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Effects of Niacin On Fatty Acid Trapping (NOFAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01984073
Recruitment Status : Completed
First Posted : November 14, 2013
Last Update Posted : July 9, 2020
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Arizona Pharmaceuticals Inc.
Information provided by (Responsible Party):
Richard Dunbar, University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE November 7, 2013
First Posted Date  ICMJE November 14, 2013
Last Update Posted Date July 9, 2020
Study Start Date  ICMJE December 2012
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 7, 2013)
Triglycerides [ Time Frame: Baseline to 12 hour post dose ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Niacin On Fatty Acid Trapping
Official Title  ICMJE Effect of Niacin On Fatty Acid Trapping
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Dyslipidemia
Intervention  ICMJE
  • Drug: ER Niacin Oral Fat Challenge
    Extended release niacin 2000 mg at hour 0, followed by oral fat challenge at hour 1.
    Other Name: Niaspan
  • Drug: IR Niacin Oral Fat Challenge
    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)
    Other Name: Nialor
  • Other: Placebo Oral Fat Challenge
    Placebo at hour 0. Oral fat challenge at hour 1, followed by placebo at hours 2,4,and 6
Study Arms  ICMJE
  • Active Comparator: ER Niacin Oral Fat Challenge
    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.
    Intervention: Drug: ER Niacin Oral Fat Challenge
  • Active Comparator: IR Niacin Oral Fat Challenge
    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.
    Intervention: Drug: IR Niacin Oral Fat Challenge
  • Placebo Comparator: Placebo Oral Fat Challenge
    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
    Intervention: Other: Placebo Oral Fat Challenge
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2020)
26
Original Estimated Enrollment  ICMJE
 (submitted: November 7, 2013)
20
Actual Study Completion Date  ICMJE December 2019
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01984073
Other Study ID Numbers  ICMJE NOFAT
K23HL091130 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Richard Dunbar, University of Pennsylvania
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Pennsylvania
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Arizona Pharmaceuticals Inc.
Investigators  ICMJE
Principal Investigator: Richard L Dunbar, MD University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP