CompletedNot Applicable

Effects of Niacin Therapy on Lipoprotein Composition and Function

United States22 participantsStarted 2015-03-25

Plain-language summary

Background: \- Niacin is a vitamin in many foods, including meats, fish, fruits, and vegetables. It is often used as a dietary supplement that causes many improvements in the body. Researchers think it can affect heart health. Objective: \- To better understand the good effects of niacin supplementation on cholesterol, fat metabolism, and vascular health. Eligibility: \- Adults 18 years of age and older with fasting good cholesterol (HDL-C) below 60 mg/dL. Design: * Participants will come to the clinic 4 times during the study. * They will complete a 7-day food journal before visits 1 and 3. * At visit 1, participants will be screened with questions about their diet and exercise, medical history, and any drugs and vitamins they take. Vital signs and body mass index will be measured. * They will have a Cardio-Ankle Vascular Index (CAVI) test of the arteries. Blood pressure will be taken in the arms and legs and the heart will be monitored. * Blood will be drawn. Participants will fast for 8 12 hours before this. * Women will have a pregnancy test. * Eligible participants will get a 2-week supply of niacin. They will take 2 tablets daily for one week, then 4 daily. * Visit 2 will be 2 weeks after visit 1 and the niacin dose will be increased. Visit 3 will be 16 weeks after visit 1, and participants will stop taking niacin. Visit 4 will be 4 6 weeks after stopping niacin. * During study visits, participants will repeat visit 1 tests.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: * Males and females who are at least 18 years of age at time of enrollment. * Subject understands the investigational nature of the study and provides written, informed consent. EXCLUSION CRITERIA: * Subjects taking any lipid modification therapy, including but not limited to statins, fibrates and bile acid sequestrants. * Subjects taking fish oil or any other supplements, which in the investigator s opinion may interfere with the study. * Subjects with acute liver disease or active peptic ulcer disease. * Subjects with elevated uric acid levels greater than 10 mg/dL or gout * Pregnancy or women currently breastfeeding. * Female subjects taking hormonal contraceptives or hormone replacement therapy may be included in this study only if they have been on a stable dose for at least 3 months. * BMI less than 18.5 * Subjects with weight that varies greater than 20% over the past 3 months. * Subjects taking the following medications for at least six weeks, which may interfere with the study, will be excluded: BAS, antibiotics, anticoagulants, anticonvulsants, antiarrhythmic, Cyclosporine, Mycophenolate and Synthroid. Subjects with chronic diarrhea, gastric bypass or lap band procedures, ostomies, bowel motility problems, or other conditions that could affect intestinal fat absorption. * Subjects initiating new medications or patients on multiple medications may also be excluded. * Inability to swallow capsules * Patients with a history of type I or type II …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Percent Change in High-density Lipoprotein Protein Concentration

Timeframe: 20 weeks

Change in Proteins of High-density Lipoprotein Protein Composition on Niacin Monotherapy

Timeframe: 20 weeks

Trial details

NCT IDNCT02322203

SponsorNational Heart, Lung, and Blood Institute (NHLBI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2019-04-07

Results submitted2024-10-07

View on ClinicalTrials.gov More Cardiovascular Disease trials