NCT04846231

Supplements, Placebo, or Rosuvastatin Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fish Oil, Cinnamon, Garlique,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).
DRUG	Rosuvastatin	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	Placebo	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).

Timeline

• Start date: 2021-04-23
• Primary completion: 2022-07-19
• Completion: 2022-07-19
• First posted: 2021-04-15
• Last updated: 2023-05-25
• Results posted: 2023-05-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study