Supplements, Placebo, or Rosuvastatin Study (SPORT)

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: Rosuvastatin; Other: Placebo; Dietary supplement: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice

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.

• Study Type: Interventional
• Enrollment (Actual): 203
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rosuvastatin; 5 mg once per day	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 Names: Crestor
Placebo Comparator: Placebo; comparable to rosuvastatin 5 mg once per day	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).
Active Comparator: Fish Oil; Nature Made 2 soft gels per day	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).
Active Comparator: Cinnamon; 1200mg, 2 capsules per day	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).
Active Comparator: Garlique; Manufactured by Focus Consumer Health Marketgate,1 tablet per day	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).
Active Comparator: Turmeric; Bio Schwartz Turmeric Curcumin 1500 mg, 3 capsules per day	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).
Active Comparator: Plant Sterol; Nature Made CholestOff Plus, 2 soft gels twice a day	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).
Active Comparator: Red Yeast Rice; Arazo Nutrition 1200 mg, 2 capsules per day	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement.	The primary objective of this study is to compare the LDL lowering of rosuvastatin with the effect of six commonly used dietary supplements on cholesterol health.	The percent change in LDL-C for rosuvastatin 5 mg compared with dietary supplements after 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements.	Assess the effect of each supplement on inflammatory markers compared with rosuvastatin 5 mg.	The percent change in high sensitivity C reactive protein (hsCRP) for rosuvastatin 5 mg and dietary supplements compared with placebo after 4 weeks.
Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements.	The percent change in HDL-C, total cholesterol, and triglycerides for each supplement compared with rosuvastatin. The percent change in HDL-C, total cholesterol, and triglycerides for each supplement compared with rosuvastatin. The percent change in HDL-C, total cholesterol, and triglycerides for each supplement compared with placebo.	After 4 weeks
The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements.	The percent change in HDL-C, total cholesterol, and triglycerides for each supplement compared with placebo.	After 4 weeks

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Luke Laffin, M.D., The Cleveland Clinic; Study Chair: Steven Nissen, M.D., The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2021
• Primary Completion (Actual): July 19, 2022
• Study Completion (Actual): July 19, 2022

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: LDL & HDL Cholesterol, Statin, Dietary Supplements
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium; Red yeast rice
• Other Study ID Numbers: Version 1.0 23February2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No