are important factors in managing arterial stiffness.
346710Eligibility Criteria
This trial is for boys and girls aged 11-21 with high triglyceride levels, but not too high cholesterol or any severe health issues like kidney failure, diabetes, heart disease, seizures, or pregnancy. They should be willing to follow the study rules.Inclusion Criteria
My fasting triglyceride levels are between 130 and 500 mg/dL.
I am between 13 and 19 years old.
I am between 11 and 21 years old.
+4 more
Exclusion Criteria
I have a heart condition from birth that needed surgery or a catheter procedure.
Nonadherence to study protocol during run-in phase defined as possessing 25% more than the expected remainder of placebo supplement pro-rated to the day of assessment
I need carnitine therapy for my metabolic disorder.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive 6 months of oral carnitine supplementation or placebo to study its effects on arterial stiffness
6 months
Regular visits for monitoring and assessment
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests if a protein supplement called carnitine can prevent hardening of blood vessels in at-risk teens. Participants are randomly chosen to receive carnitine or not and researchers will also look at their genes related to carnitine.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Carnitine supplementation (CS+)Experimental Treatment1 Intervention
Carnitine supplementation in liquid form, sugar free.
Group II: Placebo (CS-)Placebo Group1 Intervention
Placebo comparator liquid similar in appearance and taste to CS+.
CS- is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as L-Carnitine for:
- Dietary supplement for heart health and energy production
🇪🇺 Approved in European Union as Levocarnitine for:
- Treatment of carnitine deficiency, adjunctive therapy for the treatment of angina pectoris
🇨🇦 Approved in Canada as L-Carnitine for:
- Dietary supplement for heart health and energy production
🇯🇵 Approved in Japan as Levocarnitine for:
- Treatment of carnitine deficiency
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Texas Children's HospitalHouston, TX
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Who Is Running the Clinical Trial?
Baylor College of MedicineLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Effect of propionyl-L-carnitine on exercise performance in peripheral arterial disease. [2019]Supplementation with propionyl-L-carnitine (PLC) may be of use in improving the exercise capacity of people with peripheral arterial disease.
Carnitine-related alterations in patients with intermittent claudication: indication for a focused carnitine therapy. [2019]Carnitine metabolism is altered in peripheral arterial disease. L-carnitine supplementation may correct these alterations and improve walking performance.
[Possibilities of sequential levocarnitin and acetylcarnitin treatment in correcting cognitive deficiency in patients with cardiovascular diseases]. [2021]To evaluate the effectiveness of sequential therapy with levocarnitine and acetylcarnitine in patients with cardiovascular pathology (arterial hypertension and/or coronary heart disease) and moderate cognitive deficits.
Association of Low Serum l-Carnitine Levels with Peripheral Arterial Stiffness in Patients Who Undergo Kidney Transplantation. [2020]l-carnitine is an important co-factor in fatty-acid metabolism, and its deficiency is associated with insulin resistance, which is independently associated with arterial stiffness. This study evaluated the relationship between serum l-carnitine level and peripheral arterial stiffness (PAS) in kidney transplantation (KT). Fasting blood samples were collected from 65 patients who underwent KT. We measured the brachial-ankle pulse wave velocity, and 36 patients (55.4%) had PAS. Patients with PAS had a significantly higher percentage of diabetes (p = 0.001), hypertension (p = 0.033), and metabolic syndrome (p = 0.044); higher waist circumference (p = 0.010), systolic blood pressure (p = 0.002), serum triglyceride level (p = 0.040), insulin level (p = 0.002), and homeostasis model assessment of insulin resistance (p = 0.002); lower high-density lipoprotein cholesterol (p = 0.036) and serum l-carnitine levels (p < 0.001); older age (p = 0.041); and a longer KT duration (p = 0.025) than those without PAS. Statistical analysis revealed an independent association between PAS in KT and KT duration (95% confidence interval (CI): 1.003-1.054, p = 0.029) and serum l-carnitine levels (95% CI: 0.842-0.998, p = 0.044). The area under the receiver operating characteristic curve indicated that the diagnostic power of l-carnitine to predict PAS was 0.789 (95% CI: 0.670-0.881, p < 0.001). Serum-free l-carnitine level is negatively associated with PAS in patients who undergo KT.
L-propionyl-carnitine protects tissues from ischaemic injury in an 'in vivo' human ischaemia-reperfusion model. [2021]To assess the acute effects of L-propionyl-carnitine (LPC) on vaso-motion, tissue perfusion and tissue acidosis during an ischaemia-reperfusion test in patients with intermittent claudication.
L-carnitine and taurine synergistically inhibit the proliferation and osteoblastic differentiation of vascular smooth muscle cells. [2021]To investigate the synergistic action of L-carnitine (LC) and taurine (TAU) on the proliferation and osteoblastic differentiation of vascular smooth muscle cells (VSMCs).
Effect of L-carnitine and propionyl-L-carnitine on endothelial function of small mesenteric arteries from SHR. [2022]The effect of treatment with either 200 mg x kg(-1) of L-carnitine (LC) or propionyl-L-carnitine (PLC) was studied on endothelial dysfunction of small mesenteric arteries (SMA) from spontaneously hypertensive rats (SHR) and normotensive Wistar-Kyoto (WKY) rats.
Effect of exogenous l-carnitine on aortic stiffness in dyslipidemic adolescents: Design of a quadruple-blind, randomized, controlled interventional trial. [2023]Atherosclerotic cardiovascular disease (ASCVD) risk factors including vascular remodeling leading to hypertension and dyslipidemia are prevalent among children and adolescents. Conflicting observational and Mendelian randomization data suggest endogenous carnitine may affect arterial stiffness and lipid traits. Because of this, we developed a study to evaluate the causal role for carnitine in arterial stiffness at a point when the lifecourse trajectory to hypertension can be modified.
Effects of l-carnitine supplement on serum amyloid A and vascular inflammation markers in hemodialysis patients: a randomized controlled trial. [2015]We studied the effects of l-carnitine supplement on serum amyloid A (SAA), a systemic inflammation marker, and vascular inflammation markers in hemodialysis patients.
Antiinflammatory effects of L-carnitine supplementation (1000 mg/d) in coronary artery disease patients. [2022]Inflammation mediators have been recognized as risk factors for the pathogenesis of coronary artery disease (CAD). The purpose of this study was to investigate the effect of L-carnitine supplementation (LC, 1000 mg/d) on inflammation markers in patients with CAD.