Cardiovascular Disease
Conditions
Keywords
Niacin, Cholesterol, High-Density Lipoprotein, Low-Density Lipoprotein, Lipoproteins
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.
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.
Interventions
DIETARY_SUPPLEMENTNiacin 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
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change in High-density Lipoprotein Protein Concentration | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Niacin ER in Healthy Participants and Its Effects on Lipoprotein Composition and Function 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. | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | Niacin ER in Healthy Participants and Its Effects on Lipoprotein Composition and Function |
|---|---|
| Age, Continuous | 38.5 years STANDARD_DEVIATION 13.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 22 |
| other Total, other adverse events | 5 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
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.
Time frame: 20 weeks
Population: Out of the 14 participants that completed study, 3 participants were considered to be non-responders and not included in data analysis. Therefore, 11 participants were included in data analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Niacin ER in Healthy Participants and Its Effects on Lipoprotein Composition and Function | Change in Proteins of High-density Lipoprotein Protein Composition on Niacin Monotherapy | 5 proteins |
Primary
Mean Percent Change in High-density Lipoprotein Protein Concentration
Measure the mean percentage of niacin monotherapy on high-density lipoprotein (HDL) protein concentration
Time frame: 20 weeks
Population: Out of the 14 participants that completed study, 3 participants were considered to be non-responders and not included in data analysis. Therefore, 11 participants were included in data analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin ER in Healthy Participants and Its Effects on Lipoprotein Composition and Function | Mean Percent Change in High-density Lipoprotein Protein Concentration | High-density lipoprotein cholesterol | 16.0 Percentage Change | Standard Deviation 11.1 |
| Niacin ER in Healthy Participants and Its Effects on Lipoprotein Composition and Function | Mean Percent Change in High-density Lipoprotein Protein Concentration | Low-density lipoprotein cholesterol | -20.0 Percentage Change | Standard Deviation 24.7 |
| Niacin ER in Healthy Participants and Its Effects on Lipoprotein Composition and Function | Mean Percent Change in High-density Lipoprotein Protein Concentration | Triglyceride | -15.0 Percentage Change | Standard Deviation 21.2 |
| Niacin ER in Healthy Participants and Its Effects on Lipoprotein Composition and Function | Mean Percent Change in High-density Lipoprotein Protein Concentration | Total Cholesterol | -11.0 Percentage Change | Standard Deviation 13.2 |