Supplements, Placebo, or Rosuvastatin Study
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice; Rosuvastatin; Placebo
Intervention description: Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).; Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).; Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).
Intervention MeSH terms: Rosuvastatin Calcium; Red yeast rice
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible subjects will be randomized 1:1:1:1:1:1:1:1 to the study groups in a blinded fashion. There will be 25 subjects per study group. The total sample size will be 200 patients.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Subjects, investigator staff, persons performing the assessments, and the clinical trial team will be blinded to assigned study group.
Enrollment: 203.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: LDL & HDL Cholesterol, Statin, Dietary Supplements

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.
    

Eligibility criteria:

        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.