CLINICAL TRIAL

Choline for Cardiovascular Risk

Recruiting · 18+ · All Sexes · Blacksburg, VA

This study is evaluating whether a metabolite produced by gut microbial metabolism of dietary choline may have negative impacts for individuals with cardiovascular disease.

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About the trial for Cardiovascular Risk

Treatment Groups

This trial involves 2 different treatments. Choline is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Choline
DIETARYSUPPLEMENT
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
DIETARYSUPPLEMENT

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Choline
2015
Completed Phase 3
~510

Eligibility

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
18-65 years old, healthy, non-smoking weight stable for previous 6 months (±2.0 kg), BMI<35 kg/m^2, verbal and written informed consent, approved for participation by study medical director (Jose Rivero, M.D.)
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 45-minute measurement in laboratory
Screening: ~3 weeks
Treatment: Varies
Reporting: 45-minute measurement in laboratory
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 45-minute measurement in laboratory.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Choline will improve 1 primary outcome and 2 secondary outcomes in patients with Cardiovascular Risk. Measurement will happen over the course of 5-minute measurement in laboratory.

Change in gut-mediated TMAO levels after supplementation
5-MINUTE MEASUREMENT IN LABORATORY
At baseline, a fasting blood sample will be collected to measure plasma TMAO concentration after supplementation consumption 8 hours prior to the third testing session.
5-MINUTE MEASUREMENT IN LABORATORY
Change in brachial artery function after supplementation
30-MINUTE MEASUREMENT IN LABORATORY
Brachial artery function or flow mediated dilation (FMD), the blood flow and diameter of the brachial artery in the forearm (fMD), will be measured using a duplex ultrasound machine before and after the inflation of a blood pressure cuff on the forearm for 5 minutes and after placing a nitroglycerine tablet (0.4 mg) under the participant's tongue. This test will be conducted once at baseline and then once after each 5-day period of the randomly-assigned supplement (choline or placebo), including a 1-week washout period (crossover design). Off-line analysis of baseline and post-reactive hyperemic diameters and velocities will be performed using edge detection software (Vascular Analysis Tools, Medical Imaging Applications, Inc.).
30-MINUTE MEASUREMENT IN LABORATORY
Change in arterial stiffness after supplementation
45-MINUTE MEASUREMENT IN LABORATORY
The blood flow and diameter in the common arteries in the neck will be measured from the image obtained from an ultrasound unit (GE Vivid S6) equipped with a high resolution linear array transducer. For applanation tonometry, the carotid, brachial, radial and femoral artery pressure waveform and amplitude will be obtained by a fingertip probe incorporating a high-fidelity strain gauge transducer. Each of these measures are used to calculate arterial stiffness. These tests will be conducted once at baseline and then once after each 5-day period of the randomly-assigned supplement (choline or placebo), including a 1-week washout period (crossover design).
45-MINUTE MEASUREMENT IN LABORATORY

Who is running the study

Principal Investigator
K. D.
Prof. Kevin Davy, Professor
Virginia Polytechnic Institute and State University

Patient Q & A Section

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

What are common treatments for cardiovascular risk?

There are several types of medication, including statins and beta blockers. Most people have a combination of treatments for cardiovascular risk that are better than the risks alone.

Anonymous Patient Answer

What is cardiovascular risk?

There is a significant association between elevated cardiometabolic risk and the accumulation of depressive symptoms in an older and at-risk population. This suggests that it may be important from a public health perspective to identify and treat patients with depressive symptoms and to reduce the risk of CVD events by limiting the accumulation of risk factors and reducing depressive symptoms, and the risk of CVD events and all-cause mortality in older patients.

Anonymous Patient Answer

What are the signs of cardiovascular risk?

The risks of cardiovascular diseases in patients affected by systemic lupus erythematosus (SLE) have been shown by recent epidemiological studies. This implies that SLE is a new risk factor for developing CAD.

Anonymous Patient Answer

Can cardiovascular risk be cured?

Patients with normal cardiovascular risk factors are unlikely to benefit from health interventions. While there may be an increased CV risk in individuals with high CVD risk, a number of studies were unable to show any benefit in preventing adverse CV outcomes.

Anonymous Patient Answer

How many people get cardiovascular risk a year in the United States?

Around 5 million individuals die a year due to cardiovascular events in the United States, and an additional 16 million American adults will die from cardiovascular or cardiac complications during their lifetimes.

Anonymous Patient Answer

What causes cardiovascular risk?

For the majority of people, the only risk factor for developing cardiovascular disease is a combination of age and risk factors other than blood pressure. However, for a high percentage of those with cardiovascular diseases, blood pressure is also a risk factor for the disease. In the future, prevention measures which are tailored to the population’s risk factors can reduce cardiovascular disease.

Anonymous Patient Answer

How serious can cardiovascular risk be?

Cardiovascular risk could be a problem if one does not take the necessary steps to manage the risk on a life-long bases. Physicians will always help a person with their cardiovascular risks by educating them on lifestyle changes such as a healthy diet and regular exercise. If the patient wants to reduce his or her risk, they can check their blood pressure and heart-rate regularly by taking their blood pressure with a stethoscope when they get up each day. If a patient refuses to be active in their life, they can consult their doctor and take other lifestyle changes such as smoking cessation and avoiding alcohol. At the same time, an active lifestyle can reduce one's risk of heart disease in the future by promoting heart health.

Anonymous Patient Answer

Does choline improve quality of life for those with cardiovascular risk?

A dietary supplement containing choline and folic acid results in improved HRQOL in subjects with CVD risk, independent of change in cardiovascular risk factors. Choline decreases the risk of cardiovascular disease by increasing the levels of HDL.

Anonymous Patient Answer

Have there been any new discoveries for treating cardiovascular risk?

Cardiovascular risk has continued to increase in both Western and Eastern societies which poses a great challenge for medical practitioners. Recent advances in genetics and genomics were able to assist in the diagnosis of disease and are likely to play an increasingly important role in the future of preventive medicine; and in addition offer novel therapeutic strategies for the treatment of risk, for example, pharmacogenetics can be used to identify individual risk profiles for a group of people of different ethnic backgrounds and thus identify those with low (or high) risk, who may benefit from a more strict control of their blood cholesterol.\nHowever recent research has revealed new opportunities for cardiovascular disease (CVD) prevention.

Anonymous Patient Answer

What are the common side effects of choline?

Choline seems rather a mixture of molecules rather than a specific chemical. Common side effects depend on whether choline is taken orally or by injection. For patients treated intravenously, common side effects are muscle pain, dizziness, or headache. In patients treated orally, people typically complain about nausea, vomiting, abdominal pain, or diarrhea. People with liver damage should be alert for jaundice. If people start taking choline and develop an overdose, a medical emergency should be suspected. Symptoms of choline overdose include excessive excitement, blurred vision, shortness of breath, confusion, and depression. In rare cases, people have developed an acute respiratory distress syndrome after choline.

Anonymous Patient Answer

What does choline usually treat?

Choline supplementation appears to improve HDL quality and may improve insulin-mediated glucose uptake and lipid oxidation in human skeletal muscle. Additionally, choline improves oxidative phosphorylation by increasing the concentration of [PCr] (phosphoenolpyruvic acid-3-phosphate), reducing [PEP] (pyruvate, phosphate dikinase complex), improving [ATP] (adenosine triphosphate), and activating ATPase by a novel mechanism. Choline supplementation in obese, middle-aged women did not affect serum or ectopic fat. In a recent study, findings support the use of [cognitive training] (e.g.

Anonymous Patient Answer

Has choline proven to be more effective than a placebo?

While the difference between choline and a placebo is small, the results are consistent with those published at this institution and were statistically significant. Further studies will be needed to determine whether a larger dose of choline should be tested.

Anonymous Patient Answer
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