Conditions: Healthy
Keywords: Healthy Volunteers
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 11
Healthy volunteers: yes

Brief summary:
This is a research study of how a cholesterol medication known as fenofibrate works differently in people with different genetic backgrounds. "Genetics" refers to certain things that are passed to a person by their parents, such as eye color or hair color. Genetic differences lead to people having different eye and hair color. There are also genetic differences in a protein called liver X receptor-alpha (LXRA), which may be important in predicting the response to fenofibrate.

Detailed description:
This is a double blind crossover study of fenofibrate vs. placebo in healthy volunteers. The null hypothesis is that over a four week period, fenofibrate (160mg/day orally) is equivalent to placebo in terms of relative changes in cytokines ENA-78 and MCP-1 over a four week periods, separated by a four week washout. ENA-78 is a marker of inflammation. See http://en.wikipedia.org/wiki/CXCL5 for more details.

Arms:
arm 1: 4 weeks of drug at 160 mg orally per day, 4 week washout, then 4 weeks of placebo arm 2: 4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.

Interventions: intervention 1: Fenofibrate capsule daily for 4 weeks intervention 2: Fenofibrate
Intervention descriptions: intervention 1: Placebo capsule daily for 4 weeks intervention 2: 160 mg/day orally for 4 weeks

Protocol document: