Supplements, Placebo, or Rosuvastatin Study

Summary

A research study that is evaluating a low dose of an FDA approved statin medication in comparison to several commercially available over the counter dietary supplements which are marketed for cholesterol health. The study is comparing their effect on LDL cholesterol. LDL-cholesterol is low-density cholesterol and is sometimes referred to as "bad" cholesterol. Participants must live in Ohio and have a documented elevated LDL cholesterol level between 70-189mg/dL, must not currently be taking a statin or one of the dietary supplements included in the trial. Participants willing to discontinue a prohibited supplement for 4 weeks prior to enrollment will be allowed to participate. Trial participation is 4 weeks. Study medication will be provided at no charge. There will be 2 visits which include a lab draw at any Cleveland Clinic laboratory. Participants will be randomized (like a coin flip) to be in one of 8 possible groups: Rosuvastatin, Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice, or placebo. The study will enroll 200 participants.

Timeline

Start

2021-04-23

Primary completion

2022-07-19

Completion

2022-07-19

Publications

• Laffin LJ, Bruemmer D, Garcia M, Brennan DM, McErlean E, Jacoby DS, Michos ED, Ridker PM, Wang TY, Watson KE, Hutchinson HG, Nissen SE. Comparative Effects of Low-Dose Rosuvastatin, Placebo, and Dietary Supplements on Lipids and Inflammatory Biomarkers. J Am Coll Cardiol. 2023 Jan 3;81(1):1-12. doi: 10.1016/j.jacc.2022.10.013. Epub 2022 Nov 6.

Drugs

Indications