HypercholesterolemiaPhase 2SPORTNCT04846231

Supplements, Placebo, or Rosuvastatin Study

A Phase 2 study testing Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice and Rosuvastatin in people with Hypercholesterolemia, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Hypercholesterolemia
What is being tested?: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice and Rosuvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 203 participants
Where: 1 siteUnited States
Study dates: 23 Apr 2021to 19 Jul 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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%.

Who cannot join

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.

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic
Cleveland, Ohio, 44195

Other trials in United States

About this study

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.

Read the 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.

Conditions: Hypercholesterolemia
Being tested: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice, Rosuvastatin, Placebo
Keywords: LDL & HDL Cholesterol, Statin, Dietary Supplements
Medical subject headings: Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast RiceDietary 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).
RosuvastatinDrug
Also called Crestor
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).
PlaceboOther
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 groups in NCT04846231
Study group	Role	What they receive
Rosuvastatin	Active comparator	5 mg once per day Receives: Drug: Rosuvastatin
Placebo	Placebo comparator	comparable to rosuvastatin 5 mg once per day Receives: Other: Placebo
Fish Oil	Active comparator	Nature Made 2 soft gels per day Receives: Dietary Supplement: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice
Cinnamon	Active comparator	1200mg, 2 capsules per day Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Assess the effect of each supplement on inflammatory markers compared with rosuvastatin 5 mg.
Measured: 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.
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.
Measured: After 4 weeks
The Percent Change in HDL-C, Total Cholesterol, and Triglycerides for Placebo vs the Dietary Supplements.
The percent change in HDL-C, total cholesterol, and triglycerides for each supplement compared with placebo.
Measured: After 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Apr 202119 Jul 2022

First posted15 Apr 2021
Study start23 Apr 2021
Primary completion19 Jul 2022
Study completion19 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
More trials run by The Cleveland ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 203 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04846231
Sponsor's protocol ID: Version 1.0 23February2021
Acronym: SPORT
Status last verified: May 2023
First submitted: 12 Apr 2021
Last updated: 25 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 36351465

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe
Hypercholesterolemia, Dyslipidemias
RecruitingPhase 3
Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Supplements, Placebo, or Rosuvastatin Study
ClinicalTrials.gov ID: NCT04846231
Acronym / sponsor ID: SPORT / Version 1.0 23February2021
Conditions: Hypercholesterolemia
Keywords: LDL & HDL Cholesterol, Statin, Dietary Supplements
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 203 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Collaborators: AstraZeneca
Study start: 23 Apr 2021 (actual)
Primary completion: 19 Jul 2022 (actual)
Study completion: 19 Jul 2022 (actual)
First posted: 15 Apr 2021 (actual)
Results: Posted 25 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 8
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.

Arm	Type	Receives
Rosuvastatin	Active comparator	Drug: Rosuvastatin5 mg once per day
Placebo	Placebo comparator	Other: Placebocomparable to rosuvastatin 5 mg once per day
Fish Oil	Active comparator	Dietary Supplement: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast RiceNature Made 2 soft gels per day
Cinnamon	Active comparator	Dietary Supplement: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice1200mg, 2 capsules per day
Garlique	Active comparator	Dietary Supplement: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast RiceManufactured by Focus Consumer Health Marketgate,1 tablet per day
Turmeric	Active comparator	Dietary Supplement: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast RiceBio Schwartz Turmeric Curcumin 1500 mg, 3 capsules per day
Plant Sterol	Active comparator	Dietary Supplement: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast RiceNature Made CholestOff Plus, 2 soft gels twice a day
Red Yeast Rice	Active comparator	Dietary Supplement: Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast RiceArazo Nutrition 1200 mg, 2 capsules per day

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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%.

Key exclusion criteria (11 listed)

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.).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast RiceSubjects 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).	Dietary supplement	Cinnamon, Fish Oil, Garlique, Plant Sterol, Red Yeast Rice, Turmeric
RosuvastatinAlso: CrestorSubjects 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
PlaceboSubjects 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	Placebo

Primary outcome

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.

3 secondary outcomes

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.
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 Placebo vs the Dietary Supplements.
Time frame: After 4 weeks

Results and safety

Results posted to the registry on 25 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rosuvastatin	25	24
Placebo	25	23
Fish Oil	24	22
Cinnamon	25	24
Garlique	25	25
Turmeric	25	25
Plant Sterol	25	24
Red Yeast Rice	25	23

Primary outcome: 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. Least squares mean (95% Confidence Interval). Unit: percent change LDL-C

Measure	Rosuvastatin n = 24	Placebo n = 23	Fish Oil n = 22	Cinnamon n = 24	Garlique n = 25	Turmeric n = 25	Plant Sterol n = 24	Red Yeast Rice n = 23
Percent change from baseline	-37.86 (-42.13 to -33.59)	-2.63 (-6.99 to 1.73)	-3.43 (-7.86 to 1.01)	0.42 (-3.91 to 4.74)	5.13 (0.97 to 9.29)	-1.29 (-5.44 to 2.87)	-4.37 (-8.65 to -0.09)	-6.55 (-10.94 to -2.16)
Difference in Percent Change	0 (0 to 0)	35.22 (29.13 to 41.32)	34.43 (28.28 to 40.58)	38.27 (32.20 to 44.34)	42.98 (37.02 to 48.95)	36.57 (30.61 to 42.54)	33.49 (27.42 to 39.55)	31.31 (25.16 to 37.47)

Rosuvastatin vs Placebo: Mean Difference (Net): 35.22 (95% CI 29.13 to 41.32), p <0.001, ANCOVA
Rosuvastatin vs Fish Oil: Mean Difference (Net): 34.43 (95% CI 28.28 to 40.58), p <0.001, ANCOVA
Rosuvastatin vs Cinnamon: Mean Difference (Net): 38.27 (95% CI 32.20 to 44.34), p <0.001, ANCOVA

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rosuvastatin	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Placebo	1 of 25 (4%)	3 of 25 (12%)	0 of 25
Fish Oil	1 of 24 (4.2%)	1 of 24 (4.2%)	0 of 24
Cinnamon	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Garlique	0 of 25 (0%)	2 of 25 (8%)	0 of 25
Turmeric	0 of 25 (0%)	1 of 25 (4%)	0 of 25
Plant Sterol	0 of 25 (0%)	2 of 25 (8%)	0 of 25
Red Yeast Rice	0 of 25 (0%)	5 of 25 (20%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36351465Laffin 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.
Individual participant dataSharing planned: No

Related trials for Hypercholesterolemia

RecruitingObservational study
A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe
Hypercholesterolemia, Dyslipidemias
RecruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Luke Laffin, M.D. principal investigator

The Cleveland Clinic

Steven Nissen, M.D. study chair

The Cleveland Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04846231, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.