DyslipidemiaPhase 1NOFATNCT01984073
Effects of Niacin On Fatty Acid Trapping
A Phase 1 study testing ER Niacin Oral Fat Challenge and IR Niacin Oral Fat Challenge in people with Dyslipidemia, run by University of Pennsylvania at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- ER Niacin Oral Fat Challenge and IR Niacin Oral Fat Challenge
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2012to Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet protocol defined criteria for atherogenic dyslipidemia phenotype
- Men and non-pregnant, non-lactating women between the ages of 22 and 75
- Fasting triglycerides <500 mg/dL
- Ability to understand and agree to informed consent
- Willingness to comply with study-related procedures
Who cannot join
- Dysbetalipoproteinemia
- History of extreme triglyceridemia (TG >500 mg/dL) or pancreatitis from triglyceridemia, regardless of whether it is currently controlled
- LDL >190 mg/dL
- History of chronic renal insufficiency (serum creatinine >2.0 mg/dL)
- History of non-skin malignancy within the previous 5 years
- Subject reported history of HIV
Show all 26Show fewer
- Uncontrolled thyroid disease
- Hypoalbuminemia (serum albumin >2.5 mg/dL)
- Exposure to an investigational drug within 6 weeks prior to the screening visit
- Any major active rheumatologic, pulmonary, or dermatologic disease or inflammatory condition
- Major surgery within the previous 6 weeks
- Subjects who have undergone any organ transplant
- History of drug abuse within the past 3 years, or regular alcohol use >14 drinks per week
- Women who are breast-feeding
- Women who are pregnant by urine pregnancy test at each visit
- Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
- Change in statin dose within 6 weeks of the first experimental visit
- Use of the following non-statin lipid-altering therapy within 6 weeks of the first experimental visit: Niacin > 100 mg/day (Niacor, Slo-Niacin, Niaspan, Advicor, or supplemental niacin), Fibrates [gemfibrozil (Lopid), fenofibrate (Antara, Lofibra, Tricor, Triglide)], Enterically active drugs [colestipol (Colestid), cholestyramine (Questran), colesevelam (Welchol), ezetimibe (Zetia, Vytorin)], Red yeast rice, Fish oil (Omacor, numerous supplements)
- Use of medications indicated for the treatment of diabetes within 6 weeks of the screening visit
- Known intolerance or contraindication to niacin (e.g., moderate to severe gout, severe peptic ulcer disease)
- Medical condition that would prohibit fasting (e.g., diagnosis of insulinoma or postabsorptive hypoglycemia)
- Significant disinclination to dairy products (e.g., lactose intolerance, inviolable dietary restrictions)
- History of anaphylactic reaction
- For indocyanine green substudy: iodine allergy or shellfish allergy (n.b. a subject with an allergy can participate in the overall experiment, but will forego the indocyanine green tracer study)
- Donation of blood 8 weeks and/or treatment with medications for psychiatric disorders
- Hemoglobin <10 g/dL
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Presbyterian Hospital
Philadelphia, Pennsylvania, 19104
About this study
Official title: Effect of Niacin On Fatty Acid Trapping
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.
Read the 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
- Being tested
- ER Niacin Oral Fat Challenge, IR Niacin Oral Fat Challenge, Placebo Oral Fat Challenge
- Keywords
- Atherogenic dyslipidemia phenotype
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ER Niacin Oral Fat ChallengeDrug
Also called Niaspan
Extended release niacin 2000 mg at hour 0, followed by oral fat challenge at hour 1.
IR Niacin Oral Fat ChallengeDrug
Also called Nialor
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)
Placebo Oral Fat ChallengeOther
Placebo at hour 0. Oral fat challenge at hour 1, followed by placebo at hours 2,4,and 6
| Study group | Role | What they receive |
|---|---|---|
| ER Niacin Oral Fat Challenge | Active comparator | ER Niacin (Niaspan) 2000mg one hour prior to Oral Fat Challenge using fresh cream at a dose of 50 g fat per square meter of body surface area. This is followed by frequent plasma and urine collections for next 12 hours to assess markers of fat metabolism and inflammation. Receives: Drug: ER Niacin Oral Fat Challenge |
| IR Niacin Oral Fat Challenge | Active comparator | Immediate-Release Niacin (Nialor) 500 mg one hour prior to Oral Fat Challenge and again 1, 3 and 5 hours after the oral fat load for a total dose of 2 grams.Subjects will undergo plasma and urine collections for 12 hours to assess markers of fat metabolism and inflammation. Receives: Drug: IR Niacin Oral Fat Challenge |
| Placebo Oral Fat Challenge | Placebo comparator | Placebo one hour before and 1,3, and 5 hours after oral fat load using heavy cream at 50 grams of fat per square meter of body surface area. Plasma and urine collections for 12 hours Receives: Other: Placebo Oral Fat Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Triglycerides
Plasma Triglycerides (TGs) after oral fat challenge will be measured to assess post-prandial lipidemia after niacin and placebo. Parameters of interest are the area under the curve (AUC), time to peak (t-max), and peak concentration (c-max). The relevant units will be mg.h/dl for plasma triglyceride AUC, minutes for time to peak plasma TG and mg/dl for c-max.
Measured: Baseline to 12 hour post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Arizona Pharmaceuticals Inc.
- Responsible party
- Principal investigator, Richard Dunbar, University of Pennsylvania
- Investigators
- Richard L Dunbar, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984073
- Sponsor's protocol ID
- NOFAT
- Other IDs
- K23HL091130
- Acronym
- NOFAT
- Status last verified
- Jul 2020
- First submitted
- 7 Nov 2013
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Niacin On Fatty Acid Trapping
- ClinicalTrials.gov ID
- NCT01984073
- Acronym / sponsor ID
- NOFAT / NOFAT
- Conditions
- Dyslipidemia
- Keywords
- Atherogenic dyslipidemia phenotype
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Arizona Pharmaceuticals Inc.
- Study start
- Dec 2012
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 14 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ER Niacin Oral Fat Challenge | Active comparator | Drug: ER Niacin Oral Fat ChallengeER Niacin (Niaspan) 2000mg one hour prior to Oral Fat Challenge using fresh cream at a dose of 50 g fat per square meter of body surface area. This is followed by frequent plasma and urine collections for next 12 hours to assess markers of fat metabolism and inflammation. |
| IR Niacin Oral Fat Challenge | Active comparator | Drug: IR Niacin Oral Fat ChallengeImmediate-Release Niacin (Nialor) 500 mg one hour prior to Oral Fat Challenge and again 1, 3 and 5 hours after the oral fat load for a total dose of 2 grams.Subjects will undergo plasma and urine collections for 12 hours to assess markers of fat metabolism and inflammation. |
| Placebo Oral Fat Challenge | Placebo comparator | Other: Placebo Oral Fat ChallengePlacebo one hour before and 1,3, and 5 hours after oral fat load using heavy cream at 50 grams of fat per square meter of body surface area. Plasma and urine collections for 12 hours |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meet protocol defined criteria for atherogenic dyslipidemia phenotype
- Men and non-pregnant, non-lactating women between the ages of 22 and 75
- Fasting triglycerides <500 mg/dL
- Ability to understand and agree to informed consent
- Willingness to comply with study-related procedures
Key exclusion criteria (26 listed)
- Dysbetalipoproteinemia
- History of extreme triglyceridemia (TG >500 mg/dL) or pancreatitis from triglyceridemia, regardless of whether it is currently controlled
- LDL >190 mg/dL
- History of chronic renal insufficiency (serum creatinine >2.0 mg/dL)
- History of non-skin malignancy within the previous 5 years
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 |
|---|---|---|
| ER Niacin Oral Fat ChallengeAlso: NiaspanExtended release niacin 2000 mg at hour 0, followed by oral fat challenge at hour 1. | Drug | ER Niacin Oral Fat Challenge |
| IR Niacin Oral Fat ChallengeAlso: NialorNialor(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) | Drug | IR Niacin Oral Fat Challenge |
| Placebo Oral Fat ChallengePlacebo at hour 0. Oral fat challenge at hour 1, followed by placebo at hours 2,4,and 6 | Other | Placebo Oral Fat Challenge |
Primary outcome
Plasma Triglycerides
Time frame: Baseline to 12 hour post dose
Plasma Triglycerides (TGs) after oral fat challenge will be measured to assess post-prandial lipidemia after niacin and placebo. Parameters of interest are the area under the curve (AUC), time to peak (t-max), and peak concentration (c-max). The relevant units will be mg.h/dl for plasma triglyceride AUC, minutes for time to peak plasma TG and mg/dl for c-max.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Richard L Dunbar, MD principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ER Niacin Oral Fat Challenge and IR Niacin Oral Fat Challenge in people with Dyslipidemia, run by University of Pennsylvania at 2 sites 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 5 inclusion and 26 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 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plasma Triglycerides (time frame: Baseline to 12 hour post dose). 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 9 Jul 2020.