Phase 2
N=199
Supplements, Placebo, or Rosuvastatin Study
Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT04846231 ↗Enrolled (actual)
199
Serious AEs
1.0%
Results posted
May 2023
Primary outcome: Primary: Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. — -37.86; -2.63; -3.43; 0.42 percent change LDL-C — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice (Dietary_supplement); Rosuvastatin (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. |
-37.86; -2.63; -3.43; 0.42; 5.13; -1.29 | <0.001 sig |
| SECONDARY Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements. |
-5.70; -7.12; -1.39; 29.04; 1.09; -4.49 | — |
| SECONDARY Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. |
3.44; 3.08; 2.41; -2.33; 3.43; 1.42 | 0.05 |
| SECONDARY The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. |
3.44; 3.08; 2.41; -2.33; 3.43; 1.42 | — |
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.
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 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 200mg/dl.
- In the opinion of the investigator, any other condition that will preclude participation in the study.
Data sourced from ClinicalTrials.gov (NCT04846231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.