Who is sponsoring NCT04846231?

NCT04846231 is sponsored by The Cleveland Clinic.

What condition does NCT04846231 study?

NCT04846231 studies Hypercholesterolemia.

Is NCT04846231 still recruiting?

NCT04846231 is currently completed. Last updated 25 May 2023.

Are results published for NCT04846231?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-05-25 · How we verify

NCT04846231: SPORT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Supplements, Placebo, or Rosuvastatin Study

Completed Phase 2 Results posted Last updated 25 May 2023

What this trial tests

Phase 2 trial testing Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice in Hypercholesterolemia in 203 participants. Completed in 19 July 2022.

Timeline

23 April 2021

Primary endpoint
19 July 2022

19 July 2022

Quick facts

Lead sponsor	The Cleveland Clinic
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	203
Start date	23 April 2021
Primary completion	19 July 2022
Estimated completion	19 July 2022
Sites	1 location across United States

Drugs / interventions tested

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice
Rosuvastatin (rosuvastatin) — full drug profile →
Placebo

Conditions studied

Hypercholesterolemia — all drugs for Hypercholesterolemia →

Sponsor

The Cleveland Clinic

Who can join

Adults 40 to 75, any sex, with Hypercholesterolemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Percent change from baseline

Group	Value	95% CI
Rosuvastatin	-37.86	-42.13 – -33.59
Placebo	-2.63	-6.99 – 1.73
Fish Oil	-3.43	-7.86 – 1.01
Cinnamon	0.42	-3.91 – 4.74
Garlique	5.13	0.97 – 9.29
Turmeric	-1.29	-5.44 – 2.87
Plant Sterol	-4.37	-8.65 – -0.09
Red Yeast Rice	-6.55	-10.94 – -2.16

Difference in Percent Change

Group	Value	95% CI
Rosuvastatin	0	0 – 0
Placebo	35.22	29.13 – 41.32
Fish Oil	34.43	28.28 – 40.58
Cinnamon	38.27	32.20 – 44.34
Garlique	42.98	37.02 – 48.95
Turmeric	36.57	30.61 – 42.54
Plant Sterol	33.49	27.42 – 39.55
Red Yeast Rice	31.31	25.16 – 37.47

Percent Change in hsCRP for Rosuvastatin vs Dietary Supplements. Secondary · 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.

percentage change from baseline

Group	Value	95% CI
Rosuvastatin	-5.70	-32.52 – 31.78
Placebo	-7.12	-34.06 – 30.83
Fish Oil	-1.39	-30.45 – 39.81
Cinnamon	29.04	-7.94 – 80.88
Garlique	1.09	-27.08 – 40.14
Turmeric	-4.49	-31.08 – 32.36
Plant Sterol	-13.72	-38.28 – 20.60
Red Yeast Rice	6.28	-24.42 – 49.43

Difference in percent change

Group	Value	95% CI
Rosuvastatin	0	0 – 0
Placebo	-1.50	-38.92 – 58.86
Fish Oil	4.58	-35.47 – 69.47
Cinnamon	36.85	-15.07 – 120.52
Garlique	7.20	-32.90 – 71.28
Turmeric	1.29	-36.59 – 61.79
Plant Sterol	-8.50	-43.05 – 46.99
Red Yeast Rice	12.71	-30.14 – 81.83

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

Percent change from baseline HDL-C

Group	Value	95% CI
Rosuvastatin	3.44	-0.73 – 7.62
Placebo	3.08	-1.16 – 7.32
Fish Oil	2.41	-1.91 – 6.73
Cinnamon	-2.33	-6.47 – 1.80
Garlique	3.43	-0.61 – 7.47
Turmeric	1.42	-2.62 – 5.45
Plant Sterol	-4.02	-8.16 – 0.13
Red Yeast Rice	2.45	-1.79 – 6.69

Difference in percentage change HDL-C

Group	Value	95% CI
Rosuvastatin	0	0 – 0
Placebo	-0.37	-6.34 – 5.60
Fish Oil	-1.03	-7.07 – 5.01
Cinnamon	-5.78	-11.71 – 0.16
Garlique	-0.02	-5.86 – 5.83
Turmeric	-2.03	-7.83 – 3.78
Plant Sterol	-7.46	-13.34 – -1.58
Red Yeast Rice	-0.99	-6.91 – 4.92

Percent change from baseline Total Cholesterol

Group	Value	95% CI
Rosuvastatin	-24.43	-27.57 – -21.29
Placebo	-1.44	-4.65 – 1.77
Fish Oil	-2.23	-5.50 – 1.04
Cinnamon	0.37	-2.78 – 3.52
Garlique	2.80	-0.26 – 5.86
Turmeric	-0.75	-3.80 – 2.30
Plant Sterol	-3.89	-7.02 – -0.75
Red Yeast Rice	-2.60	-5.80 – 0.60

Difference in percent change Total Cholesterol

Group	Value	95% CI
Rosuvastatin	0	0 – 0
Placebo	22.99	18.49 – 27.48
Fish Oil	22.20	17.65 – 26.74
Cinnamon	24.80	20.36 – 29.23
Garlique	27.23	22.85 – 31.61
Turmeric	23.68	19.30 – 28.06
Plant Sterol	20.54	16.08 – 25.00
Red Yeast Rice	21.83	17.33 – 26.33

Percent change from baseline Triglycerides

Group	Value	95% CI
Rosuvastatin	-19.25	-27.60 – -9.94
Placebo	-1.41	-11.78 – 10.18
Fish Oil	-5.01	-15.19 – 6.40
Cinnamon	8.34	-2.80 – 20.75
Garlique	-5.43	-15.03 – 5.26
Turmeric	0.26	-9.82 – 11.47
Plant Sterol	1.28	-9.17 – 12.93
Red Yeast Rice	4.11	-6.81 – 16.31

Difference in percent change Triglycerides

Group	Value	95% CI
Rosuvastatin	0	0 – 0
Placebo	22.09	4.52 – 42.62
Fish Oil	17.64	0.58 – 37.58
Cinnamon	34.16	14.94 – 56.60
Garlique	17.11	0.41 – 36.60
Turmeric	24.16	6.61 – 44.60
Plant Sterol	25.42	7.49 – 46.35
Red Yeast Rice	28.93	10.36 – 50.63

The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. Secondary · After 4 weeks

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

Percent change from baseline HDL-C

Group	Value	95% CI
Rosuvastatin	3.44	-0.73 – 7.62
Placebo	3.08	-1.16 – 7.32
Fish Oil	2.41	-1.91 – 6.73
Cinnamon	-2.33	-6.47 – 1.80
Garlique	3.43	-0.61 – 7.47
Turmeric	1.42	-2.62 – 5.45
Plant Sterol	-4.02	-8.16 – 0.13
Red Yeast Rice	2.45	-1.79 – 6.69

Difference in percent change HDL-C

Group	Value	95% CI
Rosuvastatin	0.37	-5.60 – 6.34
Placebo	0	0 – 0
Fish Oil	-0.67	-6.68 – 5.35
Cinnamon	-5.41	-11.31 – 0.49
Garlique	0.35	-5.49 – 6.19
Turmeric	-1.66	-7.52 – 4.20
Plant Sterol	-7.09	-13.07 – -1.12
Red Yeast Rice	-0.63	-6.67 – 5.42

Percent change from baseline total cholesterol

Group	Value	95% CI
Rosuvastatin	-24.43	-27.57 – -21.29
Placebo	-1.44	-4.65 – 1.77
Fish Oil	-2.23	-5.50 – 1.04
Cinnamon	0.37	-2.78 – 3.52
Garlique	2.80	-0.26 – 5.86
Turmeric	-0.75	-3.80 – 2.30
Plant Sterol	-3.89	-7.02 – -0.75
Red Yeast Rice	-2.60	-5.80 – 0.60

Difference in percent change total cholesterol

Group	Value	95% CI
Rosuvastatin	-22.99	-27.48 – -18.49
Placebo	0	0 – 0
Fish Oil	-0.79	-5.34 – 3.76
Cinnamon	1.81	-2.71 – 6.33
Garlique	4.24	-0.19 – 8.68
Turmeric	0.69	-3.75 – 5.13
Plant Sterol	-2.45	-6.95 – 2.06
Red Yeast Rice	-1.16	-5.69 – 3.37

Percent change from baseline triglycerides

Group	Value	95% CI
Rosuvastatin	-19.25	-27.60 – -9.94
Placebo	-1.41	-11.78 – 10.18
Fish Oil	-5.01	-15.19 – 6.40
Cinnamon	8.34	-2.80 – 20.75
Garlique	-5.43	-15.03 – 5.26
Turmeric	0.26	-9.82 – 11.47
Plant Sterol	1.28	-9.17 – 12.93
Red Yeast Rice	4.11	-6.81 – 16.31

Difference in percent change triglycerides

Group	Value	95% CI
Rosuvastatin	-18.09	-29.88 – -4.32
Placebo	0	0 – 0
Fish Oil	-3.65	-17.77 – 12.90
Cinnamon	9.88	-5.92 – 28.34
Garlique	-4.08	-17.78 – 11.91
Turmeric	1.69	-12.79 – 18.58
Plant Sterol	2.73	-12.16 – 20.14
Red Yeast Rice	5.60	-9.79 – 23.63

Adverse events — posted to ClinicalTrials.gov

Time frame: 4 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Rosuvastatin

Serious: 0/25 (0%)

Deaths: 0/25

Placebo

Serious: 1/25 (4%)

Deaths: 0/25

Fish Oil

Serious: 1/24 (4%)

Deaths: 0/24

Cinnamon

Serious: 0/25 (0%)

Deaths: 0/25

Garlique

Serious: 0/25 (0%)

Deaths: 0/25

Turmeric

Serious: 0/25 (0%)

Deaths: 0/25

Plant Sterol

Serious: 0/25 (0%)

Deaths: 0/25

Red Yeast Rice

Serious: 0/25 (0%)

Deaths: 0/25

Serious adverse events (2 terms)

Reaction	System	Rosuvastatin	Placebo	Fish Oil	Cinnamon	Garlique	Turmeric	Plant Sterol	Red Yeast Rice
Clinical Change in Liver Function	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Deep Vein Thrombosis	Vascular disorders	—	—	—	—	—	—	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Rosuvastatin	Placebo	Fish Oil	Cinnamon	Garlique	Turmeric	Plant Sterol	Red Yeast Rice
Headache	Nervous system disorders	—	—	—	—	—	—	—	—
Muscle Pain / Tenderness	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—

Most-reported serious reactions: Clinical Change in Liver Function, Deep Vein Thrombosis.

Data from ClinicalTrials.gov NCT04846231 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Comparative Effects of Low-Dose Rosuvastatin, Placebo, and Dietary Supplements on Lipids and Inflammatory Biomarkers.
Laffin LJ, Bruemmer D, Garcia M, Brennan DM, et al · · 2023 · cited 53× · PMID 36351465 · DOI 10.1016/j.jacc.2022.10.013

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04846231 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The Cleveland Clinic
Last refreshed: 25 May 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04846231.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04846231: SPORT

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (2 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Hypercholesterolemia

Other The Cleveland Clinic trials

Verify against primary sources