Hyperlipidemias
Conditions
Brief summary
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)
Detailed 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.
Interventions
DIETARY_SUPPLEMENTANKASCIN 568-P Red yeast rice capsules
Product ingredients: ANKASCIN 568-P red yeast rice product 440 mg,microcrystalline ,cellulose,Maltodextrin; capsule shell composition: HPMC (hydroxypropyl methylcellulose), purified water, titanium dioxide, gellan gum.
DIETARY_SUPPLEMENTPlacebo Capsules
Maltodextrin was used as a placebo
Sponsors
SunWay Biotech Co., LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
This experiment adopts a block random assignment design, and the system assignment table (Block randomization, block size = 6) randomly generated by the program is given serial numbers and assigned to groups. The probability of assignment to each group is 1/2.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improves total cholesterol (TC) | 24 weeks | Compare the improvement of total cholesterol (TC) between the test group and the placebo group after taking red yeast rice capsules or placebo capsules for 24 weeks. According to the results of Section 9. Statistical method, whether there is a statistical difference between the two groups. |
Countries
Taiwan
Contacts
Primary ContactSean Lin
Outcome results
None listed