90 Participants Needed

Carnitine Supplementation for Arterial Stiffness

DG
SP
Overseen BySandra Pena, CCRP
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Baylor College of Medicine
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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.12345

Is 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.16789

How 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.126710

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.

Research Team

JP

Justin P Zachariah, MD MPH

Principal Investigator

Study Principal Investigator

Eligibility 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.
See 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.
See 5 more

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

Treatment Details

Interventions

  • CS-
  • CS+
Trial Overview 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.
Participant Groups
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:

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Approved in United States as L-Carnitine for:
  • Dietary supplement for heart health and energy production
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Approved in European Union as Levocarnitine for:
  • Treatment of carnitine deficiency, adjunctive therapy for the treatment of angina pectoris
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Approved in Canada as L-Carnitine for:
  • Dietary supplement for heart health and energy production
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Approved in Japan as Levocarnitine for:
  • Treatment of carnitine deficiency

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials
1,044
Recruited
6,031,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Findings from Research

In a study of 120 patients aged 54-67 with cardiovascular issues and moderate cognitive deficits, the addition of levocarnitine and acetylcarnitine to standard treatment significantly reduced cognitive deficits over a follow-up period of 70 days.
The treatment was well-tolerated and safe, suggesting that these compounds may help improve cognitive function by correcting endothelial dysfunction in patients with cardiovascular conditions.
[Possibilities of sequential levocarnitin and acetylcarnitin treatment in correcting cognitive deficiency in patients with cardiovascular diseases].Statsenko, ME., Turkina, SV.[2021]
In a study of 65 kidney transplant patients, lower serum levels of l-carnitine were significantly associated with higher rates of peripheral arterial stiffness (PAS), indicating that l-carnitine may play a protective role in vascular health post-transplant.
The research found that l-carnitine levels can independently predict PAS, with a diagnostic power of 0.789, suggesting that monitoring l-carnitine could be important for managing cardiovascular risks in kidney transplant patients.
Association of Low Serum l-Carnitine Levels with Peripheral Arterial Stiffness in Patients Who Undergo Kidney Transplantation.Lai, YH., Lee, MC., Ho, GJ., et al.[2020]
In a 12-week study involving seven patients with peripheral arterial disease, supplementation with propionyl-L-carnitine (PLC) at 2 g per day showed a modest improvement in walking performance for some individuals, despite no significant increase in the overall group.
Muscle strength significantly increased from 695 N to 812 N after 4 weeks of PLC supplementation, indicating that PLC may enhance muscle strength in patients with peripheral arterial disease.
Effect of propionyl-L-carnitine on exercise performance in peripheral arterial disease.Barker, GA., Green, S., Askew, CD., et al.[2019]

References

1.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Possibilities of sequential levocarnitin and acetylcarnitin treatment in correcting cognitive deficiency in patients with cardiovascular diseases]. [2021]
Association of Low Serum l-Carnitine Levels with Peripheral Arterial Stiffness in Patients Who Undergo Kidney Transplantation. [2020]
Effect of propionyl-L-carnitine on exercise performance in peripheral arterial disease. [2019]
Carnitine-related alterations in patients with intermittent claudication: indication for a focused carnitine therapy. [2019]
L-propionyl-carnitine protects tissues from ischaemic injury in an 'in vivo' human ischaemia-reperfusion model. [2021]
L-carnitine and taurine synergistically inhibit the proliferation and osteoblastic differentiation of vascular smooth muscle cells. [2021]
Effect of L-carnitine and propionyl-L-carnitine on endothelial function of small mesenteric arteries from SHR. [2022]
Effect of exogenous l-carnitine on aortic stiffness in dyslipidemic adolescents: Design of a quadruple-blind, randomized, controlled interventional trial. [2023]
Effects of l-carnitine supplement on serum amyloid A and vascular inflammation markers in hemodialysis patients: a randomized controlled trial. [2015]
10.United Statespubmed.ncbi.nlm.nih.gov
Antiinflammatory effects of L-carnitine supplementation (1000 mg/d) in coronary artery disease patients. [2022]
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