SPORT: Supplements, Placebo, or Rosuvastatin Study

Sponsor
The Cleveland Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT04846231
Collaborator
AstraZeneca (Industry)
203
1
8
14.9
13.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice
  • Drug: Rosuvastatin
  • Other: Placebo
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
203 participants
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.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)
Masking Description:
Subjects, investigator staff, persons performing the assessments, and the clinical trial team will be blinded to assigned study group.
Primary Purpose:
Treatment
Official Title:
Supplements, Placebo, or Rosuvastatin Study
Actual Study Start Date :
Apr 23, 2021
Actual Primary Completion Date :
Jul 19, 2022
Actual Study Completion Date :
Jul 19, 2022

Arms and Interventions

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).

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of the LDL-C lowering of rosuvastatin with dietary supplements. [The percent change in LDL-C for rosuvastatin 5 mg compared with dietary supplements after 4 weeks]

      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

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

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

    2. Percent change in HDL-C, total cholesterol, and triglycerides for rosuvastatin vs dietary supplements. [After 4 weeks]

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

    3. The percent change in HDL-C, total cholesterol, and triglycerides for placebo vs the dietary supplements. [After 4 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cleveland Clinic Cleveland Ohio United States 44195

    Sponsors and Collaborators

    • The Cleveland Clinic
    • AstraZeneca

    Investigators

    • Principal Investigator: Luke Laffin, M.D., The Cleveland Clinic
    • Study Chair: Steven Nissen, M.D., The Cleveland Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Cleveland Clinic
    ClinicalTrials.gov Identifier:
    NCT04846231
    Other Study ID Numbers:
    • Version 1.0 23February2021
    First Posted:
    Apr 15, 2021
    Last Update Posted:
    Aug 2, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by The Cleveland Clinic
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 2, 2022