This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Supplements, Placebo, or Rosuvastatin Study (SPORT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04846231
Recruitment Status : Completed
First Posted : April 15, 2021
Results First Posted : May 25, 2023
Last Update Posted : May 25, 2023
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE April 12, 2021
First Posted Date  ICMJE April 15, 2021
Results First Submitted Date  ICMJE April 18, 2023
Results First Posted Date  ICMJE May 25, 2023
Last Update Posted Date May 25, 2023
Actual Study Start Date  ICMJE April 23, 2021
Actual Primary Completion Date July 19, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2023)
Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 12, 2021)
Comparison of the LDL-C lowering of rosuvastatin with dietary supplements. [ Time Frame: 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2023)
  • Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements. [ 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. ]
    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. [ Time Frame: 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 Placebo vs the Dietary Supplements. [ Time Frame: After 4 weeks ]
    The percent change in HDL-C, total cholesterol, and triglycerides for each supplement compared with placebo.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2021)
  • Percent change in hsCRP for rosuvastatin vs dietary supplements. [ 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. ]
    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. [ Time Frame: 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.
  • The percent change in HDL-C, total cholesterol, and triglycerides for placebo vs the dietary supplements. [ Time Frame: After 4 weeks ]
    The percent change in HDL-C, total cholesterol, and triglycerides for each supplement compared with placebo.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Supplements, Placebo, or Rosuvastatin Study
Official Title  ICMJE Supplements, Placebo, or Rosuvastatin Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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.
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
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • 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 Name: Crestor
  • 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).
Study Arms  ICMJE
  • Active Comparator: Rosuvastatin
    5 mg once per day
    Intervention: Drug: Rosuvastatin
  • Placebo Comparator: Placebo
    comparable to rosuvastatin 5 mg once per day
    Intervention: Other: Placebo
  • Active Comparator: Fish Oil
    Nature Made 2 soft gels per day
    Intervention: Dietary Supplement: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice
  • Active Comparator: Cinnamon
    1200mg, 2 capsules per day
    Intervention: Dietary Supplement: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice
  • Active Comparator: Garlique
    Manufactured by Focus Consumer Health Marketgate,1 tablet per day
    Intervention: Dietary Supplement: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice
  • Active Comparator: Turmeric
    Bio Schwartz Turmeric Curcumin 1500 mg, 3 capsules per day
    Intervention: Dietary Supplement: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice
  • Active Comparator: Plant Sterol
    Nature Made CholestOff Plus, 2 soft gels twice a day
    Intervention: Dietary Supplement: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice
  • Active Comparator: Red Yeast Rice
    Arazo Nutrition 1200 mg, 2 capsules per day
    Intervention: Dietary Supplement: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2022)
203
Original Estimated Enrollment  ICMJE
 (submitted: April 12, 2021)
200
Actual Study Completion Date  ICMJE July 19, 2022
Actual Primary Completion Date July 19, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04846231
Other Study ID Numbers  ICMJE Version 1.0 23February2021
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party The Cleveland Clinic
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The Cleveland Clinic
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
Principal Investigator: Luke Laffin, M.D. The Cleveland Clinic
Study Chair: Steven Nissen, M.D. The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date May 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP