Trial · NCT04846231
Supplements, Placebo, or Rosuvastatin Study
NCT04846231, Phase 2, Completed, The Cleveland Clinic; results first posted 2023-05-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Supplements, Placebo, or Rosuvastatin Study. Trials, record NCT04846231. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04846231
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Supplements, Placebo, or Rosuvastatin Study
- NCT number
- NCT04846231
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 203 participants, actual
- Lead sponsor
- The Cleveland Clinic
- Conditions
- Hypercholesterolemia
- Interventions
- Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice, Rosuvastatin, Placebo
- First posted
- 2021-04-15
- Last updated
- 2023-05-25
- Results first posted
- 2023-05-25
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | The percent change in LDL-C for rosuvastatin 5 mg compared with dietary supplements after 4 weeks | percent change LDL-C | LEAST_SQUARES_MEAN | |
| SECONDARY | 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 hsCRP | LEAST_SQUARES_MEAN | |
| SECONDARY | Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Rosuvastatin vs Dietary Supplements. | After 4 weeks | % change HDLC,Tot Cholest, Triglycerides | LEAST_SQUARES_MEAN | |
| SECONDARY | The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements. | After 4 weeks | % change HDLC, tot chole, triglycerides | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group128
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | Rosuvastatin | Percent change from baseline | -37.86 | 95% Confidence Interval -42.13 to -33.59 | percent change LDL-C |
| Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | Placebo | Percent change from baseline | -2.63 | 95% Confidence Interval -6.99 to 1.73 | percent change LDL-C |
| Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | Fish Oil | Percent change from baseline | -3.43 | 95% Confidence Interval -7.86 to 1.01 | percent change LDL-C |
| Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | Cinnamon | Percent change from baseline | 0.42 | 95% Confidence Interval -3.91 to 4.74 | percent change LDL-C |
| Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | Garlique | Percent change from baseline | 5.13 | 95% Confidence Interval 0.97 to 9.29 | percent change LDL-C |
| Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | Turmeric | Percent change from baseline | -1.29 | 95% Confidence Interval -5.44 to 2.87 | percent change LDL-C |
| Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | Plant Sterol | Percent change from baseline | -4.37 | 95% Confidence Interval -8.65 to -0.09 | percent change LDL-C |
| Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | Red Yeast Rice | Percent change from baseline | -6.55 | 95% Confidence Interval -10.94 to -2.16 | percent change LDL-C |
| Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | Rosuvastatin | Difference in Percent Change | 0 | 95% Confidence Interval 0 to 0 | percent change LDL-C |
| Percent Change in LDL-C From Baseline for Rosuvastatin 5mg Daily Compared With Placebo and Each Dietary Supplement. | Placebo | Difference in Percent Change | 35.22 | 95% Confidence Interval 29.13 to 41.32 | percent change LDL-C |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rosuvastatin | 25 | |
| Overall Study | STARTED | Placebo | 25 | |
| Overall Study | STARTED | Fish Oil | 24 | |
| Overall Study | STARTED | Cinnamon | 25 | |
| Overall Study | STARTED | Garlique | 25 | |
| Overall Study | STARTED | Turmeric | 25 | |
| Overall Study | STARTED | Plant Sterol | 25 | |
| Overall Study | STARTED | Red Yeast Rice | 25 | |
| Overall Study | COMPLETED | Rosuvastatin | 24 | |
| Overall Study | COMPLETED | Placebo | 23 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Muscle Pain / Tenderness | Musculoskeletal and connective tissue disorders | Rosuvastatin | 0 | 25 | 0 |
| other | Muscle Pain / Tenderness | Musculoskeletal and connective tissue disorders | Placebo | 2 | 25 | 2 |
| other | Muscle Pain / Tenderness | Musculoskeletal and connective tissue disorders | Fish Oil | 0 | 24 | 0 |
| other | Muscle Pain / Tenderness | Musculoskeletal and connective tissue disorders | Cinnamon | 0 | 25 | 0 |
| other | Muscle Pain / Tenderness | Musculoskeletal and connective tissue disorders | Garlique | 1 | 25 | 1 |
| other | Muscle Pain / Tenderness | Musculoskeletal and connective tissue disorders | Turmeric | 1 | 25 | 1 |
| other | Muscle Pain / Tenderness | Musculoskeletal and connective tissue disorders | Plant Sterol | 1 | 25 | 1 |
| other | Muscle Pain / Tenderness | Musculoskeletal and connective tissue disorders | Red Yeast Rice | 2 | 25 | 2 |
| other | Headache | Nervous system disorders | Rosuvastatin | 0 | 25 | 0 |
| other | Headache | Nervous system disorders | Placebo | 1 | 25 | 1 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rosuvastatin | 0 | 25 |
| Total, all-cause mortality | Placebo | 0 | 25 |
| Total, all-cause mortality | Fish Oil | 0 | 24 |
| Total, all-cause mortality | Cinnamon | 0 | 25 |
| Total, all-cause mortality | Garlique | 0 | 25 |
| Total, all-cause mortality | Turmeric | 0 | 25 |
| Total, all-cause mortality | Plant Sterol | 0 | 25 |
| Total, all-cause mortality | Red Yeast Rice | 0 | 25 |
| Total, other adverse events | Rosuvastatin | 0 | 25 |
| Total, other adverse events | Placebo | 3 | 25 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36351465 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04846231
GET https://conductscience.org/api/trials/v1/NCT04846231/results?page=2