Effect of ANKASCIN 568-P Products Regulating Blood Lipid
NCT ID: NCT05737355
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2023-04-01
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ANKASCIN 568-P Red yeast rice capsules
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.
ANKASCIN 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.
Placebo Capsules
Maltodextrin was used as a placebo.
Placebo Capsules
Maltodextrin was used as a placebo
Interventions
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ANKASCIN 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.
Placebo Capsules
Maltodextrin was used as a placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
ALL
No
Sponsors
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SunWay Biotech Co., LTD.
INDUSTRY
Responsible Party
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Principal Investigators
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WEN-HUI FANG, Ph. D.
Role: PRINCIPAL_INVESTIGATOR
Chief of Family medicine department
Locations
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Tri-Service General Hospital, National Defense Medical Center, Taipei city,
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Hajar R. Risk Factors for Coronary Artery Disease: Historical Perspectives. Heart Views. 2017 Jul-Sep;18(3):109-114. doi: 10.4103/HEARTVIEWS.HEARTVIEWS_106_17. No abstract available.
Lin YL, Wang TH, Lee MH, Su NW. Biologically active components and nutraceuticals in the Monascus-fermented rice: a review. Appl Microbiol Biotechnol. 2008 Jan;77(5):965-73. doi: 10.1007/s00253-007-1256-6. Epub 2007 Nov 22.
Echaniz-Laguna A, Mohr M, Tranchant C. Neuromuscular symptoms and elevated creatine kinase after statin withdrawal. N Engl J Med. 2010 Feb 11;362(6):564-5. doi: 10.1056/NEJMc0908215. No abstract available.
Hsu LC, Hsu YW, Hong CC, Pan TM. Safety and mutagenicity evaluation of red mold dioscorea fermented from Monascus purpureus NTU 568. Food Chem Toxicol. 2014 May;67:161-8. doi: 10.1016/j.fct.2014.02.033. Epub 2014 Feb 28.
Lee CL, Wen JY, Hsu YW, Pan TM. Monascus-fermented yellow pigments monascin and ankaflavin showed antiobesity effect via the suppression of differentiation and lipogenesis in obese rats fed a high-fat diet. J Agric Food Chem. 2013 Feb 20;61(7):1493-500. doi: 10.1021/jf304015z. Epub 2013 Feb 8.
Lee CL, Kung YH, Wu CL, Hsu YW, Pan TM. Monascin and ankaflavin act as novel hypolipidemic and high-density lipoprotein cholesterol-raising agents in red mold dioscorea. J Agric Food Chem. 2010 Aug 25;58(16):9013-9. doi: 10.1021/jf101982v. Epub 2010 Jul 28.
Lee CL, Hung YP, Hsu YW, Pan TM. Monascin and ankaflavin have more anti-atherosclerosis effect and less side effect involving increasing creatinine phosphokinase activity than monacolin K under the same dosages. J Agric Food Chem. 2013 Jan 9;61(1):143-50. doi: 10.1021/jf304346r. Epub 2012 Dec 24.
Chen CL, Pan TM. Red mold dioscorea: a potentially safe traditional function food for the treatment of hyperlipidemia. Food Chem. 2012 Sep 15;134(2):1074-80. doi: 10.1016/j.foodchem.2012.03.019. Epub 2012 Mar 16.
Lee CL, Wen JY, Hsu YW, Pan TM. The blood lipid regulation of Monascus-produced monascin and ankaflavin via the suppression of low-density lipoprotein cholesterol assembly and stimulation of apolipoprotein A1 expression in the liver. J Microbiol Immunol Infect. 2018 Feb;51(1):27-37. doi: 10.1016/j.jmii.2016.06.003. Epub 2016 Jun 24.
Liu SF, Wang YR, Shen YC, Chen CL, Huang CN, Pan TM, Wang CK. A randomized, double-blind clinical study of the effects of Ankascin 568 plus on blood lipid regulation. J Food Drug Anal. 2018 Jan;26(1):393-400. doi: 10.1016/j.jfda.2017.04.006. Epub 2017 Jun 1.
Other Identifiers
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23 ANKASCIN 568-P
Identifier Type: -
Identifier Source: org_study_id
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