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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
My fasting triglyceride levels are between 130 and 500 mg/dL.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Carotid Femoral Pulse Wave Velocity
Secondary outcome measures
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
1,002 Previous Clinical Trials
6,002,694 Total Patients Enrolled
4 Trials studying Metabolic Syndrome
184 Patients Enrolled for Metabolic Syndrome
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,847 Previous Clinical Trials
47,818,160 Total Patients Enrolled
34 Trials studying Metabolic Syndrome
19,460 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May adults of 18 years and older partake in this experiment?

"As outlined in the study parameters, only individuals aged 13-19 are eligible to participate."

Answered by AI

Are researchers interested in enrolling more participants for this investigation?

"As per clinicaltrials.gov, enrollment is currently open for this medical study which was posted on February 1st 2020 and amended November 18th 2021."

Answered by AI

How many subjects are participating in the trial?

"Affirmative. According to clinicaltrials.gov, this investigation was initially advertised on February 1st 2020 and most recently updated November 18th 2021 - indicating it is actively looking for enrollees. 166 individuals are being called upon from one medical centre."

Answered by AI

Am I eligible to be a part of this medical experiment?

"This clinical trial is looking for 166 adolescents between 13 and 19 years old, of all genders and races, who have been diagnosed with metabolic syndrome. The desired patients must also have a fasting serum triglyceride level that falls within the range 130-500 mg/dL as well as an LDL-C lower than 160mg/dL."

Answered by AI

What perils could befall an individual when exposed to CS+?

"CS+'s safety has been partially verified in a Phase 2 trial, thus our team assigned it a score of two. Unfortunately, there is still no clinical data to support its efficacy."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Texas Children's Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I would love to loose weight. I eat healthy and limit my portions with no success.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long is the trial?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Causal Mechanisms in Adolescent Arterial Stiffness
Justin Zachariah 2020. "Causal Mechanisms in Adolescent Arterial Stiffness". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04128969.
All > Metabolic Syndrome
~17 spots leftby May 2025
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