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Dietary Supplement

Carnitine Supplementation for Arterial Stiffness

Phase 2
Recruiting
Led By Justin P Zachariah, MD MPH
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Fasting serum triglyceride levels over 130 and less than 500 mg/dL
Be younger than 65 years old
Must not have
Congenital heart disease requiring surgical or catheterization intervention
Known metabolic disorders that require carnitine therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month
Awards & highlights

Summary

This trial will study whether taking a protein supplement called carnitine can help prevent heart disease by reducing arterial stiffness.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects aren't specified here but generally supplements like carnitine could cause digestive upset, fishy body odor, muscle weakness in people with low thyroid function (hypothyroidism), increased seizure risk in those who already have seizures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My fasting triglyceride levels are between 130 and 500 mg/dL.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a heart condition from birth that needed surgery or a catheter procedure.
Select...
I need carnitine therapy for my metabolic disorder.
Select...
I am on dialysis or have had a kidney transplant due to renal failure.
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I have diabetes (type 1 or 2).
Select...
I have a known seizure disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Carotid Femoral Pulse Wave Velocity
Secondary study objectives
Change in Fasting Triglyceride
Change in Insulin Resistance

Trial Design

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+.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,018 Previous Clinical Trials
6,031,339 Total Patients Enrolled
4 Trials studying Metabolic Syndrome
184 Patients Enrolled for Metabolic Syndrome
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,889 Previous Clinical Trials
47,834,117 Total Patients Enrolled
35 Trials studying Metabolic Syndrome
19,720 Patients Enrolled for Metabolic Syndrome
Justin P Zachariah, MD MPHPrincipal InvestigatorStudy Principal Investigator

Media Library

CS- (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04128969 — Phase 2
Metabolic Syndrome Research Study Groups: Carnitine supplementation (CS+), Placebo (CS-)
Metabolic Syndrome Clinical Trial 2023: CS- Highlights & Side Effects. Trial Name: NCT04128969 — Phase 2
CS- (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04128969 — Phase 2
Metabolic Syndrome Patient Testimony for trial: Trial Name: NCT04128969 — Phase 2
~11 spots leftby May 2025
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