Cardiovascular DiseaseNCT02322203
Effects of Niacin Therapy on Lipoprotein Composition and Function
A study testing Niacin Extended Release in people with Cardiovascular Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Niacin Extended Release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2015to 23 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of the Effects of Niacin Therapy on Lipoprotein Composition and Function
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.
Read more
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.
Read the detailed description
This single center clinical pilot study will investigate the effects of niacin on blood lipids and lipoprotein composition in human subjects who are healthy. Niacin (vitamin B3 or nicotinic acid) is a common nutrient found in many foods and is currently sold over the counter as a nutritional supplement. Extended-release versions of niacin are available over the counter (e.g., Slo-Niacin) or by prescription (Niaspan) and help to alleviate symptoms of flushing associated with larger doses of the vitamin. Studies of the effects of niacin therapy on clinical lipid measures consistently indicate a shift toward a healthier lipoprotein profile with increased HDL-C and decreases in both triglyceride and LDL-C. Despite this favorable shift in lipid profile, cardiovascular outcome studies on patients receiving niacin alone or in combination with statin therapy have resulted in mixed results creating uncertainty of the value of niacin therapy. The proposed study will examine in detail the effects of niacin therapy on lipoprotein composition and function, while also tracking measures of vascular health.
- Conditions
- Cardiovascular Disease
- Being tested
- Niacin Extended Release
- Keywords
- Niacin, Cholesterol, High-Density Lipoprotein, Low-Density Lipoprotein, Lipoproteins
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niacin Extended ReleaseDietary supplement
Also called Niacin Extended Release (ER); Niacin
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Niacin Extended Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change in High-density Lipoprotein Protein Concentration
Measure the mean percentage of niacin monotherapy on high-density lipoprotein (HDL) protein concentration
Measured: 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.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study start25 Mar 2015
- Primary completion7 Apr 2019
- Study completion23 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Marcelo J Amar, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322203
- Sponsor's protocol ID
- 150042
- Other IDs
- 15-H-0042
- Status last verified
- Jul 2020
- First submitted
- 20 Dec 2014
- Last updated
- 14 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Niacin Therapy on Lipoprotein Composition and Function
- ClinicalTrials.gov ID
- NCT02322203
- Acronym / sponsor ID
- 150042
- Conditions
- Cardiovascular Disease
- Keywords
- Niacin, Cholesterol, High-Density Lipoprotein, Low-Density Lipoprotein, Lipoproteins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 25 Mar 2015 (actual)
- Primary completion
- 7 Apr 2019 (actual)
- Study completion
- 23 Jul 2019 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Posted 14 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This single center clinical pilot study will investigate the effects of niacin on blood lipids and lipoprotein composition in human subjects who are healthy. Niacin (vitamin B3 or nicotinic acid) is a common nutrient found in many foods and is currently sold over the counter as a nutritional supplement. Extended-release versions of niacin are available over the counter (e.g., Slo-Niacin) or by prescription (Niaspan) and help to alleviate symptoms of flushing associated with larger doses of the vitamin. Studies of the effects of niacin therapy on clinical lipid measures consistently indicate a shift toward a healthier lipoprotein profile with increased HDL-C and decreases in both triglyceride and LDL-C. Despite this favorable shift in lipid profile, cardiovascular outcome studies on patients receiving niacin alone or in combination with statin therapy have resulted in mixed results creating uncertainty of the value of niacin therapy. The proposed study will examine in detail the effects of niacin therapy on lipoprotein composition and function, while also tracking measures of vascular health.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Niacin ER in healthy participants and its effects on lipoprotein composition and function | Experimental | Dietary Supplement: Niacin Extended ReleaseNiacin 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Niacin Extended ReleaseAlso: Niacin Extended Release (ER); NiacinSubjects 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. | Dietary supplement | Niacin ER in healthy participants and its effects on lipoprotein composition and function |
Primary outcome
Mean Percent Change in High-density Lipoprotein Protein Concentration
Time frame: 20 weeks
Measure the mean percentage of niacin monotherapy on high-density lipoprotein (HDL) protein concentration
Change in Proteins of High-density Lipoprotein Protein Composition on Niacin Monotherapy
Time frame: 20 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo J Amar, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Niacin Extended Release in people with Cardiovascular Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percent Change in High-density Lipoprotein Protein Concentration (time frame: 20 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.