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Red yeast rice may lower cholesterol through gut health, study suggests

NCT ID NCT06301906

Disease control Sponsor: Chang Gung Memorial Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how a red yeast rice supplement (LipoCol Forte) affects cholesterol in 41 men aged 35-55 with high cholesterol. Researchers checked blood and stool samples to see changes in cholesterol, heart disease risk, gut bacteria, and bile acids. The goal was to see if the supplement works and is safe for preventing high cholesterol.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

41 people

The number who actually took part.

Started

Feb 2024

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The investigators will collect the TCM constitution questionnaires from patients before taking LipoCol Forte Capsules and every three months after taking the medicine. At the same time, blood will be drawn to detect glycated hemoglobin, fasting blood sugar, insulin, lipids profile, liver and kidney function, creatine kinase, predictive parameters of atherosclerotic cardiovascular disease, and plasma bile acids, etc. Fecal samples will also be collected to analyze the intestinal microbiota and fecal bile acid composition.

Ages

35 to 55 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Aged 35\~55 years old * LDL-C≥130mg/dl or patients with diabetes or chronic kidney disease with LDL-C ≥ 100mg/dl * expected to receive LipoCol Forte Capsule 600mg bid Exclusion Criteria: * Have received anti-hyperlipidemic drugs or red yeast rice treatment within the past month; * Female; * Have experienced rhabdomyolysis or abnormal liver function ALT \>72 U/L due to taking red yeast rice; * Bleeding diseases, such as abnormal platelets, abnormal coagulation factors, or gastrointestinal tract infection within one month * Liver insufficiency ALT \>72 U/L or renal insufficiency eGFR \< 30 mL/min/1.73 m2; * Have ever had coronary heart disease, myocardial infarction or cerebrovascular disease; * Stressful situations, including hospitalization or surgery within the past or next month, and cancer still being treated; * Uncontrolled hypertension (blood pressure ≥160/100 mmHg); * Use antibiotics, probiotics or weight-loss drugs for more than 3 consecutive days within 3 months before inclusion in the study; * Drug abuse or poor compliance; * Use of traditional Chinese medicine in the past month

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Conditions

The condition(s) this trial relates to.

Hypercholesterolemia hyperlipidemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypercholesterolemia

Contacts and locations

Locations

  • Taoyuan branch of Chang Gung Memorial Hospital

    Taoyuan, Taiwan, 333, Taiwan

More trials for these conditions

Other studies related to the condition(s) this trial covers.