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Supplements, Placebo, or Rosuvastatin Study (SPORT)

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

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

Rosuvastatin

Placebo

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring LDL & HDL Cholesterol, Statin, Dietary Supplements

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent must be obtained before any assessment is performed.
U.S. adults with primary hypercholesterolemia, 40-75 years of age.
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.
LDL-cholesterol between 70 and 189 mg/dL.
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:

Age < 40 or >75 years of age
Women who are pregnant, plan to become pregnant within the next 6 months, or are breastfeeding.
Documented liver dysfunction or history of elevated LFTs indicating active liver disease
Documented chronic renal dysfunction within the past two years defined as an eGFR<30mL/min/m2.
Known hypersensitivity to rosuvastatin or any supplement under investigation (i.e. shellfish allergy, etc.).
Currently taking any prescription statin, or other prescription medication/supplements to treat elevated cholesterol or triglycerides.
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.
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.
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.).
Fasting Triglycerides >200mg/dl.
In the opinion of the investigator, any other condition that will preclude participation in the study.

Sites / Locations

Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Rosuvastatin

Placebo

Fish Oil

Cinnamon

Garlique

Turmeric

Plant Sterol

Red Yeast Rice

Arm Description

5 mg once per day

comparable to rosuvastatin 5 mg once per day

Nature Made 2 soft gels per day

1200mg, 2 capsules per day

Manufactured by Focus Consumer Health Marketgate,1 tablet per day

Bio Schwartz Turmeric Curcumin 1500 mg, 3 capsules per day

Nature Made CholestOff Plus, 2 soft gels twice a day

Arazo Nutrition 1200 mg, 2 capsules per day

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements.

Assess the effect of each supplement on inflammatory markers compared with rosuvastatin 5 mg.

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.

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.

Full Information

NCT ID

NCT04846231

First Posted

April 12, 2021

Last Updated

May 24, 2023

Sponsor

The Cleveland Clinic

Collaborators

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT04846231

Brief Title

Supplements, Placebo, or Rosuvastatin Study

Acronym

SPORT

Official Title

Supplements, Placebo, or Rosuvastatin Study

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

April 23, 2021 (Actual)

Primary Completion Date

July 19, 2022 (Actual)

Study Completion Date

July 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Cleveland Clinic

Collaborators

AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

Keywords

LDL & HDL Cholesterol, Statin, Dietary Supplements

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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

ParticipantCare ProviderInvestigator

Masking Description

Subjects, investigator staff, persons performing the assessments, and the clinical trial team will be blinded to assigned study group.

Allocation

Randomized

Enrollment

203 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rosuvastatin

Arm Type

Active Comparator

Arm Description

5 mg once per day

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

comparable to rosuvastatin 5 mg once per day

Arm Title

Fish Oil

Arm Type

Active Comparator

Arm Description

Nature Made 2 soft gels per day

Arm Title

Cinnamon

Arm Type

Active Comparator

Arm Description

1200mg, 2 capsules per day

Arm Title

Garlique

Arm Type

Active Comparator

Arm Description

Manufactured by Focus Consumer Health Marketgate,1 tablet per day

Arm Title

Turmeric

Arm Type

Active Comparator

Arm Description

Bio Schwartz Turmeric Curcumin 1500 mg, 3 capsules per day

Arm Title

Plant Sterol

Arm Type

Active Comparator

Arm Description

Nature Made CholestOff Plus, 2 soft gels twice a day

Arm Title

Red Yeast Rice

Arm Type

Active Comparator

Arm Description

Arazo Nutrition 1200 mg, 2 capsules per day

Intervention Type

Dietary Supplement

Intervention Name(s)

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

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).

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin

Other Intervention Name(s)

Crestor

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).

Intervention Type

Other

Intervention Name(s)

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).

Primary Outcome Measure Information:

Title

Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement.

Description

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.

Time Frame

The percent change in LDL-C for rosuvastatin 5 mg compared with dietary supplements after 4 weeks

Secondary Outcome Measure Information:

Title

Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements.

Description

Assess the effect of each supplement on inflammatory markers compared with rosuvastatin 5 mg.

Time Frame

The percent change in high sensitivity C reactive protein (hsCRP) for rosuvastatin 5 mg and dietary supplements compared with placebo after 4 weeks.

Title

Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements.

Description

Time Frame

After 4 weeks

Title

The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements.

Description

The percent change in HDL-C, total cholesterol, and triglycerides for each supplement compared with placebo.

Time Frame

After 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent must be obtained before any assessment is performed. U.S. adults with primary hypercholesterolemia, 40-75 years of age. 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. LDL-cholesterol between 70 and 189 mg/dL. 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: Age < 40 or >75 years of age Women who are pregnant, plan to become pregnant within the next 6 months, or are breastfeeding. Documented liver dysfunction or history of elevated LFTs indicating active liver disease Documented chronic renal dysfunction within the past two years defined as an eGFR<30mL/min/m2. Known hypersensitivity to rosuvastatin or any supplement under investigation (i.e. shellfish allergy, etc.). Currently taking any prescription statin, or other prescription medication/supplements to treat elevated cholesterol or triglycerides. 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. 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. 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.). Fasting Triglycerides >200mg/dl. In the opinion of the investigator, any other condition that will preclude participation in the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luke Laffin, M.D.

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Steven Nissen, M.D.

Organizational Affiliation

The Cleveland Clinic

Official's Role

Study Chair

Facility Information:

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Supplements, Placebo, or Rosuvastatin Study

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