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Effects of Niacin Therapy on Lipoprotein Composition and Function

NCT02322203 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-03-14

Study results available
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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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Niacin Extended Release

Subjects will receive a 2 week supply of the dietary supplement Rugby Extended Release Niacin (250 mg/tablet) Niacin and will be instructed to take 2 tablets per day (500 mg/day) for the first seven days and then increase to 4 tablets per day (1000 mg/day) during the following 7 days. Subjects will then be escalated to 2000 mg/day for 14 weeks.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Marcelo J Amar, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-25
Primary Completion
2019-04-07
Completion
2019-07-23

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02322203 on ClinicalTrials.gov