Alternative Options to Minimize Niacin-Induced Flushing

Not Applicable

Completed

Brief Summary: Niacin (Vitamin B3) is known to effectively and safely treat hypercholesterolemia. However, use of niacin is limited due to incidents of flushing which limits its acceptability. Some information suggests that applesauce can reduce the incidence and severity of flushing. The apple pectin in particular is thought to be the ingredient that affects this reaction. To determine if the apple pectin does affect flushing from niacin, the investigators will study the affects of isolated apple pectin in pill form. The investigators plan on recruiting 100 patients, and giving them 1000 mg of Niacin to induce flushing. Patients will be divided into 4 treatment groups and receive either pectin, aspirin, a combination of both, or placebo. Incidents and severity of flushing will be monitored for up to 6 hours post Niacin ingestion.

Recruitment & Eligibility

Inclusion Criteria

An adult between 21 and 70 years of age.
Male or female (If female must be postmenopausal for at least 1 year, surgically sterile or using an effective form of contraception).
Able to speak and read English.
Willing to comply with study specific instructions, and complete all study procedures according to protocol.
Able to understand study rationale and sign informed consent.

Exclusion Criteria

Females of child-bearing potential not using acceptable method of contraception and perimenopausal females.
History of gout
History of diabetes mellitus
History of coronary heart disease
History of, or currently experiencing, renal disease including, but not limited to, renal insufficiency, nephrolithiasis or chronic renal failure.
History of, or currently experiencing, major chronic gastrointestinal condition including gallbladder disease, liver disease and peptic ulcer disease
Known sensitivity to niacin, Aspirin or nonsteroidal anti-inflammatory agents (NSAIDs)
History of migraine or cluster headaches
Currently using antihistamines, aspirin or NSAIDS on a consistent basis
Presence or history of any medical or psychosocial condition that, in the opinion of the investigator, would limit the patient's successful participation or would compromise the patient's safe participation.
Lab abnormalities at screening, including but not limited to elevated liver enzymes or blood sugar levels that might indicate additional risk to the patient's continued participation.
Currently taking medication that might be contraindicated with the study drug or Niacin or study procedures (including Niacin, lipid-lowering drugs, chronic aspirin or laxative use).
Clinically significant finding from physical exam that would affect the patient's safe participation or completion of the study.

Arm && Interventions

Group	Intervention	Description
Apple-pectin 2000mg	Apple pectin	Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Regular Non-enteric coated aspirin 325mg	Aspirin 325 mg	Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Apple pectin + aspirin	Apple pectin	Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Apple pectin + aspirin	Aspirin 325 mg	Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Placebo Comparator	Placebo	Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.

Primary Outcome Measures

Name	Time	Method
Incidence of Flushing	Hourly for 6 hours on day of dosing	Flushing assessment performed hourly for 6 hours after niacin administration. Incidence of flushing based on if the participant experience any niacin-induced flushing during the 6 hour period after dosing. Represents # of participants that experienced event.
Time to Flushing	6 hours after dosing	The time it took, in minutes, for a participant to experience any flushing. Time to flush for individuals that did not experience flushing within 6 hours was set to 360 minutes.
Duration of Flushing	6 hours after dosing	The amount of time, in minutes, that flushing lasted. Duration of individuals without experience flushing within 6 hours was set to 0 minutes.
Maximum Flushing Severity Score	6 hours after dosing	Flushing assessment performed hourly for six hours. Assessment of severity done using the validated visual analog scale (VAS) flushing assessment tool (FAST). Severity rated using a VAS from mild (1-3), moderate (4-6), severe (7-9) to very severe (10). The maximum severity score was the maximum severity score of each individual during the 6 hours of monitoring time period.