NCT01984073

Effects of Niacin On Fatty Acid Trapping

Effect of Niacin On Fatty Acid Trapping

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to understand whether a vitamin called NIcotinic ACid vitamIN (NIACIN for short, also known as vitamin B3) helps the body process dietary fat more efficiently. This is important because people with dyslipidemia have a problem with how they process fat, which raise the risk of heart disease.

Detailed description

This study includes three phases, which each have a separate purpose. At this time, we are only recruiting for Phase 2. The purpose of this particular phase is to measure the effects of niacin after drinking a glass of heavy cream as a source of fat. We hope that studying the way the body responds will help us better understand how niacin works. In this study, we are interested in niacin's ability to lower triglycerides, or fat in the blood. We are studying two different forms of niacin and comparing them to each other. The two forms differ in how long they take to release niacin into the bloodstream. The first form is called Nialor, and is sometimes called immediate-release niacin because it is absorbed into the bloodstream quickly. The second form is called Niaspan, and is sometimes called extended-release niacin because it is a time-released spansule that takes longer to get into the bloodstream. We are comparing the two forms because we think that the time that it takes to absorb niacin may affect how it works. We also want to understand one of the common effects of niacin: skin flushing. Most people who take niacin experience flushing, which is a hot flash. In this study, we are studying whether the two forms of niacin cause different degrees of flushing. Niaspan is approved by the US Food and Drug Administration (FDA) to treat unfavorable cholesterol levels and prevent heart attacks in those who have already suffered heart attacks. Nialor is available over the counter as a supplement and contains Silymarin (milk thistle) and Policosanol (an extract from sugar cane) in addition to niacin.

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
DRUG	ER Niacin Oral Fat Challenge	Extended release niacin 2000 mg at hour 0, followed by oral fat challenge at hour 1.
DRUG	IR Niacin Oral Fat Challenge	Nialor(R) 500mg or Placebo at hour 0, 2, 4, and 6. Oral fat challenge at hour 1 (one hour after first dose of immediate-release niacin)
OTHER	Placebo Oral Fat Challenge	Placebo at hour 0. Oral fat challenge at hour 1, followed by placebo at hours 2,4,and 6

Timeline

• Start date: 2012-12-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2013-11-14
• Last updated: 2020-07-09

Locations

2 sites across 1 country: United States