Effect of ANKASCIN 568-P Products Regulating Blood Lipid

SunWay Biotech

Status: Enrolling

Conditions: Hyperlipidemias

Treatments: Dietary Supplement: ANKASCIN 568-P Red yeast rice capsules; Dietary Supplement: Placebo Capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT05737355

23 ANKASCIN 568-P

Details and patient eligibility

About

This study is a randomized, double-blind, placebo-controlled, parallel-controlled trial (24 weeks in total), divided into three periods (screening, treatment, and discontinuation follow-up)

Full description

This study aims to investigate the effects of long-term consumption of red yeast rice products on blood lipid regulation and elevated high-density lipoprotein cholesterol (HDL-C), while also monitoring changes in the subjects' overall health. This randomized, double-blind, placebo-controlled trial aims to recruit 80 subjects, who will be randomly divided into two groups to receive either a red yeast rice product or a placebo for 24 weeks. The experimental group will take two red yeast rice capsules daily (each containing 440 mg of ANKASCIN 568-P), while the control group will take two similar-looking placebo capsules daily (containing an equal weight of maltodextrin). Blood samples will be collected and recorded for biochemical analysis at 0, 4, 12, and 24 weeks. General postural measurements will be taken, along with blood pressure, blood lipids, and blood glucose levels. Liver, kidney, and thyroid function will also be monitored.

Enrollment: 80 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or Female women over the age of 20 (women of childbearing age should not be pregnant or breastfeeding during the study period).
• A sane and communicative adult.
• 18≦BMI≦35.
• Sub-healthy people with simple dyslipidemia and those who have been judged by the doctor that they do not need to take hypolipidemic drugs for the time being, or those who insist on not taking drugs.
• Screening criteria Low-density lipoprotein cholesterol (LDL-C): 130~190 mg/dL. screening criteria and high-density lipoprotein cholesterol (HLDL-C): below 50 mg/dL.
• Those without other serious diseases (cancer, heart failure, diabetes, myocardial infarction, liver cirrhosis, moderate to severe liver and kidney dysfunction, stroke, etc.).
• During the experiment, the daily routine and eating habits should be maintained and not changed deliberately.

Exclusion criteria

• Triglyceride TG≧500 mg/dL.
• Blood pressure value: systolic blood pressure ≧ 200 mmHg or diastolic blood pressure ≧ 140 mmHg.
• Patients with moderate or severe abnormal liver and kidney function (generally referring to serum aminopyruvate converting enzyme (SGPT), serum glutamate phenylacetate transaminase (SGOT) are more than 3 times the upper limit of normal or have been diagnosed Liver cirrhosis, or glomerular filtration rate eGFR≦30 ml/min/1.73m2).
• Pregnant or lactating women.
• Those who take traditional Chinese medicine mainly based on red yeast rice.
• Those who have undergone surgery within one month.
• Those who have serious diseases such as heart, liver, kidney, and hematopoietic system, mentally ill patients who do not meet the inclusion criteria, fail to use the test product according to the regulations so that the efficacy or safety cannot be judged due to incomplete data.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

ANKASCIN 568-P Red yeast rice capsules

Experimental group

Description:

ANKASCIN 568-P is a fermented product from the red yeast rice fungus \<Monascus purpureus NTU 568\>. It does not contain Monacolin K, an ingredient that may harm the human body, and is rich in new active ingredients. Take 2 red yeast rice capsules (each containing 440mg ANKASCIN 568-P) every day, and the control group takes 2 placebo capsules (containing equal weight maltodextrin) every day, respectively, at the 0th, 4th , , 12, 24, Collect blood samples for biochemical analysis and record the general body position measurement, blood pressure, blood lipid, blood sugar and other related changes of the subjects, and monitor the liver, kidney, and thyroid functions.

Treatment:

Dietary Supplement: ANKASCIN 568-P Red yeast rice capsules

Placebo Capsules

Placebo Comparator group

Description:

Maltodextrin was used as a placebo.

Treatment:

Dietary Supplement: Placebo Capsules