Effect of ANKASCIN 568-P Products Regulating Blood Lipid

NCT05737355 | Recruiting

• 1 other identifier: 23 ANKASCIN 568-P
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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)

Conditions

Hyperlipidemias

Outcome Measures

Primary Outcomes (1)

• Improves total cholesterol (TC)

  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.

  24 weeks

Study Arms (2)

ANKASCIN 568-P Red yeast rice capsules

EXPERIMENTAL

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.

Dietary Supplement: ANKASCIN 568-P Red yeast rice capsules

Placebo Capsules

PLACEBO COMPARATOR

Maltodextrin was used as a placebo.

Dietary Supplement: Placebo Capsules

Interventions

ANKASCIN 568-P Red yeast rice capsules DIETARY_SUPPLEMENT

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.

ANKASCIN 568-P Red yeast rice capsules

Placebo Capsules DIETARY_SUPPLEMENT

Maltodextrin was used as a placebo

Placebo Capsules

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ≦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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SunWay Biotech Co., LTD.: lead

Study Sites (1)

Tri-Service General Hospital, National Defense Medical Center, Taipei city,

Taipei, 114202, Taiwan

RECRUITING

Related Publications (10)

• 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.

  PMID: 29184622 RESULT

• 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.

  PMID: 18038131 RESULT

• 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.

  PMID: 20147729 RESULT

• 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.

  PMID: 24582683 RESULT

• 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.

  PMID: 23360447 RESULT

• 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.

  PMID: 20666456 RESULT

• 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.

  PMID: 23237237 RESULT

• 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.

  PMID: 23107730 RESULT

• 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.

  PMID: 27422746 RESULT

• 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.

  PMID: 29389579 RESULT

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• WEN-HUI FANG, Ph. D.

  Chief of Family medicine department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sean Lin

CONTACT

02-27929568; sean.lin@sunway.cc

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 21, 2023
• Study Start: April 1, 2023
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)