Supplements, Placebo, or Rosuvastatin Study
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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.
    

Intervention name(s): Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice; Rosuvastatin; Placebo
Intervention type(s): Dietary Supplement; Drug; Other
Intervention description(s): 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).
Other intervention name(s): Crestor
Intervention MeSH terms: Rosuvastatin Calcium; Red yeast rice
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)
Primary purpose: Treatment
Keywords: LDL & HDL Cholesterol, Statin, Dietary Supplements