Effects of Niacin Therapy on Lipoprotein Composition and Function

NCT02322203 | Completed Results

• 2 other identifiers: 15004215-H-0042
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Cardiovascular Disease

Keywords

Niacin; Cholesterol; High-Density Lipoprotein; Low-Density Lipoprotein; Lipoproteins

Outcome Measures

Primary Outcomes (2)

• Mean Percent Change in High-density Lipoprotein Protein Concentration

  Measure the mean percentage of niacin monotherapy on high-density lipoprotein (HDL) protein concentration

  20 weeks

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

  Measure the effect proteins with changes in protein composition of niacin monotherapy on high-density lipoprotein (HDL) protein composition. High-density lipoprotein protein were measured using Nuclear magnetic resonance (NMR) spectroscopy. NMR spectroscopy is a technique that uses the magnetic properties of atomic nuclei to analyze the chemical and physical properties of molecules or atoms. NMR spectroscopy is non-destructive and non-invasive, and can be used to study the structure, dynamics, and chemical reactions of molecules. NMR procedures numerical results which are comparable to laboratory results, and these data were used to measure the outcomes reported.

  20 weeks

Study Arms (1)

Niacin ER in healthy participants and its effects on lipoprotein composition and function

EXPERIMENTAL

Niacin extended release (ER) to be given as follows: 500 mg/day for 1 week, then 1000 mg/day for 1 week, then 2000 mg/day for 14 weeks in healthy participants.

Dietary Supplement: Niacin Extended Release

Interventions

Niacin Extended Release DIETARY_SUPPLEMENT

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.

Also known as: Niacin Extended Release (ER); Niacin

Niacin ER in healthy participants and its effects on lipoprotein composition and function

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 diabetes or HbA1c greater than 6.5%.
• Volunteers may also be excluded, if in the opinion of the study investigators, they have some other condition or disorder that may adversely affect the outcome of the study or the safety of the volunteer.

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Niacin

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Marcelo J. Amar, M.D. Principal Investigator, NIH, NHLBI
• Organization: National Heart Lung and Blood Institute (NHLBI)

mamar@nhlbi.nih.gov

301.402.0521

Study Officials

• Marcelo J Amar, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Model Details: This novel pilot study will be carried out at the NIH Clinical Center outpatient clinic 7 in healthy volunteers. We will screen up to 200 subjects, males and females, to obtain at least 32 completed studies. Participants will be recruited via flyer, and/or recruitment advertisement placed in the NIH Record, the NHLBI Recruitment website, the Clinical Center News and by email/listserv.

Study Record Dates

• First Submitted: December 20, 2014
• First Posted: December 23, 2014
• Study Start: March 25, 2015
• Primary Completion: April 7, 2019
• Study Completion: July 23, 2019
• Last Updated: March 14, 2025
• Results First Posted: March 14, 2025

Record last verified: 2020-07

Locations

US (1)