Supplements, Placebo, or Rosuvastatin Study

NCT ID: NCT04846231

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-23
• Study Completion Date: 2022-07-19

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Rosuvastatin

5 mg once per day

Group Type: ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type: DRUG

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).

Placebo

comparable to rosuvastatin 5 mg once per day

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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).

Fish Oil

Nature Made 2 soft gels per day

Group Type: ACTIVE_COMPARATOR

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice

Intervention Type: DIETARY_SUPPLEMENT

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).

Cinnamon

1200mg, 2 capsules per day

Group Type: ACTIVE_COMPARATOR

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice

Intervention Type: DIETARY_SUPPLEMENT

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).

Garlique

Manufactured by Focus Consumer Health Marketgate,1 tablet per day

Group Type: ACTIVE_COMPARATOR

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice

Intervention Type: DIETARY_SUPPLEMENT

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).

Turmeric

Bio Schwartz Turmeric Curcumin 1500 mg, 3 capsules per day

Group Type: ACTIVE_COMPARATOR

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice

Intervention Type: DIETARY_SUPPLEMENT

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).

Plant Sterol

Nature Made CholestOff Plus, 2 soft gels twice a day

Group Type: ACTIVE_COMPARATOR

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice

Intervention Type: DIETARY_SUPPLEMENT

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).

Red Yeast Rice

Arazo Nutrition 1200 mg, 2 capsules per day

Group Type: ACTIVE_COMPARATOR

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice

Intervention Type: DIETARY_SUPPLEMENT

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).

Interventions

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).

Intervention Type: DIETARY_SUPPLEMENT

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).

Intervention Type: DRUG

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).

Intervention Type: OTHER

Other Intervention Names

Crestor

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luke Laffin, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Steven Nissen, M.D.

Role: STUDY_CHAIR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36351465 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Version 1.0 23February2021

Identifier Type: -

Identifier Source: org_study_id