Supplements, Placebo, or Rosuvastatin Study
Supplements, Placebo, or Rosuvastatin Study
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.
Few well-controlled trials have studied the LDL-lowering effects of dozens of marketed
 "cholesterol health" dietary supplements. Prior research suggests most U.S. consumers believe
 cholesterol health supplements are safer than statins, and a majority of the public also
 believe supplements are as effective, or more effective, than prescription statins.
 Approximately one third of US adults who have been told they have elevated cholesterol are
 using a supplement to provide heart health protection rather than a statin. This represents a
 significant public health concern.

 The purpose of this study is to evaluate the effect of select dietary supplements on
 cholesterol health compared with a low dose of a statin.

 The study is comparing their effect on LDL and HDL cholesterol and inflammatory markers.

 A randomized, single blind study design will be used to evaluate rosuvastatin 5 mg. vs.
 placebo and 6 commercially available over the counter supplements in a hierarchical testing
 order. Each participant will take study medication/supplement for a total of 4 weeks.

 The study will randomize primary prevention patients who are considered borderline and
 intermediate risk for ASCVD based upon the 2018 Cholesterol Treatment Guidelines7 and are not
 taking any of the studied medication/supplements at the time of randomization.

 Participants must 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. 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.
Inclusion Criteria:

 1. Written informed consent must be obtained before any assessment is performed.

 2. U.S. adults with primary hypercholesterolemia, 40-75 years of age.

 3. Not currently taking statins or one of the dietary supplements included in the trial.
 Patients willing to discontinue a prohibited supplement for 4 weeks prior to
 enrollment will be allowed to participate.

 4. LDL-cholesterol between 70 and 189 mg/dL.

 5. Patients without diabetes mellitus and a 10-year risk of ASCVD between 5 and <20%
 using the pooled cohort risk equation. * Or Patients with diabetes mellitus in females
 50-60 years of age or males 40-50 years of age with an LDL-C between 70-189 mg/dL and
 with an ASCVD risk below 20%.

 Exclusion Criteria:

 1. Age < 40 or >75 years of age

 2. Women who are pregnant, plan to become pregnant within the next 6 months, or are
 breastfeeding.

 3. Documented liver dysfunction or history of elevated LFTs indicating active liver
 disease

 4. Documented chronic renal dysfunction within the past two years defined as an
 eGFR<30mL/min/m2.

 5. Known hypersensitivity to rosuvastatin or any supplement under investigation (i.e.
 shellfish allergy, etc.).

 6. Currently taking any prescription statin, or other prescription medication/supplements
 to treat elevated cholesterol or triglycerides.

 7. Currently taking a medication/supplement that has known interaction with rosuvastatin,
 including fenofibrate, gemfibrozil, HIV medications, colchicine, cyclosporine,
 warfarin, anti-viral medications to treat Hepatitis C, regorafenib, and darolutamide.

 8. Are unwilling to discontinue prohibited dietary supplement(s) for 4 weeks prior to
 participation or during the course of the trial. Other non-prohibited supplements will
 be permitted if doses have been stable for at least 4 weeks.

 9. Known cardiovascular disease including a history of prior MI, stroke/TIA, PAD or prior
 revascularization procedures of the heart or vasculature (e.g. CABG, stenting, PCI
 etc.).

 10. Fasting Triglycerides >200mg/dl.

 11. In the opinion of the investigator, any other condition that will preclude
 participation in the study.