Conditions: Hypercholesterolemia Flushing
Keywords: Niacin Hypercholesterolemia Flushing
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 100
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. arm 2: Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. arm 3: Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. arm 4: Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.

Interventions: intervention 1: Apple pectin intervention 2: Aspirin 325 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Apple pectin 2000mg intervention 2: Aspirin 325 mg intervention 3: Placebo

Protocol document: