Supplements, Placebo, or Rosuvastatin Study

NCT04846231 | Completed Phase 2 Results FDA Drug

• 1 other identifier: Version 1.0 23February2021
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia

Keywords

LDL & HDL Cholesterol, Statin, Dietary Supplements

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

• 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 Placebo vs the Dietary Supplements.

  After 4 weeks

Study Arms (8)

Rosuvastatin

ACTIVE COMPARATOR

5 mg once per day

Drug: Rosuvastatin

Placebo

PLACEBO COMPARATOR

comparable to rosuvastatin 5 mg once per day

Other: Placebo

Fish Oil

ACTIVE COMPARATOR

Nature Made 2 soft gels per day

Dietary Supplement: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice

Cinnamon

ACTIVE COMPARATOR

1200mg, 2 capsules per day

Dietary Supplement: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice

Garlique

ACTIVE COMPARATOR

Manufactured by Focus Consumer Health Marketgate,1 tablet per day

Dietary Supplement: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice

Turmeric

ACTIVE COMPARATOR

Bio Schwartz Turmeric Curcumin 1500 mg, 3 capsules per day

Dietary Supplement: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice

Plant Sterol

ACTIVE COMPARATOR

Nature Made CholestOff Plus, 2 soft gels twice a day

Dietary Supplement: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice

Red Yeast Rice

ACTIVE COMPARATOR

Arazo Nutrition 1200 mg, 2 capsules per day

Dietary Supplement: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice

Interventions

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

Rosuvastatin 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).

Also known as: Crestor

Rosuvastatin

Placebo 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).

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• AstraZeneca: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• 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.

  PMID: 36351465 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Fish Oils; Curcumin; Phytosterols; red yeast rice; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids; Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Sterols; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Membrane Lipids; Phytochemicals; Biological Factors; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Luke Laffin, MD
• Organization: Cleveland Clinic

Laffinl@ccf.org

216-372-4315

Study Officials

• Luke Laffin, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Steven Nissen, M.D.

  The Cleveland Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Subjects, investigator staff, persons performing the assessments, and the clinical trial team will be blinded to assigned study group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 15, 2021
• Study Start: April 23, 2021
• Primary Completion: July 19, 2022
• Study Completion: July 19, 2022
• Last Updated: May 25, 2023
• Results First Posted: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)